World as Collage: Arts Calendar August 11-17

arts calendar los angelesFantasy video collage, esoteric world building, the unrealness of reality, intentional futures, avant-garde feminist and history-minded community film festivals, visualized sound-based sculptures, an arts party in Crenshaw, a gallery’s unconventional materials challenge, photography benefiting sex workers, comedy benefiting reproductive justice, dance about war and modern folklore, yoga in community, photography elevating the daily commute.

world collage arts calendar

Steven Arnold at Fahey/Klein

Thursday, August 11

Steven Arnold: Theophanies at Fahey/Klein Gallery. Arnold’s work engages themes of spirituality and sexuality, often with great humor, while referencing traditional world religious iconographies and philosophies. Through his tableau photographs, films, sculptures, and drawings, Arnold explored myth and mystery, androgyny and beauty, humor and artifice, life and mortality through intricate black and white photographs depicting reimagined gods, goddesses, spirit guides and archetypes. 148 N. La Brea; Hollywood; Opening reception: Thursday, 7-9pm; On view through September 24; free; faheykleingallery.com.

Jimmy Edgar at Vellum LA

Jimmy Edgar: Oxygen at Vellum LA. In a continuation of the artist’s exploration into metaphysical (and literal) phases of matter, while playing with immateriality in the digital domain, Oxygen comprises 13 new works exploring the portrayal of ideas as evaporated forms of physical creations, and how they might materialize into reality. Through a metaphysical process that Jimmy coins “digital condensation,” the imagination solidifies as literal objects, addressing the inner workings of the creative mind and how ideas move organically from abstract to tangible. 7673 Melrose Ave., West Hollywood; Opening reception: Thursday, August 11, 7-9pm; On view through September 11; free; vellumla.com.

Zwelethu Machepha in Art Genesis

Friday, August 12

Art LeadHer presents Art Genesis: The Beginning of Legacy. Original works from 11 global artists committed to advancing Black culture. These emerging artists hail from countries such as Canada, Congo, Ghana, Jamaica, Nigeria, and the U.S. For this installation, Art LeadHer’s founder and curator Mashonda Tifrere not only sought to bring together a diverse group of emerging artists, but those employed their various mediums in innovative ways to express their personal beliefs, needs, and visions. 3118 W. Sunset Blvd., Silver Lake; Opening day: Friday, August 12, noon-6pm; On view through August 19; free; artleadher.com

Street Art Alive at the Lume

Creative Dating Singles Mixer in Street Art Alive at The Lume. Dating apps are terrible and bars are sketchy but folks crave attention, affection, flirtation, companionship, conversation. One of the more offbeat events in the series of activations at the dazzling bright lights, big colors immersive show Street Art Alive (they’ve done poetry, dance, and music) this time they’re hosting a singles night — a rather genius idea actually, where potential matches are pre-self-selected as being art lovers and there’s no shortage of ice breaker material in the form of the vivid environment itself. 1933 S. Broadway, downtown; Friday, August 12, 5-7:30pm; Tickets: $35; thelume.com.

Les Femmes Underground Film Festival

Saturday, August 13

Les Femmes Underground International Film Festival at the Aero Theater. Centered on the subversive, unique, and innovative, LEFUFF showcases artists redefining how womxn are represented in mainstream cinema​ via the underground world of feminist inter-sectional art, music, and celluloid fantasies. Featuring films from over 30 different countries ranging in genres from documentary to experimental, narrative, horror, female sexuality, and psychotropic, the programing digs into the esoteric realms, of witchcraft and feminism as a way to impart equality, independence, and empowerment. 1328 Montana Ave., Santa Monica; Saturday, August 13, 1-6pm; $15; lesfemmesinternational.org.

Acoustic sculpture by Michael Brewster

Within Sound: The Acoustic Sculptures of Michael Brewster at Mt. Wilson Observatory. An immersive auditory experience conceived by the late Southern California-based artist, Michael Brewster who designed and manipulated sound waves in architectural spaces to engage listeners within auditory fields. Brewster’s works — as much about science as they are about art — have been expertly adapted for the space inside the site’s famous 100-inch Dome. There are two ways to experience this art — a performance of the works along with a lecture and reception, or a performance combined with observing through the historic 100-inch telescope. Mt. Wilson Rd., Angeles National Forest; Saturday-Sunday, August 13-14, 3pm, 6pm, 7:30pm (Saturday only); $50-$100; mtwilson.edu.

Jerry Peña at Le Maximum

Jerry Peña: You Ain’t Gotta Lie to Kick It at Le Maximum. Peña creates artworks that are grounded in the visual and material realities of life in Los Angeles. The objects he assembles — a worn pair of checkered Vans, a work glove, crushed beer cans, broken hubcaps, smashed car windshields — invoke habits of making, scavenging, breaking, and fixing common to the working class Mexican American neighborhoods of Southeast Los Angeles where he was raised, summoned as distinctive sources of grit and beauty. 2525 Lincoln Blvd., Venice: Opening reception: Saturday, August 13, 6-10pm; On view through September 18; free; lemaximumvenice.com

Venice Heritage Museum Film Festival (Outdoor). The VHM team has curated a selection of short films celebrating the city’s historic, artistic, and cultural legacy in partnership with Venice Arts, UCLA Film & Television Archive, Venice Institute of Contemporary Art, and Herman Paramount Pathe News. Select clips from the recently launched VHM Oral History Project, featuring Joan Huff (a descendent of one of the first African-American families of Venice) and Boardwalk icon Harry Perry, will be screened in partnership with Why Not Coco? Productions. The evening is a celebration of Venice history and culture told through short form film, plus food and local vendors, to benefit the museum’s projects. Vice Media, 589 Venice Blvd., Venice; Saturday, August 13, 7-10pm; $20; veniceheritagemuseum.org.

Getty 25 Community Arts Festival: Crenshaw (Outdoor). The Getty’s series of free, outdoor community art festivals across Los Angeles this summer in celebration of the Getty Center’s 25th anniversary continues, with a weekend in the Crenshaw district. Immerse yourself in the rich culture, art, and history of L.A.’s Black arts district at Baldwin Hills Crenshaw Plaza with Crenshaw Creative. Hear stories of elders, participate in hands-on workshops, and discover a rapidly growing community of artists, artisans, educators, and performers. Plus, enjoy food vendors, photo booths, giveaways, and an immersive digital experience of Getty collections. Baldwin Hills Crenshaw Plaza; 3650 W. Martin Luther King Jr Blvd.; Crenshaw; Saturday-Sunday, August 13-14, 11am-6pm; free; getty.edu

Carol Milne at bG Gallery

Outside The Box 3 – Artworks with unusual mediums, at bG Gallery. A whimsical and unique group exhibition showcasing unconventional and unexpected approaches to materials and techniques, including glass, thread, metal, text, toys, candy, concrete, sound, light, shadow, wood, paper, paint, found objects, and more. Curated by artist Joella March and featuring work by Stephen Anderson, Michelle Kingdom, Olga Skorokhod, Carol Milne, Dan Levin, Steven Roberts, Cindy Chinn, March herself, Danny Kaplan, Alexandra Dillon, Carol Powell, Gary Raymond, YaYa Chou, Meghan Willis, Suzanne Walsh, and Tm Gratkowski. Bergamot Station Art Center, 2525 Michigan Ave., Santa Monica; Opening reception: Saturday, August 13, 6-9pm; On view through September 5; free; santamonica.bgartdealings.com.

Elizabeth Waterman: Moneygame at Art Bar LA

Sunday, August 14

Elizabeth Waterman: Moneygame: The Show at ArtBarLA. Over a period of five years, Los Angeles-based fine-art photographer Elizabeth Waterman spent her Saturday nights in clubs in five U.S. cities, photographing and building a rapport with the strippers and exotic dancers who make their livelihood there. Waterman celebrates her subjects’ humanity and commitment to mastering their art in service of larger life goals; and for the closing reception of her exhibition of prints from the book, a dance performance and Q&A about the stripper strike in NoHo, which is now in its fourth month (and to which cause a portion of exhibition sales has been donated). 12017 Venice Blvd., Mar Vista; Closing reception: Sunday, August 14, 2-4pm; free; artbarla.com.

Heidi Duckler Dance

Truth or Consequences: Second Nature at Heidi Duckler Dance. A unification of film, dance, music, and conversation that delves into the significance of Slavic cultural stories and experiences, the salon will include a full screening of HDD’s newest dance film series, “Counterintelligence: The Story of Sister Alyonushka and Brother Ivanushka,” a contemporary reimagining of the Russian folktale told in a cheeky telenovela style. The characters are brought to life through a live dance performance of the story’s epilogue, and Artistic Director Heidi Duckler will speak on an expert panel about topics relating to the conflict between Russia and Ukraine. Bendix Building, 1206 Maple; downtown; Sunday, August 14, 7-9pm; $15-$40; heididuckler.org.

