October 8th 2012 4:00pm
Over eight years ago, a disaster was born. This device and its progeny would go on to cripple millions of women across the United States. The device is called the Perigee System, manufactured by American Medical Systems (AMS). The Perigee System is a palm-sized piece of polypropylene mesh affixed to four plastic “arms” designed to correct anterior pelvic organ prolapse in women (the sister device, the Apogee System, corrects posterior prolapse). It comes pre-packaged in a box along with curved “trocars” that eerily resemble the metal hooks used by butchers in the meat industry. The doctor opens the package and begins the procedure by making multiple incisions in the woman’s pelvic region, and using the trocars to drive the arms of the product through the pelvic region and into the vaginal cavity. The end result is that the woman’s vaginal compartment is lined with polypropylene mesh that is “anchored” to her ligaments. Later, the mesh reacts to the body and incites a “shrinkage” response coupled with a host of other problems resulting in physiological ailments such as nerve damage and chronic fibrosis which results in permanent, crippling damage to the pelvic region.
The FDA never required safety or efficacy studies to be conducted on this device, but instead allowed the device to be cleared through the 510(k) process. The 510(k) process allows a product to be “cleared” for immediate marketing so long as the manufacturer submits that the device is “substantially equivalent” to device(s) currently on the market. The AMS Perigee 510(K) summary is a real eye-opener of the leniency of the FDA (Perigee is 510(k) summary no. K040623). The Perigee was genuinely a first-of-its-kind product, so to get the 510(k) application to work, AMS had to “Frankenstein” something together. AMS used three currently-existing stress urinary incontinence sling systems (small strips of mesh that are surgically placed under the urethra) and simple polypropylene sheet mesh as the “predicate devices” in which it relied upon for clearance. The FDA rubber-stamped the product, and “Pelvic Organ Prolapse Kits” were born. Other manufacturers quickly joined suit and began packaging and marketing kits for mass-production and distribution all over the country.
Since these products were released onto the market, more than (an estimated) 150,000 women have been implanted with this type of device. More than seven years later, the FDA realized that clearing this product may have been a mistake. Last July, the FDA made a public safety announcement regarding the dangers of transvaginal mesh products. Then, last September, the FDA held advisory committee meetings that resulted in the obvious conclusion that these products need more studies. So, where are these studies? One would think they would need to happen pretty quickly and be implemented with rigor to ensure that women do not continue to get hurt, right?
These studies are called 522 Postmarket Surveillance Studies and are implemented when the FDA receives data that indicates that a device is likely harmful and needs to be studied further. There are 295 Postmarket Surveillance Studies currently being implemented by the FDA, almost exclusively involving transvaginal mesh products or hip device components. The running list of 522 studies can be viewed on the FDA’s website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm. The FDA officially ordered these 522 studies in January. The implementation plan and progress for these studies is not easily accessible to the public. The current status of most of these studies is listed as “Plan Overdue” or “Other,” leaving the public to wonder if and when these studies will be conducted and if they will ever produce meaningful results. With the FDA’s attitude of considering “the least burdensome approach in all areas of medical device regulation” (quote from FDA’s 522 Guidance Page), one can only wonder how long this will take and how effective this process will ever be.
Meanwhile, manufacturers are beginning to sweat for other reasons. More than 5,000 transvaginal mesh lawsuits have been filed in federal court; with thousands more in state courts across the country. Rather than follow through with the FDA’s 522 Postmarket Studies, some manufacturers are choosing to simply scrap their products and withdraw them from the market under a silent recall scenario. For example, this past June Johnson & Johnson publicly announced the withdrawal of its Prolift product and its other prolapse and mini-sling transvaginal mesh products. C.R. Bard no longer lists its Avaulta product on its website, indicating another silent recall afoot. It is apparent that much of the pressure is being applied by the legal community seeking civil justice and patient advocate groups demanding answers and a insisting that the FDA do its diligence. Over the past year, the legal and medical communities have become much more enlightened on the dangers of transvaginal mesh. One day, hopefully our regulatory system will reach the same level of enlightenment.
More on Transvaginal Mesh lawsuits.
Robert Price is an associate with the firm of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A. Robert focuses his practice on mass torts and product liability. He is part of the Plaintiffs’ Steering Committee for the Federal Multidistrict Transvaginal Mesh Litigation and is actively involved in leadership in state court mesh litigation in addition to working in other cases involving bad drugs and defective medical devices.