A few weeks ago we explored the 510(k) process through which medical devices are approved based on similarities to a predicate (older device). In the last post, the problems with the 510(k) process were expounded upon when we discussed SOUND Device Act’s attempt to empower the FDA to actually provide protection from faulty medical devices. The current language of the law prevents the FDA from denying the application of 510(k) devices even when their grandparent devices were problematic and even harmful.
Today’s dangerous transvaginal mesh products used Boston Scientific’s ProteGen Sling as their 510(k) predicate device to force the FDA’s approval. Considering the history of the ProteGen Sling, the issues with transvaginal mesh (TVM) should have been as predictable as they are tragic.
Embarrassing Family History
Here is a quick timeline of the short-lived predicate device, the ProteGen Sling.
- 1995: Boston Scientific seeks 510(k) approval for a synthetic sling to treat urinary stress incontinence. They cite the use of the fabric for cardiovascular grafts as well as in a 90-day rat study. The material has never before been used in urological operations.
- November 15, 1996: The FDA grants approval of the sling, despite no human testing demonstrating its efficacy and safety.
- April 1997: The ProteGen Sling is unveiled at the American Urological Association’s spring convention. By this point, the device has already been on the market for a few months.
Immediately upon its introduction, troubling reports start to roll into Boston Scientific about the Protegen. In the first 9 months, Boston Scientific reports 56 adverse events to the FDA and an additional 57 during the following 6 months.
- June 1998: The FDA inspects one of the ProteGen Sling plants. The results are far from comforting, as they discover that Boston Scientific has reported only the cases in which the sling had to be removed (not all other complications) and that 30 percent of complaints made have simply not been reported.
Although the number of complications and serious adverse events were high, the FDA does not move to recall the product.
- Jan. 22, 1999: Six months after the FDA inspection, Boston Scientific officially recalls the ProteGen Sling.
In a short 22 months, over 17,000 women received the implanted device.
Progeny of the ProteGen Sling
Although the ProteGen Sling was on the market short of two years, the affair lasted long enough for Johnson & Johnson to use it as the 510(k) predicate for its own bladder sling, the Gynecare TVT, which was approved by the FDA in 1998.
From ProteGen, a device that itself slipped through the cracks of the 510(k) system, came a whole family of bladder slings, which in turn spawned transvaginal mesh for pelvic organ prolapse repair. The fruits of this family? Thousands of women who suffer daily, have undergone multiple painful surgeries to varying degrees of success and who are in no better, and in many cases far worse, condition than they were before their TVM implant.
Where Does it Stop?
Manufacturers have been knowingly modeling mesh devices after faulty products for over a decade. They continue with product development and marketing without addressing these serious safety issues, despite the constant influx of tragic stories of lives ruined by TVM. Why? Perhaps because they can.
The FDA cannot deny the 510(k) requests and has not issued official recalls of TVM devices. Thousands of women and their families, however, have begun to speak out and take TVM manufacturers to court to hold them responsible for the damage done by their products. Get the word out: Share this blog; tell your story; demand justice.