Teen Daze

Monday, August 15

NeueHouse x Hello Mcflyy Open featuring Teen Daze at NeueHouse Hollywood. A night of mindful practice and music with artist Teen Daze and Open teacher, neuroscientist Tara Zinnamon, as they co-create a journey through the senses to immerse and ground you in the present moment to elevate your state. After the practice, connect with community over food, drinks, and a DJ set by Martina Mcflyy, the curator of this evening of nightlife with intention. 6121 Sunset Blvd., Hollywood; Monday, August 15, 7pm; $35; neuehouse.com.

Tuesday, August 16

Sister Groundling: My Comedy, My Choice at The Groundlings. Sister Groundings believe a person should have the right to choose when it comes to reproductive health care and everything else too. For this special one night only “aiding and abetting” fundraising show, the fired-up women of improv comedy donate 100% of proceeds to Planned Parenthood. Stay for a post show party with drinks, food, and solidarity. 7307 Melrose Ave., WeHo; Tuesday, August 16, 8pm; $50; groundlings.com

traci kato-kiriyama

Wednesday, August 17

ONE Archives Foundation and Queer Biennial present Hand in Hand featuring traci kato-kiriyama and Imani Tolliver (Virtual). Hand in Hand will feature readings from new works by kato-kiriyama and Tolliver, followed by an exchange between the two authors exploring themes such as intimacy, solidarity, and resonance over their creative practices, bringing together two award-winning artists, poets, and friends. Wednesday, August 17, 5pm; free; onearchives.org.

Casey Kauffmann & John de Leon Martin at Human Resources, installation view (Photo by Shana Nys Dambrot)

Ongoing

Casey Kauffmann & John de Leon Martin at Human Resources. A two person show of painting, drawing, video, and sculpture by artists who each in their way — one extremely analog and the other obsessively screen-based — pursue a maximalist fascination with pleasure and suffering. Both Martin and Kauffmann take on the dual roles of critic and fan, investigating media consumption as an interpersonal act. While Kauffmann’s digital video collages utilize images from reality television and other limitless online resources to examine culture’s relationship with the feminine, Martin’s paintings and drawings, largely inspired by his love of Dungeons and Dragons, employ fantasy tropes to create sites of queer possibility and pain. In his work for this show Martin utilizes fairies, preternatural beings which are a part of nature but mysterious to society at large, as a metonym for being gay. Kauffmann’s drawing practice functions as an inquiry into the representation of femme emotion and hysteria in both art history and popular culture. The landscapes of California, both emotional and actual, also loom large in both artists’ work; but perhaps the greatest commonality between Martin and Kauffmann is that they are both collagists, constantly mining from the media and experiences they love. 410 Cottage Home St., Chinatown: On view through August 20; free; h-r.la.

Dennis Keeley at Palos Verdes Art Center

Ongoing

Dennis Keeley: A Survey of the Quotidian Landscape at Palos Verdes Art Center. A new exhibition of photographs by Keeley explores what is perhaps the most universal experience in greater Los Angeles — driving on the freeway — but speaking to a counterintuitive sense of meditative curiosity and poetic appreciation that is not at all how most people feel when they’re in traffic. Captured through car windows, at a standstill and at speed, these frames chronicle the repetition of a commuter’s route, celebrating its daily variations of weather, mood, fellow vehicles, their fleeting passengers, and the artist’s own state of mind. Each of the atmospheric urban views is paired with a snippet of prose that expresses in myriad ways the old adage — the journey is the destination. 5504 Crestridge Rd., Palos Verdes; On view through August 27, closing reception 2-4pm; free; pvartcenter.org.

Dennis Keeley at Palos Verdes Art Center

Dennis Keeley at Palos Verdes Art Center

Dennis Keeley at Palos Verdes Art Center

Dennis Keeley at Palos Verdes Art Center

Dennis Keeley at Palos Verdes Art Center

Dennis Keeley at Palos Verdes Art Center

Dennis Keeley at Palos Verdes Art Center

Dennis Keeley at Palos Verdes Art Center

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Theatre News: Working Girl musical, Jane Lynch, Ain’t No Mo’, Hamilton and Marvin Gaye,

Theatre News: Working Girl musical, Jane Lynch, Ain’t No Mo’, Hamilton and Marvin Gaye,

Theresa Rebeck joins Broadway aimed Working Girl musical as new book writer. Rebeck has more plays produced on Broadway than any female playwright of our time, Working Girl would mark Rebeck’s Broadway debut as a book writer for a musical. She joins Grammy, Emmy, and Tony Award winner Cyndi Lauper, who will provide music and lyrics, and Tony Award winner Christopher Ashley (Come From Away), who will direct.
Jane Lynch

Jane Lynch

Five-time Emmy Award winner and 2022 Emmy Award nominee Jane Lynch will end her run as “Mrs. Brice” on Sunday, August 14, 2022. Jane Lynch had a long-scheduled vacation set to begin on Monday, August 15 and was set to return to the show on Tuesday, August 23, before departing for the Creative Arts Emmys on Thursday, September 1. Rather than return for one week of performances, the producers have agreed to adjust her final performance to Sunday, August 14. “Mrs. Brice” standby Liz McCartney is scheduled to play the role of “Mrs. Brice” from Tuesday, August 16 – Sunday, September 4, 2022 at Broadway’s August Wilson Theatre (245 West 52nd Street).

Jane Lynch said, “With my long-planned vacation on the books and then the Creative Arts Emmy Awards ceremony in LA on Thursday, September 1, I will take my final curtain call on August 14.  As I embark upon my last week in FUNNY GIRL, my heart is filled with gratitude for this wildly talented company led by Beanie Feldstein and our wonderful audiences for keeping theater alive! I offer a special thanks to my current scene partner Julie Benko and will be back to see my friend Lea Michele light up the lights.”

Emmy Award nominee Lea Michele (Spring Awakening, “Glee”) will star as “Fanny Brice” and four-time Tony Award nominee Tovah Feldshuh (Yentl, “Crazy Ex-Girlfriend”) will star as “Mrs. Brice” beginning Tuesday, September 6, 2022.

Ain’t No Mo’ producers, Academy Award® nominee Lee Daniels and Brian Anthony Moreland, announced today that tickets are now on sale to the general public. Written by and starring Jordan E. Cooper, Ain’t No Mo’ will begin performances on Broadway at the Belasco Theatre (111 W. 44th St) on Thursday, November 3 ahead of an official opening on Thursday, December 1. Tickets are available via www.aintnomobway.com, www.telecharge.com or by calling 212-239-6200.

Having premiered to overwhelming acclaim at The Public Theater, Ain’t No Mo’ dares to ask the incendiary question, “What if the U.S. government attempted to solve racism … by offering Black Americans one-way plane tickets to Africa?” The answer comes in the form of an outrageous and high-octane comedy about being Black in today’s America. From the mischievous mind of the youngest American playwright in Broadway history, Jordan E. Cooper (“The Ms. Pat Show”), Ain’t No Mo’ seamlessly blends sketch comedy, satire and avant garde theater to leave audiences crying with laughter—and thinking through the tears.

Hamilton and Lin-Manuel Miranda, in partnership with Prizeo, part of the Charitybuzz Impact Marketplace, announced the launch of Ham4Choice to raise much-needed funds for organizations providing abortion access and reproductive health services.

Ham4Choice, part of the Ham4Progress community, is a philanthropic effort created in response to the overturning of Roe v. Wade, the landmark 1973 U.S. Supreme Court decision that affirmed the constitutional right to abortion in the United States. Initial partnering beneficiary organizations for Ham4Choice include: Abortion Support Network, ARC Southeast, Ciocia BasiaDeeds Not Words, Planned Parenthood, Profamilias Puerto Rico, The Brigid Alliance, The National Network of Abortion Fund, and The Tuscan Abortion Support Collective.

“We are devastated by the U.S. Supreme Court’s ruling eliminating the right to abortion which has been a right since 1973. In response, we are teaming up with organizations providing support, access, and travel expenses to those seeking these services. 

“We’re stronger when we work together. We can stand up for every person’s right to make decisions about their own body and their own lives. Join HAMILTON & Friends in the fight for reproductive access and reproductive choice today.”

By donating as little as $10 between August 9 and September 22 HERE, participants will be automatically entered for a chance to win a once-in-a-lifetime HAMILTON experience in three great cities around the world, including show tickets, flights, and hotels in New York, London, and Hamburg, Germany. 

The grand prize winner and a guest will be flown to attend HAMILTON’s Opening Night in Hamburg, Germany (performed in German in the first non-English translation) on October 6, where they’ll meet Lin-Manuel Miranda at an exclusive pre-show reception and attend the post-show celebration. Then, they’ll travel to London and New York to see HAMILTON (performed in English) and meet some of the remarkable cast members at each location. Lastly, they’ll go home with signed memorabilia to commemorate the experience.

The more one donates, the more entries one will receive, and the more support will go toward funding abortion access and care.

Abortion Support Network helps people who need to access safe abortions. They provide information on clinics, travel and accommodation, and provide financial assistance to help with costs for those who need it.  They do this for women and pregnant people resident in Ireland, Northern Ireland, the Isle of Man, Malta, Gibraltar, Poland, Romania, Hungary, France, Spain, the Czech Republic and the other EU countries on a case-by-case basis.

