Transvaginal mesh products are sometimes used during hernia surgery or to repair pelvic organ prolapse or stress urinary incontinence. The U.S. Food and Drug Administration approved the first mesh product, the ProteGen, for SUI in 1996. That product was later recalled, but the FDA approved several additional products based on the first product’s design. The first mesh product for POP was approved in 2002.
Transvaginal mesh implants were so flawed that more than 100,000 women filed lawsuits against the manufacturers after experiencing complications, such as mesh erosion, organ perforation and infection. The FDA issued numerous safety notices about the products, and the agency reclassified mesh implants as high risk. But the FDA says it hasn’t received enough data to warrant a full recall.
Although some companies discontinued the products as more people filed lawsuits, the mesh manufacturers named in the complaints never issued recalls of their devices.
Years after mesh implants made headlines for causing high rates of life-changing complications, consumer advocates and are still calling for the medical devices to be recalled and banned. Many nonprofit groups have advocated for legislation to prevent injury to more women in the future, but the devices remain on the market.
Boston Scientific Recall of ProteGen Mesh
Boston Scientific’s ProteGen was the first transvaginal mesh product on the market. In 1999, three years after it was launched, Boston Scientific recalled the ProteGen because of safety concerns.
A small study of 34 patients who received the ProteGen found that 50 percent experienced vaginal erosion. Seventeen percent developed a urethrovaginal fistula, an abnormal connection between the urethra and the vagina.
In the recall notice, Boston Scientific stated: “Use of the ProteGen in the treatment of female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”
But other manufacturers created their own transvaginal mesh products based on the ProteGen’s design. Because of the similarities between the products and ProteGen, companies were allowed to bypass several clinical trial requirements by utilizing the FDA’s 510(k) clearance program.
The 510(k) program allows medical manufacturers to avoid human testing and deliver a product directly to the market if it is similar to an already approved product. The ProteGen recall didn’t affect the approval status of other devices.
FDA Safety Notices, Warnings and Surveillance Orders
The FDA was slow to act on evidence that transvaginal mesh products were causing dangerous complications in women. The agency first began receiving reports that mesh implants were causing unexpected side effects in 2005. It didn’t reclassify the products as “high risk” until 2016. During the decade before it reclassified the products, the FDA issued a handful of safety notices and convened one committee meeting.
Public Health Notification in 2008
On October 20, 2008, the FDA notified the public of severe complications caused by transvaginal mesh. From 2005 to 2007, the agency had received more than 1,000 reports of adverse events associated with mesh.
The FDA advised physicians to monitor patients for adverse reactions, inform patients of the risks associated with the surgery and to undergo training to learn to implant the devices. Patients were advised that mesh was a permanent implant and some complications could be permanent.
Updated Safety Communication in 2011
Three years later, the FDA reiterated the recommendations that it made in 2008. But it updated its language to state that major complications were “not rare.” It also stated that mesh was not more effective than traditional treatments, such as Burch colposuspension, and mesh may expose patients to greater risks.
From 2008 to 2010, the FDA had received almost 3,000 reports of complications caused by mesh, including 1,503 associated with pelvic organ prolapse surgery and 1,371 associated with stress urinary incontinence procedures.
The FDA announced that it would form a committee to discuss and analyze the risks associated with transvaginal mesh, consider regulations for existing mesh implants and monitor adverse events caused by the device.
Advisory Committee Meeting
In September 2011, the FDA convened an advisory committee on the safety of transvaginal mesh devices. The 15-person panel received comments from medical professionals and patients.
Dr. Michael Carome, then deputy director of Public Citizen’s Health Research Group, urged the committee to recommend a recall of the device. According to Public Citizen, mesh poses significant risks to the public. The group petitioned the FDA to ban the device. It said mesh implants were inadequately tested before being released to the public, and the FDA should require further testing of mesh products.
“Given the absence of evidence for clinically significant benefit and the overwhelming evidence of very serious, common risks, use of synthetic surgical mesh products for transvaginal repair of POP is not ethically justifiable,” Carome said.
The panel refused to recommend a recall, but it recommended reclassifying transvaginal mesh as a class III device. The classification would require products to pass stringent premarket tests before being marketed.
Postmarket Surveillance Orders
In January 2012, the FDA began ordering transvaginal mesh makers to study the safety and effectiveness of their devices. The studies were part of an FDA program called the 522 Postmarket Surveillance Studies Program. Section 522 of the Food, Drug, and Cosmetic Act gives the FDA the authority to order companies to study class II and class III devices. Transvaginal mesh devices were class II at the time.
By February 2013, 34 manufacturers were ordered to study 95 mesh implants designed for use during pelvic organ prolapse surgery. The FDA also ordered seven companies to study 14 bladder slings that were used during stress urinary incontinence surgery.
Reclassifying Transvaginal Mesh to Class III High-Risk Devices
In April 2014, the FDA submitted two proposals to reclassify transvaginal mesh. In January 2016, the FDA finalized those orders.
The first order reclassified transvaginal mesh for pelvic organ prolapse surgery as a class III device. The second order required companies to submit a premarket approval application to support the use of mesh during pelvic organ prolapse surgery.
The orders did not apply to mesh used during stress urinary incontinence surgery. The companies have until July 2018 to submit premarket approval applications.
Companies that Discontinued Mesh Products
Several companies have voluntarily withdrawn products from the market without issuing recalls. When a company withdraws a medical device, it stops selling it. When it recalls a medical device, it warns the public of risks and usually pays for any complications and surgeries associated with the removal of the device.
Mentor Corporation’s Withdraws ObTape
Mentor Corporation’s ObTape Vaginal Sling was a piece of mesh called a bladder sling used to treat incontinence in women. Its design was based on Boston Scientific’s recalled ProteGen sling. ObTape was implanted between 2003 and 2006 before its manufacturer withdrew it.
About 35,000 women received the implant. One of the biggest problems with the product was a high rate of vaginal erosion, and many doctors stopped using the product before it was discontinued. Experts claimed the product was too dense and did not allow capillaries and tissue to grow through it, causing the body to reject it.
Ethicon Pulls Mesh Products
In June 2012, Johnson & Johnson’s Ethicon unit stopped selling four of its Gynecare mesh products after more than 600 women filed lawsuits against the mesh manufacturer.
The following products were discontinued:
- Gynecare Prolift Kit
- Gynecare Prolift + M Kit
- Gynecare TVT Secur
- Gynecare Prosima Pelvic Floor Repair System Kit
The company stopped selling the products worldwide, but it didn’t recall mesh that was already sold or implanted. The company stated that safety was not the reason it discontinued the devices. Ethicon continues to sell Gynecare Gynemesh, but the company changed the labeling to restrict its use to abdominal implantation.
Transvaginal mesh has been linked to a high rate of complications. The FDA classifies the device as “high risk.” The agency has stated that the device is not more effective than other treatments for prolapse or incontinence. Despite requests from numerous public safety organizations and evidence of complications in thousands of women, the FDA has not issued a recall of the devices.