Of the sixty or so pelvic meshes that were or currently are on the market in the United States you may not have heard of the ProteGen mesh, a model designed and manufactured by Boston Scientific. The ProteGen was the first transvaginal mesh approved in the U.S. in November 1996.
It has the distinction of being the “grandmother” or prototype that served as a model for most of the permanently implanted pelvic meshes that followed.
Boston Scientific had beat their competitors in terms of marketing efforts, which were put into play shortly after forecasters predicted the aging baby boomers would be in need of pelvic mesh support to treat prolapse and incontinence post surgery.
In 1996, ProteGen began marketing after being cleared through the Food and Drug Administration’s (FDA) 510(k) premarket notification process as manufacturers file to seek an approval to market and sell, not based on safety or efficacy. The clearance number is #K963226.
The “K” in the clearance number stands for the K in the 510K FDA code that allows for clearance without clinical trials after an exchange of paperwork, the naming of a “predicate device” that is the “substantial equivalent” of the new device, a few thousand dollars and a wait of about 90 days.
The entire process is a significant gesture of the device industry and relies on its honesty and integrity. From what we’ve learned about the thinking of device manufacturers and their rush to get the product on the market, the confidence in the quality of their product is not necessarily warranted.
After November 1996, a flood of new competitor devices made it to market. Ethicon’s Tension Free Transvaginal Tape (TVT) was cleared by the FDA in January 1998 naming ProteGen as a predicate device. The TVT-O (obturator) was also cleared for market based on the ProteGen model.
Altogether dozens of devices named the ProteGen as a predicate. If they were not directly linked, they were predicated on some other devices that were based on ProteGen. Mentor, Ethicon, American Medical Systems, Gyne Ideas, Tyco, Caldera all either named ProteGen as their direct or indirect predicate (substantial equivalent).
All of these pelvic mesh implants were approved through the fast-track 510(k) process with the knowledge that “No performance standards applicable to surgical mesh have been established by the FDA,” as was stated in the 510(k) Summary for the In-Sling
As is the lack of a standardized process for approval isn’t concerning enough, the ProteGen sling, was recalled from the market by Boston Scientific on March 17, 1999 for some troublesome complications.
The reason stated – “The use of the ProteGen in the treatment of female urinary incontinence is associated with a higher rate than expected of vaginal erosion and dehiscence and does not appear to function as intended.” Dehiscence is a wound rupture at a surgical incision. In short, the mesh was recalled after proving to be defective in ways that were harmful to patients.
This recall should have been a huge red flag for the FDA, who’s job through their approval process is keeping Americans safe by ensuring that the process. If a predicate device is defective, those that follow should be carefully inspected for the same issues.
Sort of like the 1977 recall of the Ford Pinto because of its tendency to erupt into fuel-tank fires in rear end collisions. Imagine if there was a family of automobiles based on the Pinto design? Would they be subject to a recall or at least a review to see if they share the same safety deficiencies as the Pinto?
But ProteGen did not set off a different review process for pelvic mesh devices. Even though it was recalled due to it’s harmful effects, there is was no effort within the FDA to more thoroughly inspect the medical devices that were developed based as “substantial equivalents” to the ProteGen.
Even though the ProteGen is history, most of its entire family of successor meshes remain on the market and we know from more than 100-thousand lawsuits what has happened.
For the same reasons that mesh manufacturers are being shunned for discreditable marketing and manufacturing practices, the FDA needs to share in some of the blame.
In 2011, the Institute of Medicine said the now 40-year-old 510(k) approval process is obsolete and needs to be revised in order to provide the assurance of safety and effectiveness of medical devices before they are approved to be used by the public. The Protogen is a perfect example of the need for change.