ARC Southeast provide funding and logistical support to ensure Southerners receive safe and compassionate reproductive care including abortion services. Through education and leadership development, they build power in communities of color to abolish stigma and restore dignity and justice.

Ciocia Basia is an activist group in Berlin, Germany that can help organize safe abortion for people from countries where it is illegal. They support everyone who needs an abortion, including trans, non-binary and queer people.

Deeds Not Words is an intersectional community that stands for women’s social and economic opportunity, access to reproductive health, freedom from sexual assault, and equal representation in every aspect and at every level.

Planned Parenthood ensures all people have access to the care and resources they need to make informed decisions about their bodies, their lives, and their futures. Founded in 1916, Planned Parenthood is a trusted health care provider, educator, and passionate advocate here in the U.S. as well as a strong partner to health and rights organizations around the world. Each year, Planned Parenthood delivers vital sexual and reproductive health care, sex education, and information to millions of people. 

Profamilias Puerto Rico provides health services in sustainable manner, especially in sexual and reproductive health, with an emphasis on populations in disadvantaged conditions in Puerto Rico. They provide educational services and advocate for the sexual and reproductive rights of diverse individuals, families, and communities.

The Bridget Alliance supports people who must travel long distances for abortion care. Working across the United States, they arrange and fund confidential travel, lodging, childcare, and logistical assistance, closing the gap between the need for an abortion and the ability to access one.

The National Network of Abortion Funds builds power with members to remove financial and logistical barriers to abortion access by centering people who have abortions and organizing at the intersections of racial, economic, and reproductive justice.

The Tucson Abortion Support Collective is a grass-roots practical support group and abortion fund doing work in southern Arizona. TASC provides logistical, emotional, and financial support to people seeking abortion care. In addition to abortion support, TASC provides free pregnancy tests and emergency contraception throughout their region. 

For more information and to donate for a chance to win, please visit: Ham4Choice.com.

Music Icon Marvin Gaye and his son, Marvin Gaye III 
(Photo Courtesy of Marvin Gaye III)

He was known to the world as the “Prince of Soul.” He was the musical genius with a social conscience whose crooning of classic hits such as “I Want You,” “Sexual Healing,” “What’s Going On?” and of course “Let’s Get It On” left an indelible mark on the soundtrack of American life everywhere and even the world.
 Award-winning playwright and producer, Je’Caryous Johnson and the eldest son of the legendary music figure, Marvin Gaye III, are proud to announce that work has begun on the development of an all-new musical celebrating the life and times of Marvin Pentz Gaye, Jr. Through an unprecedented production partnership between Johnson and Gaye, audiences will get to know another side of the musical legend never seen before. With oversight and collaboration from Marvin Gaye III, audiences can expect an authentic and transparent behind-the-scenes accounting of Gaye’s life against the backdrop of Gaye’s incomparable song catalogue, which will be featured in the musical when it debuts in 2023.
The upcoming musical will be written and produced by both Johnson and Gaye III and will trace the iconic singer’s trials, triumphs and tragedies as he ascends from a preacher’s kid turned local pop singing sensation to an international superstar whose music, still today, stirs the soul as well as the conscience. Gaye’s musical imprint not only helped shaped and revolutionize the sound of Motown, but it also extended well beyond his lifespan and influenced the music of modern-day artists such as Chris Brown, Usher and the late Michael Jackson. Like his music, the themes of Gaye’s life— love, struggle, triumph and redemption prove transcendent and marks the making of an impeccable storyline and theatrical musical masterpiece. The musical will be created alongside the lines of the hit shows that preceded it, most notably Motown The Musical and Ain’t Too Proud – The Life and Times of The Temptations that chronicled the legacy of Berry Gordy and some of Motown Record’s most iconic figures.
A legacy as luminous and significant as Marvin’s also demands proper stewarding and masterful storytelling— a skill set that Johnson has mastered. Whether through his love ballads or his transformative sign of the times signature songs and anthems, Marvin Gaye’s music must be immortalized on stage with the merit it so justly deserves and Marvin Gaye III and Johnson’s collaboration marks the moment in time that a musical of this magnitude will finally manifest on stage in honor of Gaye. No other music figure of the time and since has been able to, as eloquently like Gaye, weave the deeds and dealings of a nation with the desire people have to love and create.
“I have the beautiful privilege of collaborating with Marvin Gaye III to celebrate and pay homage to the incredible legacy of Mr. Marvin Gaye,” stated Johnson. “His music has provided a soundtrack for Black America, putting to music our collective experience as a people. I am delighted and excited to show the true makings of the man and uncover the lesser-known side of this legend through this musical. I am grateful to MGIII Global Licensing International, LLC for entrusting me to partner on this project and tell this epic story.” A theater industry veteran, Johnson is one of the most prolific, commercial producers working today. Tallying nearly a quarter of a billion dollars in box office receipts, he has written, directed and produced more than 37 plays seen by millions of theatergoers. To date, Johnson has also toured over 21 stage play productions to sold-out crowds. His most recent stage productions included Redemption of a Dogg, an original bio-musical loosely based on the life and music of rap superstar Snoop Dogg, and Set It Off: Live, a dynamic stage adaptation of the1996 Warner Brothers cult film that starred Queen Latifah, Jada Pinkett-Smith, Kimberly Elise and Vivica A. Fox.

According to Marvin Gaye III, “MGIII Global Licensing International, LLC is ecstatic to celebrate Mr. Gaye and his life’s work. He is one of the greatest artists, if not the best, who stands with the likes of Elvis and Elton John. Our vision is to have complete transparency. Marvin Gaye was a musical genius and a great humanitarian who cared about people and about what’s going on in the world. We are pleased to bring this project to the world.” “Marvin Gaye is one of my favorite artists of all time,” added Johnson. “His music has inspired me as an artist and helped me to endure during some of the toughest times of my own life. I’m excited to be able to dig into the depths of his genius and celebrate the legacy of a man so deserving.” For more details on casting news, musical  information and more, stay tuned to www.jecaryous.com.

Lee Health: Barbershop wellness brings health care directly to Dunbar neighborhood

Research and history show that African Americans are less likely to seek medical care and are often cautious of going to the doctor. With this in mind, Lee Health teamed up with the Florida Department of Health, community partners and Dunbar’s Utopia Unisex Salon to bring care, screenings and support to a familiar, more comfortable setting. Known as Barbershop Wellness, the objectives of this program are to improve the health of our community, to make sure that everyone receives helpful information, and to help our community members get prompt, efficient, compassionate medical care.

Larry Antonucci

Through the Barbershop Wellness program, community volunteers trained by Lee Health offer health tips and services, including:

  • Educational information about specific health needs
  • Blood pressure checks
  • Assistance with connecting to a primary care provider
  • Consultation with a pharmacist and/or physician as available

In addition to screenings and support, one Saturday a month, the program focuses on different and specific areas of health and wellness. The August program was held earlier this month and focused on plant-based diets. Next month, on Sept. 10, from 10 a.m.-noon, the Barbershop Wellness team will share information about avoiding risky substances and behaviors, and on Oct. 1 (from 10 a.m.-noon), the focus is on positive social connections.

The Barbershop Wellness program harnesses the social and cultural capital of Utopia, which is a staple and has been a pillar of the Dunbar community for more than 30 years. This setting allows the health outreach and support to be more intentional. People are more receptive to information when they are comfortable, and that feeling of comfort has made the program successful.

For more information, contact Utopia Unisex Salon at 239-337-7574.

More:Lee Health: Surgical Optimization Center care team coaches patients toward safe surgeries

Larry Antonucci, M.D., MBA is the president & CEO of Lee Health, Southwest Florida’s major destination for health care offering acute care, emergency care, rehabilitation and diagnostic services, health and wellness education, and community outreach and advocacy programs. Visit www.LeeHealth.org to learn more.

The Strength of Our Political Loyalties Changes Our Actual Beliefs

In an email, Enns contended that

regardless of the precise underlying mechanisms (and multiple mechanisms could be at work), the evidence suggests that Trump’s rhetoric had a meaningful effect on the views his supporters expressed about these issues. We are definitely arguing that the attitudes individuals express can be changed by what candidates they support say and do. Although we cannot observe actual beliefs, to the extent that expressing previously unexpressed beliefs has a reinforcing effect, that would also provide evidence of a deepening or potential changing of racial attitudes.

The strong association between Trump support and whites’ views on racial issues, Enns and Jardina argue in their paper,

was not merely a result of Trump attracting racist whites by way of his own racist rhetoric or a reflection of partisan racial sorting that had already occurred; it was also a result of white Trump supporters changing their views to be more in line with Trump’s over the course of his presidential campaign. In other words, Trump not only attracted whites with more conservative views on race; he also made his white supporters more likely to espouse increasingly extreme views on issues related to immigration and on issues like the Black Lives Matter movement and police killings of African Americans.

Andrew M. Engelhardt, a professor of political science at the University of North Carolina—Greensboro, developed a similar line of analysis in his January 2020 paper, “Racial Attitudes Through a Partisan Lens.”

