FDA downgrades transvaginal mesh to high-risk category

Class III devices carry a high risk of adverse events. This means that manufacturers will have to submit a premarket approval application to the FDA to show that their version of transvaginal mesh is safe and effective in treating pelvic organ prolapse, a condition that causes a woman’s organs to drop from the lower belly and into the walls of the vagina.

This change has been in the works for years. As Medpage Today reports, it was back in 2011 that the FDA’s Obstetrics and Gynecology devices panel first recommended that transvaginal mesh be moved into the high-risk category. Three years ago, the agency ordered the manufacturers to conduct postmarket studies of women implanted with mesh to see if they were at an unacceptable risk of complications.

Numerous women have suffered side effects like swelling, pain and difficulty having sex due to mesh. Last year, Johnson & Johnson’s Ethicon unit settled a lawsuit filed by one of these women for $5.7 million.

This does not take transvaginal mesh off the market, but it may give women a more accurate picture of the chances that having it put in their bodies will put them at risk of complications.

Medical devices are supposed to make patients’ lives better, not worse. When a company produces a defective device that causes unreasonable harm, victims have the power to get compensation in court.