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Public Citizen: Vaginal Mesh Products Should be Recalled

The watchdog group Public Citizen is calling on the U.S. Food & Drug Administration (FDA) to recall a number of surgical mesh products because of painful and debilitating side effects.

The watchdog group Public Citizen is calling on the U.S. Food & Drug Administration (FDA) to recall a number of surgical mesh products because of painful and debilitating side effects. A high number of reports have linked the controversial devices to erosion, pain, bleeding and urinary incontinence. The product liability lawyers at Schmidt & Clark, LLP are currently investigating lawsuits nationwide on behalf of those injured by surgical mesh side effects.

Transvaginal Mesh Lawsuit Update 8/1/12: According to a plaintiff’s attorney in what appears to be the latest in a string of transvaginal mesh (TVM) lawsuits filed around the country over the past several months, Boston Scientific Corporation knew – or should have known – about the health risks associated with its products. The plaintiff, from Tennessee, was reportedly implanted with a Boston Scientific Obtryx Tansobturator Mid-Urethral Sling System, and subsequently suffered debilitating personal injuries. Click here to learn more.

Vaginal Mesh Lawsuit Update 7/26/12: Last Friday, a jury ruled that medical technology giant C.R. Bard and a doctor must pay a total of $5.5 million in damages over a vaginal mesh implant that left a woman with persistent pain and potentially irreversible injuries.The landmark case is the first to go to trial among hundreds of lawsuits alleging that vaginal mesh implants made by Bard, Johnson & Johnson, and Boston Scientific caused severe organ damage and other serious injuries. Click here to learn more.

Transvaginal Mesh Update 6/26/12: Healthcare behemoth Johnson & Johnson (J&J) continued to sell its controversial Gynecare Prolift transvaginal mesh patch for nine months after the FDA ordered it to stop, according to court records. In a letter sent Aug. 24, 2007, the administration asked the company to halt sales of the Prolift until it could determine whether the device was ‘substantially equivalent’ to other products on the market. Click here to learn more.

Transvaginal Mesh Lawsuit Update 6/21/12: A judge has lifted the discovery stay in the federal transvaginal mesh (TVM) litigation, as scores of new cases continue to be filed on behalf of women in courthouses around the country. All discovery was stayed earlier this year in federal lawsuits involving transvaginal mesh products used for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Click here to learn more.

Free Transvaginal Mesh Side Effects Lawsuit Case Evaluation: If you or a loved one has been injured by a defective transvaginal mesh product, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

August 25, 2011 – According to a statement released today by Public Citizen, vaginal mesh products made by Johnson & Johnson and Boston Scientific Corp. should be recalled immediately because their synthetic material has been found to erode and cause of number of painful side effects.

Transvaginal mesh products are designed to correct failing organs, and are implanted through incisions made in the wall of the vagina to reinforce the tissues around the pelvic organs. It has been estimated that nearly 70,000 women had transvaginal mesh products implanted in 2010 alone. Between January 2008 and December 2010, the FDA received more than 1,500 reports of serious complications associated with the products when used to repair pelvic organ prolapse (POP).

“Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately,” Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a statement.

The FDA has stated that it is uncertain as to whether vaginal mesh products are any more effective than traditional surgical procedures. Public Citizen is urging the administration to require manufacturers to recall vaginal mesh devices currently on the market, and to subject future versions to more stringent approval requirements.

Vaginal Mesh Side Effects

The FDA has stated that the most frequently reported complications involving transvaginal mesh have included the following:

  • erosion through vaginal epithelium
  • infection
  • pain
  • urinary problems
  • recurrence of prolapse and/or incontinence
  • bowel, bladder, and blood vessel perforation during insertion
  • vaginal scarring
  • mesh erosion

Why was surgical mesh approved by the FDA?

With all the controversy surrounding vaginal mesh, one has to wonder how such a potentially dangerous product made it to the market in the first place. Unlike the approval process for new drugs, many medical devices are cleared by the FDA without clinical trial data requirements. Companies who demonstrate that their products are ‘substantially similar’ to other previously-approved devices can get clearance to market. Under this system, surgical mesh was cleared for use in treating incontinence in 1996, and for POP in 2002.

In 2009, the Government Accountability Office criticized the Food & Drug Administration for its approval process, saying the agency’s reckless clearance of medical devices was compromising patient safety. However, even if transvaginal mesh products are required to submit formal approval applications, the FDA is likely to keep the devices on the market for the foreseeable future.

“We don’t think it would be appropriate to remove the products from the market right now,” said Dr. William Maisel, a chief scientist for the FDA’s medical devices division. “However, we do think it’s important that patients and health care providers have the information we have about the adverse events and the lack of evidence for clinical effectiveness so that they’ll be judicious in the use of this product.”

If you have experienced any side effects caused by a defective transvaginal mesh sling, the product liability lawyers at Schmidt & Clark, LLP may be able to help you pursue compensation for your injuries. Fore more information, fill out the Free Case Evaluation form below, or call us at (866) 588-0600.

Do You Have a Vaginal Mesh Side Effects Lawsuit?

The Product Liability and Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in vaginal mesh side effects lawsuits. We are handling individual litigation nationwide and currently accepting new vaginal mesh side effects injury cases in all 50 states.

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