In an email, Engelhardt wrote:

Part of the reason White Democrats and White Republicans hold increasingly different views about Black Americans is due to their partisanship. It’s not just that Democrats with negative views became Republicans, or Republicans with more positive views became Democrats. Rather, people are changing their attitudes, and part of this, I argue, is due to how politicians talk about Black Americans. Republicans, for instance, could have internalized Trump’s negative rhetoric, and increasingly held more negative views. Democrats, similarly, hear Trump say these negative things and they move opposite, holding more positive views.

In his paper, Engelhardt wrote that undergirding past studies of the role of race in politics and policymaking

is an assumption that racial animus feeds political conflict. I turn this conventional wisdom on its head by arguing that political conflict can shape racial attitudes — people’s views and beliefs about groups understood to be racial. Political scientists have failed to examine this possibility, perhaps because racial attitudes are seen as persistent and influential predispositions that form during childhood, long before most Americans become political animals. According to this line of reasoning, individuals use these early formed attitudes to make sense of politics; racial attitudes lead to partisanship.

The ever-growing divide between left and right extends well beyond racial issues and attitudes. In his email, Engelhardt wrote that his results are “suggestive of partisanship motivating changes in other orientations which we might presumably see as more stable and core to individuals.” He cited research showing that “partisanship influences religiosity and religious affiliation” and other studies linking “political concerns to changes in racial self-identification.” Engelhardt added that he has “some unpublished results where I find partisanship leads Democrats to hold more positive views of gay men and lesbians, transgender individuals, and feminists, over time, with Republicans holding more negative views of these groups in the same period (data range 2016-2020).”

In their January 2022 paper, “The Origins and Consequences of Racialized Schemas about U.S. Parties,” Kirill Zhirkov and Nicholas Valentino, political scientists at the Universities of Virginia and Michigan, make an interesting argument, that, in effect, “Two parallel processes structure American politics in the current moment: partisan polarization and the increasing linkage between racial attitudes and issue preferences of all sorts.”

Zhirkov and Valentino continue:

Beginning in the 1970s, Democratic candidates in presidential elections started to attract large/ shares of nonwhite voters whereas Republicans increasingly relied on votes of racially conservative whites. Over the same period, voters’ positions on seemingly nonracial political issues have gradually become more intertwined with racial resentment.

Overall, the two scholars write,

the growing racial gap between the Democratic and Republican support bases leads to formation of racialized stereotypes about the two parties. Specifically, a non-trivial share of American electorate currently views the Democratic Party as nonwhite and the Republican Party as white, though in reality whites continue to be a majority of both parties.

This “imagined racial coalition of each party,” in the view of Zhirkov and Valentino,

carries profound implications for the ongoing discussion in the discipline about affective polarization in American politics: whites feel colder toward the Democratic Party when they imagine its coalition to be more heavily made up on nonwhites and feel warmer toward the Republican Party when they perceive it to be dominated by their racial group. As a consequence, rather than a cause, they may then come to accept a more conservative issue package advocated by the modern Republican Party.

Racial attitudes, the authors argue persuasively, “are now important predictors of opinions about electoral fairness, gun control, policing, international trade and health care.”

There are, Zhirkov and Valentino note, long-range implications for the future of democracy here:

As soon as ethnic parties start to compete for political power, winning — rather than implementing a certain policy — becomes the goal in and of itself due to associated boost in group status and self-esteem of its members. Moreover, comparative evidence suggests that U.S. plurality-based electoral system contributes to politicization of ethnic cleavages rather than mitigates them. Therefore, the racialization of American parties is likely to continue, and the intensity of political conflict in the United States is likely to grow.

I asked the authors how they would characterize the importance of race in contemporary American politics. In a jointly written email, they replied that in research to be published in the future, “we show that race is at least as strong, and often stronger, than cleavages such as religion, ideology, and class.”

The pessimistic outlook for the prospect of a return to less divisive politics revealed in many of the papers cited here, and the key role of racial conflict in driving polarization, suggest that the ability of the United States to come to terms with its increasingly multiracial, multiethnic population remains in question. This country has been a full-fledged democracy for less than 60 years — since passage of the 1965 Voting Rights Act and the changes wrought by three additional revolutions: in civil rights, women’s rights and gay rights. These developments — or upheavals — and especially the reaction to them have tested the viability of our democracy and suggest, at the very least, an uphill climb ahead.

Michigan US Navy Veterans Mesothelioma Advocate Urges the Family of a Career Navy Veteran with Mesothelioma in Michigan to call the Legal Team at Danziger & De Llano About Compensation It Might Be Millions of Dollars

Michigan US Navy Veterans Mesothelioma Advocate Urges the Family of a Career Navy Veteran with Mesothelioma in Michigan to call the Legal Team at Danziger & De Llano About Compensation It Might Be Millions of Dollars – African American News Today – EIN Presswire

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US Median Age for Giving Birth Hits 30

By Raquel Rogers | Houston Defender | Word In Black

This post was originally published on Defender Network

(WIB) – For Allyson Jacobs, life in her 20s and 30s was about focusing on her career in health care and enjoying the social scene in New York City. It wasn’t until she turned 40 that she and her husband started trying to have children. They had a son when she was 42.

Over the past three decades, that has become increasingly common in the U.S., as birthrates have declined for women in their 20s and jumped for women in their late 30s and early 40s, according to a new report from the U.S. Census Bureau. The trend has pushed the median age of U.S. women giving birth from 27 to 30, the highest on record.

As an older parent, Jacobs feels she has more resources for her son, 9, than she would have had in her 20s.

“There’s definitely more wisdom, definitely more patience,” said Jacobs, 52, who is a patients’ services administrator at a hospital. “Because we are older, we had the money to hire a nanny. We might not have been able to afford that if we were younger.”

While fertility rates dropped from 1990 to 2019 overall, the decline was regarded as rather stable compared to previous eras. But the age at which women had babies shifted. Fertility rates declined by almost 43% for women between ages 20 and 24 and by more than 22% for women between 25 and 29. At the same time, they increased by more than 67% for women between 35 and 39, and by more than 132% for women between 40 and 44, according to the Census Bureau analysis based on National Center for Health Statistics data.

Decisions by college-educated women to invest in their education and careers so they could be better off financially when they had children, as well as the desire by working-class women to wait until they were more financially secure, have contributed to the shift toward older motherhood, said Philip Cohen, a University of Maryland sociologist.

Having children later mostly puts women in a better position.They have more resources, more education. The things we demand of people to be good parents are easier to supply when you are older.

PHILIP COHEN, SOCIOLOGIST AT UNIVERSITY OF MARYLAND

In the past, parents often relied on their children for income — putting them to work in the fields, for example, when the economy was more farm-based. But over the last century or more in the U.S., parents have become more invested in their children’s futures, providing more support while they go to school and enter young adulthood, he said.

“Having children later mostly puts women in a better position,” Cohen said. “They have more resources, more education. The things we demand of people to be good parents are easier to supply when you are older.”

Lani Trezzi, 48, and her husband had their first child, a son, when she was 38, and a daughter followed three years later. Even though she had been with her husband since she was 23, she felt no urgency to have children. That changed in her late 30s, once she’d reached a comfortable spot in her career as an executive for a retail company.

“It was just an age when I felt confident all around in the many areas of my life,” said Trezzi, who lives in New Jersey, outside New York City. “I didn’t have the confidence then that I have now.”

Over the last three decades, the largest increases in the median age at which U.S. women give birth have been among foreign-born women, going from ages 27 to 32, and Black women, going from ages 24 to 28, according to the Census Bureau.

With foreign-born women, Cohen said he wasn’t quite sure why the median age increased over time, but it likely was a “complicated story” having to do with their circumstances or reasons for coming to the U.S.

For Black women, pursuing an education and career played roles.

“Black women have been pursuing higher education at higher rates,” said Raegan McDonald-Mosley, an obstetrician and gynecologist, who is CEO of Power to Decide, which works to reduce teen pregnancies and unwanted births. “Black women are becoming really engaged in their education and that is an incentive to delay childbearing.”

The burden will fall disproportionately on women of color, Black women, people without documentation, people living in rural areas, people in the South — where there are a lot of Black women — and in the Midwest.

RAEGAN MCDONALD-MOSLEY, CEO OF POWER TO DECIDE

Since unintended pregnancies are highest among teens and women in their 20s, and more of their pregnancies end in abortion compared to older women, ending Roe v. Wade would likely shift the start of childbearing earlier on average, in a reverse of the trend of the past three decades, “although the magnitude is unknown,” said Laura Lindberg, principal research scientist at the Guttmacher Institute, a research group that supports abortion rights.

“The burden will fall disproportionately on women of color, Black women, people without documentation, people living in rural areas, people in the South — where there are a lot of Black women — and in the Midwest,” said McDonald-Mosley, who also has served previously as chief medical officer of Planned Parenthood Federation of America.

Motherhood also has been coming later in developed countries in Europe and Asia. In the U.S., it could contribute to the nation’s population slowdown since the ability to have children tends to decrease with age, said Kate Choi, a family demographer at Western University in London, Ontario.

In areas of the U.S. where the population isn’t replacing itself with births, and where immigration is low, population decline can create labor shortages, higher labor costs and a labor force that is supporting retirees, she said.

