FDA Acts on Vaginal Mesh Complications – Where are the Manufacturers?

It appears that news of the complications arising from Vaginal Mesh Kits has prompted the FDA to take action, with meetings scheduled regarding the safety of the kits taking place next week. This is an important step, but, we must continue to ask – where are the manufacturers of the mesh kits?

The manufacturers of the mesh kits are in the best position to warn the public of complications on a timely basis. The FDA estimates that 300,000 women undergo surgeries using vaginal mesh on an annual basis – timely warnings are necessary so that women facing surgery are given all information necessary to make important decisions about their health and safety. To leave the role of safety guardian to a government body that is limited in funding and staffing is unacceptable.

On August 31st, the FDA recommended that the makers of surgical mesh might have to submit added safety data to regulators to keep their products on the market. According to the report, the transvaginally-implanted products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients.

Mesh is a product used to treat pelvic organ prolapse, which occurs when internal organ support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina. As we reported in an earlier blog, the process that approved the mesh kits is currently being reviewed itself.

TorHoerman Law has joined other attorneys and advocate groups in questioning the safety of the vaginal mesh kits and in questioning the monitoring of the safety of these devices.

On a daily basis, we speak to individuals who report life-altering complications arising from the use of mesh. Many of the women affected by the mesh regret they have ever had the procedure performed and some are demanding the recall of the mesh so that other women don’t need to go through what they have gone through.

To allow women with pelvic organ prolapse to undergo the surgery today with little warning about the vaginal mesh kits is unconscionable. We will continue to apply pressure to the manufacturers to warn women and suggest that others should do the same.

Sources: Bloomberg.com, FDA.gov