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Transvaginal Mesh Recall

In July of 2011, the Food and Drug Administration issued a safety communication updating its warnings about the dangers of transvaginal mesh products. However, the FDA stopped short of ordering a transvaginal mesh recall; as a result, these products are still sold today by many manufacturers and continue to be used in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

Unfortunately, even as TVM products continue to be used, thousands of lawsuits have been filed against the makers of surgical mesh products because women have experienced many serious complications. Not only that, but a recent study conducted by Georgetown University researchers indicated that patients who have mesh implanted as opposed to more traditional procedures do not generally experience a better outcome despite the added risks associated with surgical mesh.

Amidst the bad news about TVM devices, many transvaginal mesh manufacturers have voluntarily suspended sales of their products, though none have been compelled by the Food and Drug Administration to do so.

Voluntary transvaginal mesh recall

The first of the voluntary surgical mesh recalls actually occurred as far back as 1999, when Boston Scientific pulled its PhotoGen mesh implant from the market just three years after it was initially approved. The product was eliminated from the market when dozens claimed serious injuries and sued.

Despite the fact that Boston Scientific took its PhotoGen product off the market as a result of its dangers, it served as the prototype cited by other manufacturers to obtain approval for many of today’s vaginal mesh devices. Mesh makers have used a special FDA rule called 510(k) clearance when bringing the products to market. Under 510(k) clearance, a health product that is substantially similar to a medical device already on the market can be approved with minimal or no pre-release human testing.

Since the PhotoGen mesh implant was not subject to a mandatory recall, the FDA still allowed manufacturers to use this product as a precursor to bring new surgical mesh implants to the market.

Many second and third generation pelvic mesh products have been linked to serious injuries and complications, and multiple manufacturers have discontinued the sale and marketing of surgical mesh devices.

Examples of medical device manufacturers who have discontinued transvaginal mesh product lines include:

  • Ethicon, a Johnson & Johnson subsidiary, stopped selling certain mesh devices in the summer of 2012. The mesh products that Ethicon took off the market included the Gynecart Prolift kit; the Gynecare TVT Secur, the Gynecare Prosima Pelvic Floor Repair System Kit, and the Gynecare Prolift + M kit.  A spokesperson for Ethicon indicated that the removal of these products from the market was not prompted by safety concerns, and that the company continues to have confidence that its mesh products are safe.
  • C.R. Bard stopped selling the Avaulta Plus surgical mesh product in July of 2012, around four years after the product was first approved by the FDA for the treatment of stress urinary incontinence and pelvic floor disorders.

Even as these mesh products have come off the market, many others remain and continue to be used.  Ethicon continues to sell Gynecare Gynemash, but now restricts that particular product to use in abdominal implantations.

Other major mesh manufacturers include American Medical Systems; Boston Scientific; Coloplast Corp; and Cook Medical.

Serious risks linked to vaginal mesh implants 

As more women report transvaginal mesh problems to their doctors, the number of products liability lawsuits involving mesh products continues to grow into the tens of thousands. It is estimated that many women experiencing vaginal mesh side effects may not report their injuries to their doctors because they are not aware that malfunctioning surgical mesh may be the cause.

Some of the serious complications associated with TVM include:

  • Mesh erosion
  • Infection
  • Irregular bleeding
  • Vaginal tightening
  • Vaginal shortening
  • Perforation of the bladder
  • Perforation of the bowels
  • Perforation of the blood vessels
  • Painful intercourse
  • Pain during urination

For the millions of women who have had these devices implanted, a vaginal mesh recall would come too late to prevent complications. Unfortunately, when problems do occur, repeated revision surgeries may be necessary to remove all of the mesh that has become entwined with the tissues of the body.  The cost of treatment could be high and the mesh could cause significant ongoing pain.

30,000 mesh lawsuits and counting

More than 30,000 women have filed lawsuits against TVM makers seeking damages for costs of treatment, the emotional and physical pain caused by their injuries, loss of wages, loss of quality of life, and loss of spousal consortium. Many of the cases have been consolidated into different multidistrict litigations (MDLs), which means cases from all over the country are brought before the same judge, who has the opportunity to rule broadly on legal questions that are common to all of the different claims.

A transvaginal mesh attorney can help victims to pursue claims and obtain compensation for their losses caused by TVM devices. While a surgical mesh recall could potentially help plaintiffs by providing more proof of a link between their health issues and the use of the surgical mesh, plaintiffs can recover compensation for injuries even though no recall has been implemented.

Some plaintiffs have already been compensated for injuries, and if you or a loved one was affected by TVM, it is a good idea to contact a surgical mesh lawyer today.

  1. FDA, Surgical Mesh, 
  2. FDA, Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence,
  3. Bloomberg, J&J Mesh Approved by FDA Based on Recalled Device,
  4. FDA Safety Communication, UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse,
  5. Obstetrics & Gynecology, Effectiveness of Mesh Compared With Nonmesh Sling Surgery in Medicare Beneficiaries,