“Such changes will put significant pressure on programs aimed at supporting seniors like Social Security, Medicaid, and Medicare,” Choi said. “Workers may have to pay higher taxes to support the growing numbers of the retired population.”

Although the data in the Census Bureau report stops in 2019, the pandemic over the past two years has put off motherhood even further for many women, with U.S. birth rates in 2020 dropping 4% in the largest single-year decrease in nearly 50 years. Choi said there appears to have been a bit of a rebound in the second half of 2021 to levels similar to 2019, but more data is needed to determine if this is a return to a “normal” decline.

During the pandemic, some women at the end of their reproductive years may have given up on becoming parents or having more children because of economic uncertainties and greater health risks for pregnant women who get the virus, she said.

“These women may have missed their window to have children,” Choi said. “Some parents of young children may have decided to forego the second … birth because they were overwhelmed with the additional child-caring demands that emerged during the pandemic, such as the need to homeschool their children.”

WordInBlack.com

Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study

Introduction

Heavy menstrual bleeding (HMB) affects more than 10 million (or 1 in 5) women annually in the USA.1 International studies report similar incidence rates, affecting 25% to 30% of the women.2,3 The incidence is variable because not all women seek care for their menstrual symptoms, while others may not be aware of when to seek professional advice or the types of treatments available.3,4 Impaired quality of life (QoL) of women affected by HMB significantly impacts health care utilization, which in turn places an economic burden on the healthcare system.5,6 Hysterectomy and endometrial ablation are two different surgical options for menstrual bleeding, although hysterectomy is generally recommended after other therapies have failed. The use of nonresectoscopic endometrial ablation (NREA) devices has become a mainstay in the treatment of HMB in women who no longer desire fertility and are not candidates for or who refuse medical therapy. Similarly, NREA offers a uterine sparing alternative to hysterectomy, the most invasive treatment for HMB. Compared to resectoscopic endometrial ablation (REA) techniques, NREA devices require less training, skill, and experience and have comparable effectiveness with fewer complications. The treatment has a shorter operative time, lower morbidity, faster recovery time, and improved QoL with high patient satisfaction. NREA is easier to perform and often offers the opportunity for the treatment to be completed in the office setting.7–9 In office, NREA can provide physicians with flexibility in their schedules and optimized resource utilization. Further, ability to provide NREA in the office setting may offer greater patient acceptance and access to treatment. To further expand in office use, physician training, patient comfort, anesthesia techniques, and reimbursement needs must be considered.9

The most often cited concern associated with endometrial ablation is the need for subsequent hysterectomy due to new pelvic pain and/or unresolved or recurrent HMB.9–13 Depending upon the type of endometrial ablation, this risk can be greater than 20% within 3 years of treatment.9,14 One issue driving hysterectomy after failed endometrial ablation is the inability to assess the endometrium histologically due to intracavitary scarring induced to varying degrees by some ablation techniques. Furthermore, intracavitary scarring can lead to long-term complications, such as central or cornual hematometra, post ablation tubal sterilization syndrome (PATSS), retrograde uterine bleeding potentially leading to the development of endometriosis, and the possible delay in diagnosis of an endometrial cancer.15 In particular, radiofrequency ablation (RFA), which makes up the majority of NREA (73%) performed annually in the US, has been associated with a high rate of post ablation intrauterine synechiae which may limit the ability to adequately evaluate the endometrium by biopsy or hysteroscopy to address subsequent abnormal uterine bleeding (AUB).10,16–19

The Cerene® Cryotherapy Device (Cerene Device; Channel Medsystems, Inc. Berkeley, CA) is a novel endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium.20,21 The Cerene Device is approved by the Food and Drug Administration (FDA) for use in premenopausal women with HMB resulting from a spectrum of benign causes for whom childbearing is complete. It was developed to address the unmet clinical need for an endometrial ablation device that could be used in the office setting with limited requirements for anesthesia. Cryogenic fluid or gas is known to have an anesthetic effect on the nerves in the uterine tissue.22 During the CLARITY Study, all treatments were performed with paracervical block and 97% of the subjects had only oral pain medication or no pain medication at all during their procedure yet reported minimal discomfort. Seventy-four percent of the treatments were performed in the office setting, and the remainder were performed in a hospital treatment room. Previously published data confirmed that the Cerene device is safe, effective, and well tolerated in the office setting without the need for intravenous sedation.9 This report provides the 24- and 36-month outcomes of subjects after treatment.

Materials and Methods

Study Design

A prospective, multicenter, international, single-arm, open label, non-randomized, study (the CLARITY Study) was conducted to evaluate the safety and effectiveness of the Cerene® Cryotherapy Device. The details and Month 12 outcomes of this study conducted at 11 sites in Canada, Mexico, and the United States of America have been published previously.21 Inclusion criteria were refractory heavy menstrual bleeding with no definable organic cause, women aged between 25 and 50 years, uterine length ≤10cm, endometrial cavity length between 2.5 cm and 6.5 cm, myometrial thickness of ≥10mm, menstrual blood loss with a pictorial blood loss assessment chart (PBLAC) score of ≥150, premenopausal confirmed by follicle stimulating hormone level <30 IU/L when age is >40 years, agrees to use a reliable form of contraception following ablation treatment, and has predictable and cyclic menstruation. Exclusion criteria included pregnancy or a desire to conceive; endometrial hyperplasia; active endometritis; vaginal or uterine infection; active pelvic inflammatory disease or sexually transmitted infection; active genital infection; presence of bacteremia, sepsis, or other active systemic infection; known or suspected abdominal, pelvic, or gynecologic malignancy within the past 5 years; clotting defects or bleeding disorders; abnormal cytology or human papillomavirus testing not treated according to local standards; prior uterine surgery that interrupts the integrity of the uterine wall; a previous low transverse cesarean section with the myometrial thickness <10 mm; previous endometrial ablation procedure; clinically significant adenomyosis based on transvaginal ultrasound; abnormal uterine cavity; current use of an intrauterine device and unwilling to remove the intrauterine device; an implantable contraceptive device; and post-partum <6 months. Malignant or structural causes of heavy menstrual bleeding were ruled out through transvaginal ultrasound, endometrial biopsy, and diagnostic hysteroscopy in all patients.

The study received regulatory approval by Health Canada, Mexico COFEPRIS, and the US Food and Drug Administration (FDA), respectively. The 11 investigative sites utilized the same clinical protocol in accordance with FDA regulations, the Declaration of Helsinki, and the requirements of local ethics committees and regulatory bodies, including those for subject privacy, informed consent, and record retention. The study protocol was approved by Advarra Central Institutional Review Board (IRB) for sites that did not have a local IRB, by the local IRB at Vanderbilt University Medical Center (Nashville, TN), the Research Ethics Committee of the School of Medicine and University Hospital of the Universidad Autónoma de Nuevo León (Monterrey, Mexico), the Research Ethics Committee of the St. Mary Medical Center (Montreal, Quebec, Canada), and the Health Research Ethics Board of Alberta (Edmonton, Alberta, Canada). All required approvals were obtained prior to subject enrollment at each participating investigative site. All subjects provided written informed consent prior to the initiation of any study-related procedures.

A total of 242 women aged 25 to 50 years with HMB underwent endometrial ablation using the Cerene® Cryotherapy Device. Analgesia and local anesthesia were administered per investigator discretion. No subjects received general anesthesia, 3% received IV sedation, and 97% received oral or no medications in addition to a paracervical block. Seventy-four percent of Cerene treatments were performed in the office setting, and the remainder were performed in a hospital treatment room. The primary effectiveness endpoint was a reduction in menstrual bleeding, with success defined as a PBLAC score of ≤75 at Month 12, with the effectiveness rate compared to an FDA-established objective performance criterion (66% for NREA devices).23 The primary safety endpoint was the incidence of serious adverse events (SAEs) and serious device-related adverse events (AEs).

Long-term follow-up evaluations were conducted in person at the clinical site or by telephone by one of the study coordinators at month 24 and month 36. Data collected included gynecological adverse events, subject description of her last menstrual period prior to the follow-up visit (none, lighter than normal, normal, or heavy), contraception status, subject self-report of pregnancy, the need for medical or surgical interventions to treat abnormal uterine bleeding, subject satisfaction (very satisfied, satisfied, dissatisfied, or very dissatisfied), and subject recommendation (definitely, maybe, probably not, or definitely not). Quality of life (QoL) assessments were measured using two validated instruments: the Menorrhagia Impact Questionnaire (MIQ) and the Premenstrual Symptoms Impact Survey (PMSIS™).24,25

A sample size of 242 subjects was determined for the CLARITY study assuming a 75% success rate of the Cerene Device in the intention-to-treat (ITT) population. Considering the possibility of up to a 10% (24 subjects) drop-out, then the Cerene Device had to achieve a success rate of approximately 84% among subjects with a complete Month 12 PBLAC to achieve a success rate in the ITT cohort of 75%. The study protocol was registered at ClinicalTrials.gov (NCT02842736).

