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Made of synthetic materials (most often non-absorbable synthetic polypropylene), the mesh is implanted to provide support to prolapsed pelvic organs, a weakened vaginal wall, or to the urethra.
Transvaginal Mesh Risks
Potential side effects are diverse and potentially severe: pain, infection, bleeding, and urinary problems, as well as bowel, bladder and blood vessel perforations.
The most common reported side effect for POP patients—occurring in 10% of patients within a year of implantation, according to numerous studies—is erosion of the mesh through the vaginal wall, a debilitating complication that can require multiple revision surgeries and potentially leave patients with fragments of the mesh embedded in their organs. Seven deaths related to transvaginal mesh POP repairs were reported to the FDA between 2008 and 2010.
FDA Approval Process for Mesh Products
Mesh implants have been used since the 1950s for abdominal hernias; in the 1970s gynecologists began repurposing abdominal mesh products for treatment of POP and, in the 1990s, SUI, prompting manufacturers to create mesh and kits specifically designed for those purposes and marketed directly to gynecologists, rather than surgeons.
The FDA does not require clinical trials for medical implants if the device is similar to one already on the market; devices are cleared rather than approved. This ostensibly allows companies to make incremental changes to their devices without needing to go through a lengthy approval process for each minor change. In practice, it means that medical devices can be put on the market without undergoing human testing, based on a similarity to a single existing device which itself may not have been properly tested.
Protogen Recall & Subsequent Models
Boston Scientific Corporation’s ProteGen device, released in 1996, was the first SUI transvaginal mesh implant cleared by the FDA. However, BSC voluntarily recalled its device less than three years after its introduction due to its severe side effects, high failure rate and frequency of revision surgeries.
Many subsequent transvaginal mesh implants, including a number of models on the market today, are based on the ProteGen’s original, recalled design. In spite of this, a general recall for the devices has not been ordered.
Johnson & Johnson Withdrawal, Not Recall
In 2012, Johnson & Johnson’s Ethicon division pulled four surgical mesh products (Gynecare TVT Secur system, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M) from the shelves. The company, which is facing more than 10,000 lawsuits over the implants, denied that the move was a recall or based on safety concerns, instead blaming it on market factors.
FDA Safety Alert & Continuing Studies
In 2008 the FDA issued a safety alert for transvaginal mesh implants. In 2011, it updated the alert to state that the frequency of adverse side effects to the implants was “not rare,” a more urgent warning than in the initial communication. The agency had seen a significant increase in adverse event reports since the 2008 safety alert.
In 2012, the agency ordered transvaginal mesh manufacturers to conduct further research to determine the safety of the products. In all, nearly a hundred postmarket study orders, known as 522 studies, were directed at 33 manufacturers of POP mesh and seven manufacturers of SUI mesh.
In 2016, the FDA ordered transvaginal mesh products reclassified as Class III devices. The Class III designation indicates that a medical device is considered high risk. Previously, transvaginal mesh bore a Class II designation, signifying only moderate risk. At the same time the FDA ordered this reclassification, the agency also began requiring transvaginal mesh manufacturers to submit a premarket approval (PMA) application to support their products’ safety and effectiveness. The manufacturers also were directed to continue postmarket surveillance studies to address specific safety and effectiveness concerns.
Women Harmed by Mesh File Lawsuits
As of 2013, manufacturers of POP and SUI mesh implants were facing tens of thousands of lawsuits from women harmed by the devices. Some mesh manufacturers have quietly withdrawn their products from the market in the United States in response to the suits. Bard, for example, did so with its Avaulta Plus, though the device remains available outside of the United States.
Meier, B. (2012, January 5). F.D.A. orders surgical mesh makers to study risks. The New York Times. Retrieved December 12, 2013.
- Feeley, J. and Voreacos, D. (2013, September 30). Bard, vaginal-mesh makers, said to be in settlement talks. Bloomberg News. Retrieved December 12, 2013.
- Zimmerman, R. (2011, November 4). Surgery under scrutiny: What went wrong with vaginal mesh. WBUR. Retrieved December 12, 2013.
- Thomas, K. (2012, June 6). Johnson & Johnson unit to halt urinary implants. The New York Times. Retrieved December 12, 2013.
- Voreacos, D. and Nussbaum, A. (2012, March 21). J&J marketed vaginal mesh implant without U.S. approval. Bloomberg News. Retrieved December 12, 2013.
- Feeley, J. (2013, August 13). Bard put profits ahead of patients’ safety, lawyer says. Bloomberg News. Retrieved December 12, 2013.
- Edelhart, C. (2012, July 23). Bakersfield woman wins $3.6 million in first of trials related to medical device. The Bakersfield Californian. Retrieved December 12, 2013
- U.S. Food and Drug Administration. (2013, March 27). Urogynecologic surgical mesh implants. Retrieved December 13, 2013.
- U.S. Food and Drug Administration. (2011, July 13) FDA safety communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Retrieved December 13, 2013.