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FDA: Transvaginal Mesh to Repair POP Poses Risks

The FDA has issued an updated safety communication warning that surgical placement of transvaginal mesh to repair pelvic organ prolapse may expose patients to a greater risk of side effects than other treatment options.

Consumer Alert: The U.S. Food & Drug Administration (FDA) has issued an updated safety communication warning that surgical placement of transvaginal mesh to repair pelvic organ prolapse (POP) may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of life than other surgical methods. The administration is advising doctors and patients to weigh the risks vs. benefits of transvaginal mesh carefully prior to undergoing any operations.

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 Case Evaluation: If you or a loved one has been injured by transvaginal mesh, 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?

Pelvic Organ Prolapse (POP) is a serious medical condition that occurs when the internal structures that support the pelvic organs become so weak that one or more of the organs – the bladder, uterus or bowel – drop (prolapse) into the vagina. POP is a common condition, affecting roughly 30 percent of women age 45 or older. Signs and symptoms of pelvic organ prolapse may include:

  • abnormal bladder or rectal function
  • pelvic pressure or heaviness
  • bulging in the pelvic region
  • pain
  • bladder infections
  • vaginal discharge
  • discomfort or lack of sensation during sex

POP can be caused by a number of factors including smoking, menopause, obesity, family history, pelvic trauma, previous surgeries, multiple vaginal deliveries and certain medical conditions such as diabetes or connective tissue disorders. Surgical methods to repair POP can be performed through the abdomen or transvaginally by using stitches or with surgical mesh to reinforce the repair and correct the anatomy. Last year alone, there were at least 100,000 POP surgeries that used vaginal mesh, approximately three-quarters of which were transvaginal procedures.

“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”

Side Effects of Transvaginal Mesh

In 2008, the FDA published a press release warning the public about adverse events linked to transvaginal mesh. In the three years since the warning, the number of adverse event reports have risen exponentially. From 2008 to 2010, the FDA received at least 1503 adverse event reports associated with transvaginal mesh, five times more than were reported in the two previous years. The most frequently reported side effects of transvaginal mesh products include:

  • mesh becoming exposed / protruding out of the vaginal tissue (erosion)
  • pain
  • infection
  • bleeding
  • pain during sexual intercourse
  • organ perforation
  • urinary problems

Unfortunately, many of these side effects require hospitalization and additional surgeries to correct.

Additionally, the Food & Drug Administration has conducted a comprehensive review of scientific literature published over the last 15 years comparing POP mesh surgeries to procedures that did not use mesh. The FDA review concluded that patients who underwent transvaginal surgeries with mesh exposed themselves to a greater number of risks and side effects compared to patients who underwent POP surgery with stitches alone.

If You are Preparing for POP Surgery

If you are preparing to undergo an operation to correct pelvic organ prolapse, the FDA recommends that you consult your doctor about all POP treatment options (especially those that do not involve mesh), and continue with routine check-ups and follow-up care after surgery. Also, it is important that you notify your physician immediately if any of the complications listed above develop. If you have had POP surgery and are unsure as to whether or not transvaginal mesh was used, ask your doctor during your next scheduled visit.

On September 8th, 2011, an independent panel of experts are set to meet to discuss the safety and effectiveness of surgical mesh used to treat POP and stress urinary incontinence (SUI), a painful and embarrassing condition caused by pelvic surgery or childbirth that occurs when a woman can no longer control her bladder. Among other things, the panel will discuss the risks posed by transvaginal mesh, potential clinical studies that may be needed to assess these risks, as well as the administration’s interim recommendations for patients and healthcare professionals.

“Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for POP and SUI repair, including any changes that would improve our oversight,” Maisel said.

Why You Should Choose Schmidt & Clark, LLP

At Schmidt & Clark, LLP, we have extensive experience in the area of defective medical devices and mesh-related injuries. In addition to our national representation of consumers injured by defective medical devices, our attorneys are actively investigating cases involving the use of transvaginal mesh products. We are able to draw on the pool of experience gained in other mesh and product liability litigations to accurately investigate, evaluate and pursue potential transvaginal mesh injury claims.

Do I have a Transvaginal Mesh 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 transvaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new transvaginal mesh cases in all 50 states.

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