Breaking News: FDA Reclassifies Transvaginal mesh Products as High Risk

On April 29, 2014, the FDA announced that after careful consideration, surgical mesh products utilized for “Pelvic Organ Prolapse” (POP) would be reclassified from a moderate-risk device (class II) to a high-risk device (class III). This new development means that manufacturers will now be required to submit a premarket approval (PMA) application for the agency to evaluate the safety and efficacy of the products.

William Maisel, the chief scientist at the FDA’s Center for Devices and Radiological Health, stated, “the FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapsed and is now proposing to address those risks for more safe and effective products.”

This decision by the FDA comes as no surprise given that there has been a 70% decline in sales of transvaginal mesh products since July 2011. In January 2012, the FDA issues 522 orders requiring postmarket surveillance for all manufacturers of pelvic organ prolapse mesh products.

While this is a step in the right direction, it is disturbing that many of the transvaginal mesh products were based on a recalled device. Over the past few years, there has been significant pressure for the FDA to change its 510(k) medical device approval process. This process permits manufacturers to submit documentation for approval of a new device by demonstrating that it is “substantially equivalent” to a predicate device or a device already on the market. The 510(k) process does not require evidence of clinical safety or efficacy.

In 1996, Boston Scientific’s ProteGen sling was approved by the FDA. After only three years on the market, the ProteGen sling was recalled by Boston Scientific citing adverse events including pain, infections, erosion and migration. It is estimated that almost 20,000 ProteGen mesh products were recalled.

Once ProteGen was cleared for use by the FDA, several other manufacturers based their 510(k) application on the ProteGen sling including In-Sling manufactured by Influence, Inc, Gynecare Tension-free Transvaginal Taping (TVT) by Ethicon, a subsidiary of Johnson & Johnson and the ObTape by Mentor Corporation. The ObTape product was recalled in 2006 and in June 2012, Johnson & Johnson’s Ethicon division announced that it would stop selling fourtypes of mesh implants, Gynecare TVT Secur System, GynecareProsima Pelvic FloorRepair System, GynecareProlift Pelvic Floor Repair System, and GynecareProlift+MPelvic Floor Repair System, used to treat stress urinary incontinence.

One of the main things that these products have in common is the fact that the 510(k) applications were based on a recalled device. Additionally, products from several other manufacturers including AMS and Tyco have been indirectly predicated on the Protegen Sling. At no point, were these manufacturers required to conduct clinical testing or re-assure the FDA and the public that their products were safe despite being based on a recalled product.

Between 2005 and 2010, the FDA received almost 4,000 adverse event reports concerning problems with transvaginal mesh products. From the reports provided to the FDA, approximately 35.1% of those include erosion for pelvic organ prolapse products. Dr. Thomas Margolis, a pelvic surgeon in California, recently told Bloomberg, “The FDA got caught with their pants down, the ProteGen should have told them, ‘wait a minute, all these mesh systems are bad.’”

The decision by the FDA to reclassify the transvaginal mesh products as “high risk products” is a confirmation of the inherent danger of these products. Countless women have suffered from pain during intercourse, pelvic pain, recurrent infections, mesh erosion, mesh extrusion and several surgeries to remove the mesh.

Pierce | Skrabanek PLLC

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