Device Description

The Cerene Cryotherapy Device is a single-use, disposable device that uses cryothermal energy to achieve ablation depths of 5 to 9 mm throughout the uterine cavity. The device can treat uterine cavities ranging in length between 2.5 and 6.5 cm with corresponding uterine soundings up to 10 cm. The diameter of the sheath is less than 6 mm. During treatment, liquid N2O flows from a small cylinder located in the device handle and into an inflow line with multiple jets. The cryothermic energy is provided by a liquid-to-gas phase change of nitrous oxide (N2O), which occurs at −86 ℃. The liquid N2O is infused into a polyurethane liner where it converts into gas. This conformable liner enables coverage of irregular surfaces of the uterine cavity. The status and sequential operating instructions are displayed on the device’s display screen and guide the user through the procedure. When treatment is initiated, automated leak and perforation detection tests are performed. After completion of these tests, N2O flows for the duration of the 2.5-minute treatment.20

Data Analysis

Descriptive statistical analyses were performed using SAS® software, version 9.3, and Microsoft Access version 2007. To analyze continuous variables, descriptive statistics were used and included the number of subjects (n), mean, standard deviation, median, minimum, and maximum. This study was conducted in accordance with the clinical protocol, Good Clinical Practice guidelines, and International Standards Organization standards. Prior to study enrollment, all required institutional review board approvals were obtained.

Results

Subject demographic data for the 242 subjects have been previously reported and are consistent with those of other GEA clinical studies.21 A total of 210 subjects were available for follow-up at 24 months and 201 subjects were available at 36 months. Subject disposition was compared with data from 12 months published previously (Table 1).21

Table 1 Study Subject Disposition at Months 12, 24, and 36

There were no serious adverse device-related effects reported in the CLARITY Study. The primary effectiveness outcome, with success defined as a PBLAC score of ≤75, was met in 76.9% of the intention-to-treat (ITT) cohort at 12 months, exceeding the FDA success criteria.21 The PBLAC instrument was not used after the Month 12; instead, subjects were asked to describe the last menstrual period (LMP) experienced prior to follow-up visits at Month 12, Month 24, and Month 36. Subjects’ menstrual bleeding remained stable during the long-term follow-up. At Month 12, 90.9% of subjects described their LMP as none, lighter than normal, or normal and 9.1% reported heavy periods. This effect persisted at 36 months, with 88.6% of subjects describing their LMP as none, lighter than normal, or normal and 11.4% reporting heavy periods (Table 2). The full cohort of available subjects at 24 months (210) did not complete subject perception questions (last menstrual period, satisfaction, and recommendation) or QoL instruments because IRB/Ethics Committee approval of the protocol amendment had not been obtained by the time of their visit.

Table 2 Study Description of Her Last Menstrual Period Prior to Follow-Up Visit

Subjects’ satisfaction with the outcome of Cerene treatment and willingness to recommend the procedure to others also remained stable. Eighty-five percent of the subjects reported that they were “satisfied” or “very satisfied” with Cerene treatment at the month 36 visit; 90.7% of the subjects reported they would “definitely” or “maybe” recommend the procedure (Figure 1).

Figure 1 Subject satisfaction with cerene treatment outcome and willingness to recommend.

Note: *At 24 months, the full cohort of available subjects did not complete all questions or questionnaires because IRB/Ethics Committee approval of the protocol amendment had not been obtained by the time of their visit.

Improvement in subjects’ QoL, as measured by the impact of menstrual bleeding on daily activities and the occurrence of premenstrual symptoms, was sustained for 3 years after treatment. At screening, 84% of the subjects reported their daily activities as being limited often, most often, very often, or all the time in the MIQ. However, by month 12, 90% of the subjects reported their activities were not limited or only slightly limited, which persisted through the Month 36 visit (Figure 2). Likewise, 75% of the subjects reported a high incidence of premenstrual symptoms through the PMSIS tool at screening, whereas at 12 months after Cerene treatment, 83% of the subjects reported they were free of symptoms often, most often, very often or all the time. This reduction in premenstrual symptoms was also maintained at month 36 (Figure 3).

Figure 2 MIQ: Impact of heavy menstrual bleeding on work, physical, social/leisure activities.

Note: *At 24 months, the full cohort of available subjects did not complete all questions or questionnaires because IRB/Ethics Committee approval of the protocol amendment had not been obtained by the time of their visit.

Figure 3 PMSIS: Incidence and severity of premenstrual symptoms.

Note: *At 24 months, the full cohort of available subjects did not complete all questions or questionnaires because IRB/Ethics Committee approval of the protocol amendment had not been obtained by the time of their visit.

Adverse events during the first 12 months post-treatment have been reported previously.21 There were 52 gynecologic adverse events reported between months 12 and 36 (Table 3), including one incidence of postcoital bleeding determined to be procedure related. There have been 5 pregnancies reported through 36 months post-treatment, 1 of which was an ectopic pregnancy reported in the first year and was removed surgically. There were 4 pregnancies reported between 12 and 36 months of follow-up, all of which were intrauterine. One intrauterine pregnancy was terminated, and the subject continued in the study. Three pregnancies resulted in preterm (35–36 weeks) live births by caesarean delivery.

Table 3 Gynecologic Adverse Events After Month 12 Through Month 36

By the end of 36 months follow-up, 21 (8.7%) subjects required medical or surgical interventions. Six (2.5%) subjects were treated with medications, 1 (0.4%) subject had a repeat endometrial ablation with another commercial GEA, 1 (0.4%) subject underwent a repeat endometrial ablation with a commercial GEA and concomitant placement of a levonorgestrel-eluting intrauterine device (IUD), and 1 (0.4%) subject had a levonorgestrel-eluting IUD placed (Table 1).

Twelve (5.0%) subjects underwent a hysterectomy by the end of 36 months post-treatment (Table 4). Of these, 6 (50%) were age 40 or less (range 29–39). Ten subjects elected hysterectomy despite decrease in post-ablation menstrual bleeding documented at the Month 12 follow-up visit; six of these subjects met the PBLAC endpoint for treatment success. Hysterectomy was performed prior to the Month 12 visit in two subjects, prior to the Month 24 visit in six subjects, and prior to the Month 36 visit in four subjects. New pelvic pain was not reported as the reason for hysterectomy in the three subjects that had a tubal ligation prior to treatment; one of the three subjects had non-intracavitary uterine fibroids and two reported increased menstrual bleeding.

Table 4 Hysterectomy Post Treatment: Subject Characteristics

Among the 101 subjects who had undergone a tubal ligation prior to cryoablation and were available for a follow-up visit at Month 12 (n=97), Month 24 (n=90), and Month 36 (n=87), none reported symptoms of new pelvic pain suggesting hematometra or post ablation tubal sterilization syndrome (PATSS). Six of these subjects had a reintervention. Three had hysterectomy (two due to unresolved heavy menstrual bleeding and one to symptomatic uterine fibroids). Of the remaining three, two were placed on a hormonal medication and one treated with a levonorgestrel-eluting IUD.

Discussion

This prospective, 3-year follow-up study demonstrated sustained safety and effectiveness of treatment with the Cerene Device, a novel cryoablation device for the treatment of HMB. Reduced bleeding patterns reported by subjects remained relatively constant from month 12 to month 36. Subject QoL improvements with two validated instruments, satisfaction with Cerene treatment, and likelihood of recommending the procedure to family and friends were maintained through the 36-month visit. Overall, the CLARITY study has demonstrated the durability of Cerene treatment. Following Cerene treatment, the cumulative incidence of medical and surgical interventions and hysterectomy was low. The reintervention rate for the Cerene device compares favorably with recently published data for a water vapor endometrial ablation device.14

Several studies have focused on the complications of late onset endometrial ablation failure that eventually requires a hysterectomy.26–31 Symptoms that are characteristic of endometrial ablation failure include persistent or recurrent vaginal bleeding, cyclic pelvic pain, and the inability to adequately access the endometrium.12,26 The number of women reported in the literature undergoing a hysterectomy after ablation is wide ranging. A retrospective cohort analysis of 3681 women aged 25–60 years, who underwent treatment with both resectoscopic and NREA techniques at 30 Kaiser Permanente Northern California facilities found that hysterectomy was subsequently performed in 21% of the subjects. The study demonstrated that women less than 40 years of age have a higher risk of hysterectomy after endometrial ablation and that the hysterectomy risk is highest during the first 3 years of endometrial ablation, but the rate continues to increase through 8 years of follow-up.27 An additional retrospective cohort study of 1169 women, mean age of 41.1, who underwent either a rollerball endometrial ablation or NREA procedure found that subsequent hysterectomy was significantly associated with the type of ablation. Women who underwent rollerball endometrial ablation had a statistically significant higher rate of hysterectomy than women who had a NREA procedure. Among all women who had undergone either rollerball, thermal balloon, radiofrequency, or cryoablation, 13.4% underwent hysterectomy, with 60% to 80% of the hysterectomies occurring within 2 to 3 years after treatment.28 Similarly, a retrospective cohort analysis of 5936 women, mean age of 42.7, who underwent ablation with NREA devices at a single academic affiliated community hospital, observed that 13.8% underwent a hysterectomy and 1.8% had repeat ablation; the overall reintervention rate increased over time.11

The incidence of hysterectomy within 36 months following Cerene treatment was low (5.0%). This is lower than the cited results for women having undergone endometrial ablation procedures with other modalities. Notably, half of the patients who ultimately underwent hysterectomy did so despite documented ablation treatment success by PBLAC score.

