The U.S. Food and Drug Administration has granted PreMarket Approval to Womed Leaf®, marking the first medical device specifically approved in the United States for treating moderate to severe intrauterine adhesions associated with Asherman syndrome[13][16]. This groundbreaking approval represents a significant advancement in women’s reproductive health care, addressing a condition that has long been a major cause of infertility, recurrent miscarriages, and chronic pain for countless women[13]. Asherman syndrome, characterized by the pathological binding of uterine walls due to scarring after procedures such as dilation and curettage or fibroid removal, affects an estimated 20% to 45% of women who undergo these common gynecological interventions[13][16]. The approval comes at a critical time when women’s health issues, particularly those related to fertility and reproductive care, have garnered increased attention in medical and policy discussions across the country[4][8].
Womed Leaf® consists of a soft, thin polymer film designed to be inserted like an intrauterine device at the conclusion of an adhesiolysis procedure[13]. Once in place, the device expands within the uterine cavity, preventing contact between the uterine walls during the critical healing phase, and is then naturally and painlessly discharged from the body[13]. This innovative approach addresses the primary challenge in Asherman syndrome treatment: the high recurrence rate of adhesions following surgical removal[13]. Historically, women undergoing treatment for this condition faced significant uncertainty about their reproductive future, with many experiencing repeated procedures only to have the adhesions return, further diminishing their chances of conception[13]. The pivotal PREG2 randomized clinical study, which enrolled 160 patients with severe or moderate intrauterine adhesions, demonstrated that Womed Leaf® significantly reduced the severity of adhesion recurrence compared to no prevention method, establishing a new standard of care for this challenging condition[13][16].
Medical experts have hailed this approval as a transformative development for women’s health[13]. Dr. Keith Isaacson, MD, of Audubon Fertility and Ochsner Health System in New Orleans, who has treated over five hundred Asherman syndrome patients, noted that ‘Asherman syndrome is a condition that prevents tens of thousands of women in the United States from becoming pregnant due to scar tissue in the uterine cavity[13].’ He explained that ‘When the adhesions are surgically removed, they often return due to the approximation of the uterine walls, which Womed Leaf will prevent during the healing phase,’ emphasizing that ‘This is the first FDA approved barrier for these patients and marks a significant improvement for their ultimate desired outcome[13].’ The device’s approval is particularly significant given the broader context of women’s health care in America, where disparities in reproductive care access and outcomes remain pronounced, especially among women of color and those in underserved communities[4][11].
Gonzague Issenmann, co-founder and CEO of Womed®, expressed enthusiasm about bringing this innovation to American women, stating that ‘The meticulous review and inspections performed by the FDA for the PMA are a clear testimony of the rigorous and world-class work that has been accomplished by our team, and makes Womed Leaf the new standard for Asherman syndrome treatment worldwide[13].’ While the device is expected to become available in early 2026, its approval has already generated considerable discussion among medical professionals and women’s health advocates[13]. This development comes amid growing recognition of the substantial gaps in women’s health research and treatment, with experts estimating that addressing the women’s health gap could add more than $1 trillion to the global economy annually by 2040[12].
The approval of Womed Leaf® represents more than just a new medical device; it signals a broader shift toward addressing conditions that have historically been under-researched and undertreated in women’s health[12][14]. For decades, medical research has often overlooked sex-specific differences in disease presentation and treatment response, resulting in gaps in care for conditions predominantly affecting women[11][15]. The FDA’s approval of this device follows other recent advancements in women’s health, including the approval of Veozah (Fezolinetant) for menopausal symptoms and growing attention to conditions like endometriosis and polycystic ovary syndrome that have long been underdiagnosed and undertreated[14][15]. As women increasingly advocate for better understanding and treatment of their unique health needs, developments like the Womed Leaf® approval suggest a promising trajectory toward more comprehensive, effective care for conditions that impact millions of women across the United States[1][4].