Mesh-Injured Patient Reserches ProteGen Mesh Predicate

Nov 18th, 2011 | By | Category: Op-Ed

Suzanne McClain

Editors Note* – I first interviewed Suzanne McClain, 45,  in March 2009 and she became part of the series of reports for Injuryboard.com . She is not just a mesh-injured woman but  has spent hours digging into the FDA’s files to research the predicates for the devices currently on the market. McClain was implanted with the Ethicon Transvaginal Tension-Free mesh made by Johnson & Johnson in 2004 to treat stress urinary incontinence. Four years later she knew she had a problem – the mesh had eroded through her vaginal wall and was causing infections. She’s had repeated surgeries to extract the mesh. Her lawsuit case should be heard sometime in early 2012.

Suzanne McClain

“Devices that are to be implanted in one’s body, whether it is a Class II or Class III Device should never be cleared to go to market under the 510K process. Surgical mesh, a Class II device has received clearance using this method, and thousands have been injured. I am merely one of these statistics.

“As a result of suffering these injuries, I began researching many surgical mesh devices cleared by the FDA. I have linked more than sixty of theses clearances, (as late as 2009) to Boston Scientific’s ProteGen Sling that was recalled by its own manufacturer in a letter to the FDA on January 22, 1999. The reason stated in the FDA’s March 17, 1999 Enforcement Report was “Use of the ProteGen in female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”

“These devices are all predicated upon one another, and even though the newer devices had not specifically used the recalled device as their predicate, I was able to link them through devices they used as predicates that were predicated by the ProteGen Sling. Following the FDA mesh clearance merry-go-round is not an easy task; it took me quite some time to master the research process of their website.

“One thing of interest I found was the clearance of the IN-SLING, manufactured by Influence Inc., and cleared by the FDA on September 19, 1997. The approval number is K972651. Within Influence Inc.’s document, under the subheading “Performance Standards” it was clearly stated “No performance standards applicable to surgical mesh have been established by the FDA” yet the FDA approved this device and has subsequently cleared many more surgical mesh devices over the last decade. If, as this document states, no performance standards had been established, neither this device nor its predecessor the ProteGen Sling should have received FDA clearance. Had these clearances not been issued, it would have saved thousands from being injured. The FDA is clearing these devices in a negligent and irresponsible manner predicated on greed.

“We must do away with the pharmaceutical lobbyist and get the pharmaceutical companies, the FDA, the doctors and our elected officials out of bed with each other. Until regulatory agencies in the United States can recognize and rectify these problems, we as a society are doomed to poor health care that’s cost is exorbitant; both in injuries and monetarily, and we as patients are paying the price.”

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2 Comments to “Mesh-Injured Patient Reserches ProteGen Mesh Predicate”

  1. Amy G says:

    Thank you Suzanne and Jane your early efforts certainly helped others who suffer with mesh complications.

  2. Denise says:

    Thank you, Suzanne, for all of your hours spent in research and for sharing your work. Thank you, Jane, for starting MDND and for all of your work informing others about the “mesh mess”.
    The FDA’s 510(k) process using “predicates” is outdated and flawed. It made no sense to “clear”, not “approve”, a device with “no performance standards applicable”. It made even less sense to keep products on the market that used that “predicate” to gain market access after it was removed for being “misbranded and adulterated”. This was all done with NO pre marketing clinical trials! SHAME ON the FDA, the companies marketing these transvaginal mesh devices, and the surgeons who are implanting transvaginal mesh without EVIDENCE BASED CLINICAL SCIENCE….. AHEAD of time!!!

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.