A small retrospective analysis of 55 subjects who underwent NREA found that 7.3% experienced PATSS between 8 months and 43 months following ablation. Of these, 3.6% presented with central hematometra.29 Another study that compared laparoscopic supracervical hysterectomy with NREA devices observed an incidence of <1.0% of hematometra for each group.13 In addition, a study of women who underwent thermal balloon ablation found hematometra occurred in 1% to 3% of the subjects.30 Overall, the incidence of PATSS following endometrial ablation procedures appears to be low, ranging from 6% to 8%, and developing within 2 to 3 years.30,31 Among the 101 subjects who underwent tubal sterilization prior to Cerene treatment, there were no reports or findings of hematometra or PATSS through 36 months. Although three subjects who underwent hysterectomy in the CLARITY study had undergone prior tubal sterilization, none had symptoms suggesting hematometra or PATSS. Indeed, one subject had symptomatic uterine fibroids and two had increased menstrual bleeding. Previously described hysteroscopic assessment of the uterine cavity at 12 months after Cerene treatment demonstrated that access to the uterine cavity is preserved in the majority of patients and this likely helps to explain the absence of PATSS thus far.21 As the CLARITY study used a multicenter design, we believe the results can be generalized to the larger population of women with HMB.

There were five pregnancies in subjects through 36 months post-ablation, one of which was an ectopic pregnancy. This reinforces the fact that endometrial ablation should not be regarded as a contraceptive, much less sterilization, procedure. Patients undergoing any type of endometrial ablation should be counseled on the need to continue a reliable form of contraception. Indeed, none of the subjects who became pregnant after Cerene ablation were using contraception despite counseling.

The strengths of our study are that it is a prospective multicenter trial with excellent retention of subjects through the final study visit. Ninety-three percent (n=225) of the subjects had a known outcome. Four (1.6%) subjects withdrew voluntarily and only 13 (5.4%) subjects were lost to follow-up. The limitations of our study include the under-representation of African American women and it was not randomized with a specific comparator ablation technique. Another potential limitation is some of the quality-of-life instruments were administered by phone for the Month 24 and Month 36 visit, thereby possibly introducing bias by the study coordinator. However, we think this risk is low as study coordinators were trained at the beginning of the study how to administer the instruments, questions were asked exactly as they appeared on the questionnaire, the subject was familiar with the questionnaires having completed them in person at screening, Months 3, 6, and 12, and the questionnaires were unchanged.

Conclusion

The Cerene Device provides safe, effective, and durable outcomes through 36 months for the treatment of heavy menstrual bleeding due to benign causes in women for whom childbearing is complete. It allows patients to be treated in the comfort of their physicians’ office in a convenient, efficient fashion which produces a high level of satisfaction.

Data Sharing Statement

Will individual deidentified participant data be available? No. What specific data will be shared? N/A. What other study documents will be available? N/A. How will the data be accessible? N/A. When will the data be available (start and end dates)? N/A.

Acknowledgments

  1. Channel Medsystems Inc. for sponsoring the study and coordinating statistical support from Gordon and Associates, Inc.
  2. Site Primary Investigators (PI) other than the authors: Bruce Allan, MD, PhD; Cindy Basinski, MD; Scott Boyd, MD; Amy Brenner, MD; Claude Fortin, MD; Jose Garza, MD; Eric Hawes, MD; Randall Kahan, MD; Gerard Reilly, MD; Todd Rumsey, MD; and Scott Schade, MD.
  3. Ginny Vachon, PhD (Principal Medvantage, LLC, Atlanta, GA) for editorial assistance.
  4. Portions of this manuscript were presented at the 49th AAGL Global Conference in Austin, Texas, USA, from November 14 to 17, 2021.

Funding

The CLARITY Study was sponsored by Channel Medsystems Inc., Berkeley, CA.

Disclosure

The authors report no conflicts of interest in this work.

References

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3. Su S, Yang X, Su Q, Zhao Y. Prevalence and knowledge of heavy menstrual bleeding among gynecology outpatients by scanning a WeChat QR Code. PLoS One. 2020;15(4):e0229123. doi:10.1371/journal.pone.0229123

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5. Liu Z, Doan QV, Blumenthal P, Dubois RW. A systematic review evaluating health-related quality of life, work impairment, and health-care costs and utilization in abnormal uterine bleeding. Value Health. 2007;10(3):183–194. doi:10.1111/j.1524-4733.2007.00168.x

6. Jensen JT, Lefebvre P, Laliberté F, et al. Cost burden and treatment patterns associated with management of heavy menstrual bleeding. J Women’s Health. 2012;21(5):539–547. doi:10.1089/jwh.2011.3147

7. Levie MD, Chudnoff SG, Prospective A. Multicenter, pivotal trial to evaluate the safety and effectiveness of the AEGEA vapor endometrial ablation system. J Minim Invasive Gynecol. 2019;26(4):679–687. doi:10.1016/j.jmig.2018.07.012

8. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4):418–428. doi:10.1016/S1074-3804(05)60513-0

9. Munro MG. Endometrial ablation. Best Pract Res Clin Obstet Gynaecol. 2018;46:120–139. doi:10.1016/j.bpobgyn.2017.10.003

10. Wortman M. Late-onset endometrial ablation failure. Case Rep Women’s Health. 2017;12(15):11–28. doi:10.1016/j.crwh.2017.07.001

11. Klebanoff J, Makai GE, Patel NR, Hoffman MK. Incidence and predictors of failed second-generation endometrial ablation. Gynecol Surg. 2017;14(1):26. doi:10.1186/s10397-017-1030-4

12. Wortman M, Cholkeri A, McCausland AM, McCausland VM. Late-onset endometrial ablation failure–etiology, treatment, and prevention. J Minim Invasive Gynecol. 2015;22(3):323–331. doi:10.1016/j.jmig.2014.10.020

13. Cooper K, Breeman S, Scott NW, et al.; HEALTH Study Group. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial. Lancet. 2019;394(10207):1425–1436. doi:10.1016/S0140-6736(19)31790-8

14. Leyland N, Harris M. Water vapor endometrial ablation for heavy menstrual bleeding: 36-month follow-up of a prospective, multicenter pivotal clinical trial. Int J Women’s Health. 2021;13:169–176. doi:10.2147/IJWH.S279864

15. McCausland A, McCausland V. Long-term complications of endometrial ablation: cause, diagnosis, treatment, and prevention. J Minim Invasive Gynecol. 2007;14:399–406. doi:10.1016/j.jmig.2007.04.004

16. Ahonkallio SJ, Liakka AK, Martikainen HK, et al. Feasibility of endometrial assessment after thermal ablation.”. Euro J Obstet Gynec Reprod Biol. 2009;147:69–71. doi:10.1016/j.ejogrb.2009.06.014

17. Luo X, Lim C, Li L, et al. Hysteroscopic appearance of endometrial cavity after microwave endometrial ablation. J Minim Invasive Gynecol. 2010;17:30–36. doi:10.1016/j.jmig.2009.09.012

18. MacMahon C, Hatti A, Bakour S, et al. Challenges of endometrial assessment after ablation in women with postmenopausal bleeding – A case series. Obstet Gynecol. 2018;38(3):432–434.

19. Wortman M, Daggett A, Deckman A. Ultrasound-guided reoperative hysteroscopy for managing global endometrial ablation failures. J Min Invasive Gynecol. 2014;21(2):238–244. doi:10.1016/j.jmig.2013.09.011

20. Cerene®. Cryotherapy Device Instructions for Use. Berkeley, CA: Channel Medsystems; 2019.

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22. Evans PJ. Cryoanalgesia. The application of low temperatures to nerves to produce anaesthesia or analgesia. Anaesthesia. 1981;36(11):1003–1013. doi:10.1111/j.1365-2044.1981.tb08673.x

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25. Wallenstein GV, Blaisdell-Gross B, Gajria K, et al. Development and validation of the Premenstrual Symptoms Impact Survey (PMSIS): a disease-specific quality of life assessment tool. J Women’s Health. 2008;17(3):439–450. doi:10.1089/jwh.2007.0377

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August is National Black Business Month!

By Tyronda James
tyrondajames@minorityreporter.net

Happy National Black Business Month! August is National Black Business Month.

The National Black Business Month was the creation of  entrepreneurs, historian John William Templeton and engineer Frederick E. Jordan Sr. to bring attention to the needs of more than two million Black-owned businesses operating across America.

Black Business Month is celebrated annually during the month of August, as a time when individuals and businesses recognize Black-owned businesses across the country.

During Black Business Month, local government officials, community leaders and venture capitalists are encouraged to focus efforts on supporting Black-owned businesses and creating a more hospitable environment in which Black-owned businesses can grow. Black businesses are essential to the people and communities they serve and operate in.

Jordan and Templeton founded the month to “drive the policy agenda affecting the 2.6 million African-American businesses.” They both shared the drive for entrepreneurship of Black businesses and the importance to economic growth. 

