Pharmaceutical

FDA calls for stricter safety guidelines, pre-market approval for transvaginal mesh for incontinence

vaginal mesh sling FDA calls for stricter safety guidelines, pre market approval for transvaginal mesh for incontinence Stricter safety requirements may be required for the manufacturing of transvaginal mesh under a Food and Drug Administration (FDA) proposal. The surgical mesh used to treat common pelvic floor disorders in women should be reclassified as “high risk,” the agency said in response to mounting reports of complications from the device.

Transvaginal mesh, also known as vaginal mesh or a bladder sling, is used to treat pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have dropped causing symptoms such as discomfort and incontinence.

The mesh was widely used in women in the past decade, but many women have suffered complications such as the mesh eroding into surrounding tissue and protruding into neighboring organs causing symptoms such as bleeding, pain, infections and incontinence. Many women required follow-up surgery to remove the mesh, often undergoing multiple procedures.

The proposal comes three years after the FDA issued a safety announcement that complications with the mesh were not uncommon and women should discuss with their doctors the risks and benefits of getting transvaginal mesh implanted.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, chief scientist for the FDA’s device center.

Transvaginal mesh is currently considered a “moderate risk” device, allowing it fast-track approval status in which approval for new devices is granted if similar products are already on the market. Upgrading the mesh’s status to “high risk” would require further testing for future transvaginal mesh products to prove safety and efficacy before approval is granted.

Transvaginal mesh, made by numerous manufacturers, is the subject of more than 22,000 personal injury lawsuits.

Source: Washington Post