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Gynecare TVM and the FDA As Hall Monitor

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Washington, DCThe parents are never home and the kids are running wild. While this would be good for a laugh in a sitcom (and probably already has, at one time), the premise as a real-life event is fraught with risk and a source of much trouble. A disaster waiting to happen.

Sadly, it appears the foregoing is the very relationship maintained by the US Food and Drug Administration (FDA, otherwise known as the parents), and pharmaceutical and medical device manufacturers in the US (the kids, in this scenario).

Take Gynecare TVM mesh, for example. As noted earlier by, pharmaceutical giant Johnson & Johnson was called out by the FDA for selling the Gynecare Prolift system for a period of three years in absence of the required approvals. The subsidiary of J&J under which Gynecare is sold, Ethicon, eventually announced it would stop selling Gynecare Prolift, Prolift+ M, TVT Secur and Prosima surgical meshes.

But there was never a recall. The farthest the FDA has gone is to require some 32 other manufacturers of transvaginal mesh to conduct post-marketing studies in an effort to identify issues that could adversely affect patients. The FDA has also stated that in its view problems with transvaginal mesh, including migration of the product and perforation through the uterine wall, is not necessarily rare - and that use of transvaginal mesh for repair of Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI) is not the safest treatment option.

And yet, the products are still on the market.

In the case of Gynecare TVM, the recent legal win by a TVM patient of $11.1 million appears to set the stage for a parade of lawsuits that could conceivably cost device manufacturers billions. That kind of hit could be expected to sink the most robust corporation. However, the reality of a restless litigious sea appears to threaten large pharmaceutical and medical device manufacturers with little more than a gentle tide rather than a tsunami.

Last June, Bloomberg News (6/5/12) reported that Gynecare was facing some 600 claims with regard to problematic mesh. Barely a year later, according to PRWeb Newswire (6/24/13), Gynecare is now facing 4,000 claims over its Gynecare Prolift product.

Ethicon eventually stopped selling the allegedly troublesome Gynecare Prolift TVM mesh. But there was never a recall.

Historically, POP and SUI have been repaired using a woman’s own tissue - harvested from elsewhere on the body - to fashion a sling to prevent migration of organs (organ sag) in middle-aged women. The condition is most notably a byproduct of bearing children. But then someone appears to have had the bright idea of using surgical mesh instead, inserted into the abdomen through a small incision and deployed using cameras.

Mesh isn’t new. It’s been used in hernia repairs for years. And there is this handy little loophole known as the 501(k) that allows a medical device manufacturer to bypass the lengthy and expensive clinical trial process if the new product is substantially similar to that already successfully marketed.

Most health critics blame the 510(k) as the true demon behind prematurely failing knee and hip implants, pacemaker heart leads, and now transvaginal mesh.

Advocates of the 501(k) process claim it gets new and promising products to market faster, thereby benefitting a greater number of patients in need of such new and promising technology.

But as writer Jane Mundy pointed out last year, 501(k) even allows for a product based on an earlier recalled product to be sold without the normal battery of testing required of a bonefide new product. And instead of a finite group of patients who have willingly volunteered to serve as study participants, new products that bear little resemblance to existing devices are in effect live-tested with an entire population serving as guinea pigs.

According to Mundy, Representative Edward Markey introduced legislation in an attempt to repeal the 501(k) loophole, which many view as a flawed process. It failed to gain the necessary support. The Bill died, and the matter was referred to Committee for further study.

Did the Markey initiative fail because too many pharmaceutical and medical device manufacturers have the ear of congressmen? Loss of 501(k) would substantially increase costs for manufacturers in terms of clinical trials, and severely delay introduction of new products to the market. For the pharmaceutical and device manufacturer, the 501(k) is a gift no one wants to lose.

It leaves Americans wondering what’s more important: safety or profits? The FDA is caught in the middle. Lacking teeth, under-staffed and under-funded, the FDA is far from the food, pharmaceutical and medical device police. At best, the FDA serves as the hall monitor. And for the pharmaceutical giants, a lawsuit simply appears to be the cost of doing business.

Gross v. Gynecare Inc., Atl-L-6966-10, (Superior Court of Atlantic County, New Jersey) resulted in an order to Johnson & Johnson to pay $3.35 million in compensatory damages and $7.76 million for punitive damages.


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