Will the FDA Grant Ethicon a Pass or Require Post-Market Surveillance?

You may recall we reported on June 4 that Ethicon, a division of Johnson & Johnson (J&J), announced it was removing four synthetic vaginal meshes from the market – all fall under the Gynecare division – the TVT Secur, Prosima, Prolift and the Prolift+M.

An Ethicon spokesman did not call it a recall but a discontinuation.

“This is not a product recall and we continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”

Maybe it’s just a good coincidence that the number of transvaginal lawsuits now numbers in the thousands with the Gynecare division a top focus of these defective product actions. By withdrawing a product from the market, the company avoids a voluntary mesh recall which would allow the U.S. Food and Drug Administration (FDA) to monitor the recall.

In a letter to the state court in New Jersey overseeing Gynecare mesh lawsuits as well as the Charleston, West Virginia District Court, J & J asks the FDA for a favor.

Last January, in a desperate effort to get a handle on the number of ‘adverse events,’ as complication reports are called at the FDA, the agency ordered 35 mesh manufacturers to conduct post-approval monitoring studies for three years.

The FDA has the authority to order such studies under Section 522 of the Federal Food, Drug and Cosmetic Act, but rarely flexes this muscle. The Act authorizes the FDA to require medical device makers to conduct post-market studies if the device’s failure could have a serious adverse health consequence, is used in children, is implanted in the body permanently, or is intending to be life-supporting or sustaining.

A 522 study is a costly procedure, and in the end, it is very unlikely that these studies would give a glowing report to synthetic vaginal mesh used routinely in women to treat incontinence and prolapsed because of the huge complication rate.

Of course, this is just what the FDA should have required the mesh makers to do before they put a permanently implanted polypropylene mesh on the market to treat an inconvenience.

So the question remains- what will the FDA do?  Will it grant the company a pass and allow it to avoid the costly study, or will it stand firm and say, since the meshes will remain on the market for the next 90 days while the “discontinuation” takes place, do the studies!

Stay tuned. We’ll be watching.