An alarmingly high percentage of women who received transvaginal mesh implants to treat pelvic organ prolapse (POP) require additional surgeries years after being implanted with the devices, suggesting that problems with the devices won’t end anytime soon despite the removal of mesh for POP from the market last year.
According to a study published in Obstetrics & Gynecology, women with vaginal mesh for POP needed additional surgeries 40% more often after five years than women with POP who were not treated with the mesh implants. And, about a fifth of the new interventions were performed specifically to address complications related to the transvaginal mesh.
“Even though transvaginal mesh has been removed from the market, our data suggests that the risk of mesh complications does not diminish over time, and these women warrant close follow-up,” concluded study author Bilal Chughtai, MD, of Weill Cornell Medicine in New York City, and colleagues. “Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.”
In April 2019, the Food and Drug Administration (FDA), ordered manufacturers of transvaginal mesh products for POP repair to stop selling the devices due to a high rate of injuries including the mesh eroding into the vagina and the mesh damaging organs and tissue, causing painful sex, chronic pain, bleeding and disability.
“Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair,” the FDA said in a safety communication. “As a result, the agency has taken several, escalating actions for the protection of public health” leading to the removal of the devices from the U.S. market. Manufacturers of transvaginal mesh devices have also been hit with more than 70,000 product liability lawsuits.
