Despite thousands of lawsuits and growing public concern surrounding the use of transvaginal mesh in pelvic surgery, many mesh products are still available on the market. These products are known to cause life-altering and potentially fatal complications, including vaginal erosion, organ perforation, infection, and nerve damage.
A number of mesh devices have been voluntarily recalled or withdrawn by their manufacturers. Various health associations and consumer groups have put pressure on the U.S. Food & Drug Administration (FDA) to issue a complete recall of transvaginal mesh products. But at this time, the FDA is unwilling to meet this demand.
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Why Were Unsafe Transvaginal Mesh Products Sold?
After mesh implants proved effective in abdominal hernia repair, the FDA approved more than 60 similar devices for use in pelvic surgery. This was done under an exemption process known as 510(k) exempt that allowed the products to go to market without requiring prior review from the agency.
The first transvaginal mesh product for use in treating stress urinary incontinence (SUI) was approved in 1996. Amidst immediate reports of serious complications, it was recalled in 1999 (just three years later), but this was too late: Its availability had already set a precedent and a pathway for dozens of similar (and similarly flawed) products. By the early 2000s, mesh implants were commonplace medical devices supporting SUI and pelvic organ prolapse (POP) surgeries across the U.S.
FDA Guidance on Surveillance of Medical Devices FDA Issues New Rules For Monitoring Implanted Medical Devices
At the time, the FDA didn’t require human clinical trials or long-term data prior to approval. In the years that followed, hundreds of thousands of women received transvaginal mesh implants. The majority didn’t know about the risks–some weren’t even told that mesh would be used in their surgeries. Clearly, this gave rise to widespread damage–and multiple legal actions.
FDA Actions Concerning Transvaginal Mesh
Below is a timeline of significant actions taken by the FDA in response to reports of serious complications caused by transvaginal mesh:
October 20, 2008
The agency issues a Public Health Notification to doctors, alerting them to the potential risks of using transvaginal mesh in pelvic surgeries. The notification states that the FDA received more than 1,000 reports of transvaginal mesh complication in POP and SUI patients between 2005 and 2007.
July 13, 2011
The agency issues a safety communication titled “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.” In the communication, the agency states that “complications associated with transvaginal repair of POP are not rare.” It is also noted that transvaginal mesh implants pose a greater risk to POP patients than traditional non-mesh surgery, and that it is unclear whether mesh surgeries are more effective.
May 1, 2014
To address growing safety concerns, the agency proposes reclassifying transvaginal mesh devices for POP surgery from class II to class III (the highest risk level for medical devices). It also proposes reclassifying surgical tools that will be used in transvaginal mesh surgeries from class I to class II.
January 5, 2016
Transvaginal mesh devices are reclassified as class III medical devices. As a result, all new products will require premarket approval before they can be sold.
February 26, 2016
A panel is held to discuss the reclassification of surgical tools for use in vaginal mesh surgeries.
January 6, 2017
Surgical tools for use in vaginal mesh surgeries are reclassified from class I to class II (special controls). This reclassification means that companies are required to give the FDA premarket notification before they can sell surgical instruments of this nature.
Transvaginal Mesh Recalls and Withdrawals
Although the FDA has admitted that serious complications resulting from transvaginal mesh implants are not rare, the agency has stopped short of issuing a complete recall of vaginal mesh products.
On September 27, 2011, a representative of the National Research Center for Women & Families gave testimony at an FDA meeting on pelvic mesh and called for a recall of vaginal mesh devices. Their voice joined dozens of likeminded medical and nonprofit health organizations arguing that the proven dangers of vaginal mesh outweigh any potential benefits.
Several vaginal mesh products have been recalled or withdrawn from the market by their manufacturers – potentially as a result of the high volume of lawsuits resulting from mesh complications.
Boston Scientific ProteGen Sling
The ProteGen Sling was the first vaginal mesh device that the FDA cleared for sale. It was released in 1996 for use in SUI surgeries, but within a period of months, reports of serious complications began to surface. Boston Scientific voluntarily recalled their product in 1999. But this recall came after numerous similar products used the ProteGen Sling’s approval for sale as a pathway for their own clearance. Many of these products are still on the market.
Mentor’s ObTape vaginal sling
In March 2007, the OpTape vaginal sling was discontinued by its manufacturer, Mentor. Despite this, Mentor did not withdraw OpTape products that were already for sale, meaning some continued to be used in pelvic surgeries.
C.R. Bard’s Avaulta Plus, Pelvilace, and Uretex
C. R. Bard have withdrawn three transvaginal mesh products in response to calls for additional testing. These products are:
- Avaulta Plus
- Ethicon’s Gynecare range (partial)
In 2012, Johnson & Johnson’s Ethicon division withdrew four of its Gynecare mesh products from the market. These products are:
- Gynecare Prolift Kit
- Gynecare Prolift + M Kit
- Gynecare TVT Secur
- Gynecare Prosima Pelvic Floor Repair System Kit
Ethicon did not cite safety concerns as the reason for this withdrawal, and continues to sell some Gynecare brand mesh devices, although their labels have been updated to state they are only for use in abdominal (and not vaginal) surgeries.
Endo (all vaginal mesh products)
In 2016, Endo International announced it was closing its Astora Women’s Health division, which was responsible for the production of all transvaginal mesh products sold by the company. This decision came after Endo was forced to set aside billions of dollars to handle potential litigation resulting from faulty mesh products.
These recalled and withdrawn products represent only a fraction of the vaginal mesh products approved for sale. Many are still available, although the FDA discourages doctors from using them in pelvic surgeries.
If you or someone you know requires surgery to correct POP or SUI, speak to your doctor to ensure vaginal mesh will not be used in your surgery.