Will Ethicon Skirt the 522 Request?
In the Ethicon June 4, announcement to two courts that it was taking four synthetic vaginal meshes off the market, Ethicon, a division of Johnson & Johnson, asked that the Food and Drug Administration’s (FDA) January order to conduct postmarket studies be “placed on hold.”
There were about 75,000 women implanted with synthetic mesh to treat conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI) last year. The complication rate is unknown as there is no postmarket surveillance and mesh makers are not required to provide clinical trials to assure safety.
To address some of the many unanswered questions surround mesh, the 522 studies would have forced mesh makers to provide assurances of safety and efficacy.
What was the FDA asking for?
Last January, the FDA exerted its authority and ordered a 522 study of the mesh manufacturers for POP and SUI after the agency noted a five-fold jump in the number of deaths and injuries and complications among women treated with implanted with transvaginal mesh. Background story here.
Thirty-five different makers of mesh for POP and SUI received the letters. See them here.
The FDA has the authority under Section 522 of the Federal Food, Drug, and Cosmetic Act, to require a manufacturer to conduct postmarket surveillance of a Class II or Class III device if, as in the case of mesh, its failure would be reasonably likely to have serious adverse health consequences and/or if the product is intended to be implanted in the body for more than one year.
Vaginal mesh falls under that definition and in an unusual move, the FDA requested the studies to prove safety and efficacy. They were asking the mesh manufacturers to conduct a three – year study with results posted at the 3, 6, 12, 18, 24 and 36 month mark. Questions included:
- 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 receives this device?
- Is the rate of effectiveness different among women with and without mesh?
A 522 study is expensive, easily running into seven figures for multiple meshes. Even though Ethicon was ordered to submit a plan on how it would conduct this postmarket surveillance within 30 days of the January letter, as of June 1, it had not submitted a plan.
Instead, Ethicon is asking the FDA to place the studies “on hold.”Does that indicate the companies know they cannot prove mesh is safe and effective?
At the same time, the largest global provider of synthetic mesh requested it be given 120 days to “cease commercialization” while supplies of the four polypropylene meshes stay on the shelves until supplies are exhausted.
In making that request, Ethicon is asking to continue sales of synthetic vaginal mesh for 4 months while it avoid accountability the 522 surveillance represented. It will be up to the FDA to determine if it will comply with the Ethicon request.
MDND – FDA Orders Manufacturers to Study Mesh Complications, Jan. 5, 2012
MDND – Mesh Makers who Received FDA Letter Requiring Postmarket Surveillance, Jan 9, 2012
MDND – Four J&J Vaginal Meshes Named – Will be Removed from Market, June 5, 2012
Ethicon letter to federal court judge, June 4, 2012:
Ethicon letter to state court judge, June 4, 2012: