Why did the FDA issue warnings for transvaginal mesh?
Surgical mesh has been used since the 1960s for gynecologic and urologic surgical procedures, but the first product marketed for use in transvaginal procedures was not introduced until 1996. It was approved under the FDA’s 510(k) shortcut process which does not require clinical testing for medical devices that are claimed to be similar to other devices already in use.
By 2008, an alarming number of complaints had been reported to the FDA regarding complications caused by vaginal mesh and a safety alert regarding its use was issued. Between 2008 and 2011, the FDA collected more than 3,000 reports of serious adverse events related to the use of transvaginal mesh prompting the issuance of additional warnings.
In 2012, the FDA required manufacturers of 34 POP and 7 SUI mesh products to conduct safety studies for their devices. The agency also conducted an exhaustive literature review, examining documented clinical and anecdotal evidence of comparison of safety and success of POP and SUI procedures where transvaginal mesh was used in comparison to procedures performed without mesh..
The FDA’s safety review concluded that when compared to non-mesh procedures, placement of transvaginal mesh in surgical procedures showed:
- Transvaginal mesh was not always better at treating symptoms or improving quality of life
- Transvaginal mesh may introduce problems not present in traditional non-mesh surgeries
- Transvaginal mesh may have greater risks than abdominally transplanted mesh
- No evidence that using mesh to reinforce the top of the vagina or the back wall of the vagina resulted in better outcome
- Transvaginal mesh may present a previously unknown risk, called mesh contraction, which in vaginal shortening, vaginal tightening, and vaginal pain
- Mesh erosion is the most common complication arising from transvaginal mesh surgery to treat POP
In 2016, the FDA required a change to the approval process for transvaginal mesh and began requiring clinical studies for new products, however products already approved may not have been subjected to the same rigorous guidelines. To date, though hundreds of thousands of women may have been harmed or may still be at risk, the FDA has not demanded the removal of transvaginal mesh from the market
What transvaginal mesh products have been recalled or discontinued?
Despite the number of injuries that have been reported for transvaginal mesh products, no large-scale recall has been issued by the FDA. Some manufacturers have voluntarily withdrawn their products, but many still remain on the market.
Notable voluntary recalls include:
Boston Scientific introduced one of the first transvaginal repair products, which also had some of the highest failure rates. Boston Scientific’s ProtoGen transvaginal mesh was voluntarily recalled in 1999, followed by ObTape’s recall in 2006. These products were replaced by newer versions which have also caused injuries.
C.R. Bard voluntarily recalled and discontinued manufacturing their Avaulta Plus transvaginal mesh in 2012, after a jury awarded more than $5 million to a woman who had been harmed by the device. Bard still manufactures a number of other transvaginal products however and is facing multiple lawsuits.
Ethicon, a division of the medical giant Johnson & Johnson, recalled and withdrew transvaginal mesh products in the GyneCare line. The GyneCare line was renamed and re-marketed them to be used in abdominal surgeries only but the company still manufactures other transvaginal products and faces thousands of lawsuits for transvaginal mesh and other surgical mesh devices.