Pharmaceutical

FDA wants more data on safety of transvaginal mesh

Manufacturers of surgical mesh used to repair pelvic floor disorders including pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are being asked by the Food and Drug Administration (FDA) to conduct new studies on the safety of the products.

The review is in response to mounting complaints associated with the transvaginal use of the mesh. Inserted through the vagina to shore up organs that have slumped from childbirth or obesity, the mesh offers an attractive non-invasive alternative to surgical repair. However, complaints show that the mesh often over time begins to erode into the vaginal wall. This causes pain, disability, urinary incontinence, and overall loss in quality of life.

Many women have had to endure more hospitalizations and surgeries to remove the mesh, often finding themselves with lifelong complications.

In an FDA panel review late last year, public citizen groups urged the banning of all transvaginal mesh products claiming the risks far outweighed the devices’ benefits. The FDA advisory panel opted instead to recommend that newer devices go through more rigorous testing before they are approved for use in the treatment of POP and SUI.

The FDA is not required to follow the recommendations of its advisory boards, but the agency’s request for more safety data is promising. Most transvaginal mesh currently on the market was never even tested in clinical trials to determine its safety and efficacy.

Dozens of lawsuits have been filed against makers of surgical mesh, including C.R. Bard and Johnson & Johnson, by women who say they have suffered serious injuries because of the devices.

Source: WSJ