Templeton, a historian, business journalist and demographer, was president and executive editor of the oldest Black newspaper in America, eAccess Corp. Frederick E. Jordan didn’t have many financing options when he started his engineering and construction management company in 1969. Now, F. E. Jordan Associates Inc., has international reach, but it led him to realize that the odds are still not in favor of Black entrepreneurship. 

Black business owners account for about 10 percent of U.S. businesses and about 30 percent of all minority-owned businesses. According to the U.S. Census Bureau, that amounts to approximately two million companies owned by African Americans.

Nearly 40 percent of black-owned businesses are in health care and social assistance, repair and maintenance, and personal and laundry services. Other categories include advertising firms, auto dealerships, consulting services, restaurants, barbershops, beauty salons, and more.

Among cities, New York has the most black-owned businesses in the U.S. followed by Atlanta. The highest ratio of black-owned businesses is in Washington, DC where 28% of all businesses are black-owned. The growth of black-owned franchise businesses has been explosive. Five years ago 20% of franchise businesses were black-owned but now it is up to 30%.

Jordan and Templeton’s desire for the celebratory month was to uplift and celebrate Black businesses through the unique and enormous challenges they face, as well as expand the support and existence of Black-owned businesses across the nation.

Black owned businesses create job opportunities and help uplift the spirits of those who live in minority neighborhoods, according to www.moneymatters101.com.

So support a Black Business today. And again, Happy National Black Business Month!

For further information regarding National Black Business Month and ways to support Black-owned businesses visit https://blackmoney.com/ or https://blackmoney.com/nationalblackbusinessmonth/.

Less than one-third of people with hepatitis C get timely treatment

August 09, 2022

3 min read

Source:

Press Briefing.

Disclosures: The authors, Houry and Wester report no relevant financial disclosures.

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New data from a CDC Vital Signs report show that less than one-third of people with hepatitis C receive treatment within 1 year of their diagnosis despite the availability of direct-acting antivirals.

“Roughly 1% of the U.S. adult population has hepatitis C. It is a leading cause of death in the U.S., contributing to the deaths of about 14,000 people each year,” CDC Acting Principal Deputy Director Debra E. Houry, MD, MPH, said during a press briefing.

IDN0822Thompson_Graphic_01_WEB
CDC.

Houry said the number of new HCV infections in the U.S. has steadily increased since 2010, which she said is “another dire outcome of our nation’s opioid crisis.”

“Given this growing burden, it is critical that we understand how to reach more people with hepatitis C treatment, including people with substance use disorder, to save lives and to prevent the ongoing spread of this serious infection,” Houry said.

Researchers used data from HealthVerity — an administrative claims and encounters database — to construct a cohort of adults aged 18 to 69 years with HCV infection who were diagnosed between Jan. 30, 2019, and Oct. 31, 2020. All the participants were continuously enrolled in insurance for 60 days or more before and 360 days or more after diagnosis. The researchers used modeling to assess the association between initiation of direct-acting antiviral (DAA) treatment and sex, age, race, payor and Medicaid restriction status.

Overall, they found that the prevalence of DAA treatment initiation within 360 days of the first positive HCV RNA test result among Medicaid, Medicare and private insurance recipients was 23%, 28% and 35%, respectively. Among those treated, 75% of Medicaid recipients, 77% of Medicare recipients and 84% of private insurance recipients initiated treatment within 180 days of diagnosis.

“Of particular concern was the finding that not all types of insurance are equal,” Carolyn Wester, MD, MPH, Director of CDC’s Division of Viral Hepatitis, said during the briefing.

According to the study, adjusted odds of treatment initiation were lower among those with Medicaid (adjusted OR = 0.54; 95% CI, 0.51-0.57) and Medicare (aOR = 0.62; 95% CI, 0.56-0.68) than among those with private insurance.

“Such disparities could be driven by health system barriers to patient access, lack of provider availability, quality of care, patient distressed, stigma, or language and cultural factors,” Wester said.

After adjusting for insurance type, the study showed that treatment initiation was lowest among adults aged 18 to 29 and 30 to 39 years with Medicaid or private insurance, compared with those aged 50 to 59 years.

Among Medicaid recipients, lower odds of treatment initiation were found among those in states with Medicaid treatment restrictions (aOR = 0.77; 95% CI, 0.74-0.81) than among those in states without restrictions, and among Black or African American people (aOR = 0.93; 95% CI, 0.88-0.99) or among people with any other races not listed as white (aOR = 0.73; 95% CI, 0.62-0.88).

Wester said these findings are especially concerning in the context of higher rates of HCV-related deaths among black and Hispanic people in the U.S.

“To eliminate hepatitis C, all people including younger adults, must have access to unrestricted hepatitis C testing and treatments,” Wester said. “Fortunately, there are things that we can do right now to advance health equity and expand hepatitis C testing and treatment for all people.”

She explained that health care providers, insurers, policymakers and public health professionals should work toward first removing eligibility restrictions and preauthorization requirements that make it difficult for people with HCV to access treatment. They should also consider providing treatment where people with HCV receive other services, such as primary care offices, community clinics, syringe services programs, substance use treatment centers and correctional facilities.

“If we are going to make an impact against hepatitis C, we need to connect more people to treatment and reduce disparities and access diagnosis and treatments,” Wester said. “People shouldn’t have to jump over hurdles to access lifesaving treatments.”

References:

New CDC data reveal less than a third of people diagnosed with hepatitis C receive timely treatment for the deadly, yet curable, infection. https://www.cdc.gov/media/releases/2022/s0809-hepatitis-treatment.html. Published Aug. 9, 2022. Accessed Aug. 9, 2022.

Thompson WW, et al. MMWR Morbid Mortal Wkly Rep. 2022;doi:10.15585/mmwr.mm7132e1.

The Insulin cap shockwave

The historic Inflation Reduction Act that passed on Sunday, Aug. 7, was a big win for Democrats and the Biden administration as they look towards what could be potentially transformational November elections this Fall. 

Despite the win, Republicans were still able to block a crucial measure from being included that would have capped the insulin price at $35 for those privately insured. 

The insulin cap would have given millions across the country the option that many have not had for years, to be able to afford the medicine needed to live. However, with the rejection, millions of diabetics will now have to figure out how to afford the skyrocketing price of insulin all the while inflation soars and the costs of living across the board grows at a rapid pace. 

Once again, those most-affected by the price cap rejection will be marginalized groups, including the Latinx community. The GOP also once again rules against the already disempowered, making them more vulnerable to health and financial consequences as it flexes its close relationships with Big Pharma. 

Many were already having to ration their medicine with others not being able to get it all. Diabetes has direct effects on the body’s organs and causes them to fail, including kidneys. It can also cause blindness if it goes untreated. As a result, it leads those affected to have to get a transplant. 

According to NBC News, one in five people waiting for a transplant are Latinx. 

Per statistics from the Centers for Disease Control and Prevention, diabetes is a lot more common among marginalized groups on the whole. American Indians lead the way, at over 14.7%, the Latinx population follows just below at 12.5%, and the African-American community has the third-highest percentage at 11.7%. For the Latinx population, they are also already predisposed to obesity, diabetes, heart disease, and hypertension.

Along with rates of diabetes in the Latinx population, the flaws of the health care and health insurance system are also a major factor in the prevalence. The way the system is set up, much of the country is uninsured. It means out-of-pocket costs can range upwards to $1,000 and even more in certain cases. According to the CDC, back in 2020 it was revealed that over 32 million Americans were uninsured. Numbers from the Office of Minority Health showed that back in 2019, that over 19% of the Latinx community was uninsured.

With that, when you have more than 10% of citizens not insured, and almost a third of Latinx also uninsured, this can and will create huge disparities and further endanger a community that has always been at risk in this country, whether it be through health disparities, immigration, and other existing injustices. 

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CDC statistics show that Latinx are 70% more likely than their white counterparts to get diagnosed with diabetes. An unhealthy diet and lack of exercise can further lead to being diagnosed, and prevailing economic factors of high food costs sometimes leaves Latinx individuals unable to attain healthier diets and regiments. According to national statistics, Latinx are 1.3 times more likely to die of the disease or complications from it, compared to the white population. 

According to a research article from Health Affairs published last month, 14% of people who need insulin, after food and shelter, are forced to use more than 40% of the family income or personal income to pay for the medicine that has doubled in price in just the last few years. People of color also already have lower rates of health insurance, making it all the less attainable. 

Yadira Sanchez, executive director for Poder Latinx, an organization that builds up Latinx power in Arizona, Florida, and Georgia, said the cap would have “had a tremendous impact in the Latinx community.”

“For us this was very personal… This meant a lot for our families — We need more legislation that really caps those costs to our families especially as inflation is hitting our families extra hard,” she said. 

Texas U.S. Rep. Joaquin Castro, who has lost a family member to diabetes and another currently fighting it, said the high cost of insulin is, “fundamentally a health equity issue.” 

“This isn’t a partisan issue, and it’s shameful that Republican senators are more focused on protecting Big Pharma’s profits than helping diabetics stay alive,” Castro said.