FDA Grants Approval to intrauterine device for Preventing Uterine Adhesions
The FDA has granted Premarket Approval (PMA) to Womed Leaf®, an intrauterine barrier film designed to reduce the recurrence and severity of postsurgical adhesion formation in the uterus, a condition known as Asherman syndrome.
Womed Leaf® is the first medical device to be approved for sale in the United States for that indication.
Intrauterine Adhesions (IUAs), which refer to the pathological binding of the uterine walls, are caused by scarring of the uterus after procedures such as dilation and curettage or fibroid removal, and can occur in 20% to 45% of those procedures. IUAs are a major cause of infertility, recurrent miscarriages and pain. IUA treatment is plagued with a very high recurrence rate, leaving women unsure and very anxious about their chance to conceive.
Womed Leaf® is intended to reduce the reoccurrence and severity of post-surgical adhesion formation inside the uterus. It consists of a soft thin film made from Womed®'s innovative polymer, which is inserted like an IUD at the end of an adhesiolysis procedure. It expands within the cavity, preventing contact between the uterine walls, and is then naturally and painlessly discharged. The pivotal PREG2 randomized clinical study that enrolled 160 patients with severe or moderate IUA demonstrated that Womed Leaf® significantly reduced the severity of intrauterine adhesion after hysteroscopic adhesiolysis compared with no prevention method and that Womed Leaf® has an acceptable safety profile.
"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. 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," said Dr. Keith Isaacson, MD at Audubon Fertility and Ochsner Health System, New Orleans, LA, who has treated over five hundred Asherman patients. "This is the first FDA approved barrier for these patients and marks a significant improvement for their ultimate desired outcome."
“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,” said Gonzague Issenmann, co-founder and CEO of Womed®. “We are thrilled to help American women in their fight against infertility when Womed Leaf® becomes available in early 2026."
