Transvaginal Mesh Recall, FDA Ban and Discontinued Products

The U.S. Food and Drug Administration cleared the first mesh product, the ProteGen Sling, for stress urinary incontinence (SUI) in 1996. Boston Scientific recalled the product about three years later.

However, before the product left the market, the FDA cleared several additional products based on the ProteGen Sling’s design.

Over the last decade, the FDA has issued safety notices, convened advisory committees and ordered manufacturers to stop selling surgical mesh for certain transvaginal repairs after reclassifying the medical devices as “high-risk.”

More than 100,000 women have filed transvaginal mesh lawsuits against the manufacturers after experiencing complications, such as mesh erosion, organ perforation and infection.

Although other mesh manufacturers have discontinued their products, they’ve never issued recalls of their devices.

In 2019, the FDA banned transvaginal mesh for treating pelvic organ prolapse. Then, in October 2022, the FDA reaffirmed that transvaginal placement of surgical mesh to treat POP doesn’t outweigh the risks.

POP is a condition that occurs when the pelvic floor weakens and allows organs, such as the bladder or bowel, to shift and sag out of place into the vagina. Transvaginal POP repair is a surgical procedure that goes through the vagina. While the FDA banned transvaginal POP repair, patients can still have POP repair with mesh placed through the abdomen.

The ProteGen Sling is the only transvaginal mesh product that has been formally recalled. Its manufacturer, Boston Scientific, recalled the device in 1999 after studies found high rates of vaginal erosion and infection.

The recall did not affect the approval status of other mesh products, which were later withdrawn voluntarily by manufacturers or ordered off the market by the FDA. These actions are legally distinct from a recall.

A small 1999 study published in The Journal of Urology found high rates of erosion, infection and pain with the device. To conduct the study, researchers with Cedars-Sinai Medical Center in Los Angeles reviewed records of patients who had their ProteGen Sling removed at five centers over the course of two years.

Half of the 34 patients who had their ProteGen Sling removed suffered vaginal erosion. Seventeen percent developed a urethrovaginal fistula, an abnormal connection between the urethra and the vagina.

“The FDA found that the product was associated with a ‘higher than expected rate of vaginal erosion and dehiscence’ and did ‘not appear to function as intended,’” Dr. L. Lewis Wall and Douglas Brown wrote in a 2010 article in the American Journal of Obstetrics & Gynecology.

Prior to entering the market, the mesh sling did not undergo controlled clinical trials, and researchers had never implanted it in a human vagina.

“Boston Scientific relied on a 90-day study in rats and the fact that the mesh was already being used for cardiovascular grafting to gain approval from the FDA,” according to Wall and Brown. “The results were disastrous.”

Before the product was recalled, other manufacturers created their own transvaginal mesh products based on ProteGen’s design through the 510(k) clearance process. This allowed them to bypass some clinical trial requirements. According to research published in BMJ, manufacturers brought at least 61 mesh implants to market through this process.

The FDA issued its first public health notification about transvaginal mesh in 2008. It updated its safety communication in 2011 to tell patients that complications were “not rare.”

In 2016, the agency reclassified POP mesh as a Class III high-risk device. A few years later, manufacturers were ordered to stop selling transvaginal mesh for pelvic organ prolapse in April 2019.

Abdominal SUI and POP mesh implants are still available. The FDA also hasn’t updated its regulation of mesh products since 2024.

2008: FDA Issues First Public Health Notification on Mesh Complications

On Oct. 20, 2008, the FDA notified the public of severe complications caused by transvaginal mesh. From 2005 to 2007, the agency received more than 1,000 reports of adverse events associated with mesh, according to an article by Dr. Toyohiko Watanabe and Dr. Michael B. Chancellor in Reviews in Urology.

In 2010, roughly 75,000 women underwent transvaginal POP surgeries with mesh in the United States. Additionally, more than 200,000 women received a mesh implant to treat SUI, according to the FDA. From January 2008 through December 2010, the agency received an additional 2,874 adverse event reports associated with mesh used in POP or SUI repair.

The FDA advised physicians to monitor patients for adverse reactions and inform them of the risks associated with the surgery. Doctors were also advised to undergo training to learn to implant the devices.

