On Monday, June 4, in a letter to two different courts, Ethicon, a division of Johnson & Johnson (J&J) announced it was removing four synthetic surgical meshes from the market. All four fall under the Gynecare division – the TVT Secur, Prosima, Prolift and the Prolift+M.
In doing so it avoids a voluntary mesh recall under Food and Drug Administration (FDA) supervision and essentially works the system in its favor as it’s done before.
There were about 3,500 medical device recalls from 2005 to 2009, according to the Government Accountability Office. That means an average of 700 recalls a year were voluntarily conducted under FDA supervision which might include a plant inspection and monitoring the progress of the recall.
But an Ethicon spokesman is very clear when he insists this is not a recall:
“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.”
In this case, Ethicon is voluntarily removing the devices from the market ahead of any potential recall and without FDA oversight.
We know from our clients and the approximately 400 lawsuits already filed in federal court, and 700 in state court in New Jersey, that these pelvic organ and incontinence devices are linked to thousands of injuries in women, many life-altering, as well as a number of deaths. For years, consumer advocates and women’s health patient advocates have been waving the red flag and trying to have them taken off the market, cries that have fallen on deaf ears.
This is where the FDA has dropped the ball to protect patients. Back in October 2008, the federal agency discovered there were an unusual and growing number of adverse events coming into the agency’s database. Even the FDA will acknowledge that its reports represent just a fraction of what is going on in the real world. Back then the FDA didn’t tell patients but instead allowed the sale of mesh to continue. By July 2011 the agency reversed itself and said that complications were not rare and the benefit of mesh might not be worth the risk.
Again the message was subdued and little understood by the public and vaginal mesh remained on the market, unlike the recall of dog food that makes the nightly news.
So it’s no wonder that the tail of corporations is wagging the agency dog with one exception.
In the second paragraph of the Ethicon letter to the courts announcing the withdrawal, Ethicon asks that the FDA’s Office of Surveillance and Biometrics “place the existing 522 orders requiring additional studies for these products on hold. Ethicon is awaiting written confirmation of that plan.”
Last January, the agency finally showed some backbone. Section 522 of the Federal Food, Drug, and Cosmetic Act authorizes the FDA to require manufacturers to conduct post-market surveillance of a Class II or Class III device if:
- its failure would be reasonably likely to have serious adverse health consequences;
- it is expected to have significant use in pediatric populations;
- it is intended to be implanted in the body for more than one year; or
- it is intended to be a life-sustaining or life-supporting device used outside a device user facility.
Numbers 1 and 3 certainly apply to synthetic polypropylene vaginal mesh.
A 522 post-market review can easily cost Ethicon in excess of $1 million and is unlikely, considering the numbers, to be able to prove that mesh is safe and effective. And unlike the 510(k) (short cut approval process)notification process that allowed synthetic mesh on the market in the first place, Ethicon will finally have to prove that its product is not defective and dangerous.
Will the FDA grant the request and not require a 522 review?