Will the FDA Grant J&J’s Request to Stop the Studies?

TVT Secur

Mesh News Desk, June 9, 2012~ A few folks have asked whether or not the Food and Drug Administration (FDA) has granted Ethicon’s request to place a hold on a three-year study on the complications with transvaginal mesh?

The short answer is, not yet.

No doubt Ethicon, a division of Johnson & Johnson (J&J), was not looking forward to spending in excess millions on the three-year study the FDA ordered last January of Ethicon and other mesh makers to finally get some answers on the actual number of mesh complications, especially when it is facing more than at least 1,100 lawsuits from women injured by mesh.

Background - When the company announced June 4, it would pull four meshes from the market (Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift, and Gynecare Prolift +M) it asked for time to exhaust the supply of meshes still in the market, in other words to continue selling the possibly defective product, but wanted the safety studies halted.

What will the FDA do?

Sarah Clark-Lynn of the FDA’s Public Affairs Office told MDND last Friday, June 8, that the agency has “received Ethicon’s request and have 60 days to respond.”

That means the FDA has until August 4th to issue an answer to Ethicon.

Will it grant the request or require the safety studies for the mesh to continue?

After all, Ethicon will continue to sell the meshes up to nine more months with the goal of completing the process by the first quarter of 2013, according to a company spokesman.

The FDA ordered a 522 study to determine the answers to the following questions and more:

• What proportion of women undergoing transvaginal pelvic organ prolapse surgery is exposed to this device and what sort of surgical procedures are performed?
• What are the rates over 36 months of: mesh exposure into the vagina, mesh erosion into another organ, pelvic pain, infection, dyspareunia (painful sex), vaginal shortening, scarring, bleeding, fistula formation, neuromuscular problems, revision surgery and recurrence?
• What is the quality of life for women who have received this device?
• Is the rate of effectiveness different among women with and without mesh?

For those of you who asked:

“Why should Ethicon continue to profit and not be accountable for its actions?” You can send your question and comments to the following divisions within the FDA:

You may contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at CDRH via email, telephone or fax.

Email: dsmica@fda.hhs.gov or industry.devices@fda.hhs.gov

Telephone: 1-800-638-2041 or 301-796-7100

Also Office of Women’s Health, 301-796-9440, fax 301-847-8604