July 2011: FDA Updates Safety Communication

In a 2011 Safety Communication, the FDA reiterated the recommendations it had made in 2008. But it updated its language to state that major complications are “not rare.”

The agency said it had not found conclusive evidence that using transvaginally placed mesh improves clinical outcomes any more than traditional non-mesh treatments, and it may expose patients to greater risks.

The FDA announced that it would form a committee to review and analyze data on the safety and effectiveness of transvaginal mesh and provide recommendations to the agency.

September 2011: FDA Advisory Committee Recommends Class III Reclassification

In September 2011, the FDA convened an advisory committee on the safety and effectiveness of transvaginal mesh devices. The 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 had petitioned the FDA to ban the device. It said that mesh implants were inadequately tested before being released to the public and that 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 in his testimony.

The panel refused to recommend a recall, but it recommended reclassifying transvaginal mesh as a Class III device. The classification requires products to pass stringent tests before they can be marketed.

2012-2013: FDA Orders Postmarket Safety Studies for Mesh Manufacturers

In January 2012, the FDA ordered mesh manufacturers 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, the agency had ordered 34 manufacturers to study 95 mesh implants designed for use during pelvic organ prolapse surgery. The FDA also ordered seven companies to study 14 bladder slings indicated for the treatment of stress urinary incontinence.

2016: FDA Reclassifies Transvaginal POP Mesh as Class III High-Risk Device

In April 2014, the FDA submitted two proposals to reclassify transvaginal POP mesh. It finalized the proposed orders in 2016, and in January 2017, the FDA issued the final order.

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 POP surgery.

The orders did not apply to mesh products used during stress urinary incontinence surgery. The companies were given until July 2018 to submit premarket approval applications.

Instead, most manufacturers stopped selling their transvaginal mesh devices for POP. In April 2019, the FDA ordered the remaining companies to stop marketing the products.

2019: FDA Orders Manufacturers to Stop Selling Transvaginal POP Mesh

On Feb. 12, 2019, the FDA held another advisory committee meeting to review the safety and effectiveness of mesh for transvaginal repair of prolapse.

To demonstrate that the mesh was safe and effective, manufacturers had to show it was superior to native tissue repair at 36 months and that safety outcomes were comparable.

Boston Scientific and Coloplast were unable to provide adequate data to the FDA. The agency ordered them and other manufacturers to stop selling transvaginal mesh for pelvic organ prolapse on April 16, 2019.

2024: Final Results of the 522 Studies for SUI Mini-Slings

In April 2024, the FDA released the results of its review of the 522 studies on SUI mini-slings. The agency found SUI mini-slings were as effective as traditional mid-urethral slings over a 36-month timeframe, but it didn’t mention anything about safety risks. The FDA said it would continue to request a 522 study for any mini-sling with a novel design that hits the market.

Several companies have voluntarily withdrawn products from the market without issuing recalls. When a company withdraws a medical device, it stops selling the product. When a company recalls a medical device, it warns the public of the risks and usually pays for any complications and surgeries associated with the device’s removal.

The FDA can also order companies to stop selling a product. An example of this is when the agency told Boston Scientific and Coloplast to stop selling their transvaginal mesh products.

Mentor Corporation Withdraws ObTape

Mentor Corporation’s ObTape Vaginal Sling was a mesh device used to treat incontinence in women.

To get clearance to sell its device, Mentor told the FDA the product was essentially the same as Johnson & Johnson’s Tension Free Vaginal Tape System, which had been cleared based on claims it was much like Boston Scientific’s recalled ProteGen Sling.

Surgeons implanted ObTape between 2003 and 2006 before its manufacturer withdrew it.

One of the biggest problems with the product was a high rate of vaginal extrusion. Some 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.

The company stopped selling these products worldwide, but it didn’t recall the mesh that had already been sold or implanted. The company also 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.

Other Discontinued Devices

Rather than provide the FDA with new safety data, several companies discontinued their devices.

Manufacturers brought at least 61 mesh implants to market through the 510(k) clearance process by referencing Ethicon’s Mersilene Mesh and Boston Scientific’s ProteGen Sling.