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Transvaginal Mesh

Pelvic Organ Prolapse (“POP”) affects almost one-third of all women, and it occurs as women age or after childbirth. POP may cause some women’s social, working, and sexual lives to suffer, and it can be isolating and embarrassing. Pelvic Organ Prolapse occurs when the pelvic floor tissues and muscles no longer support the pelvic organs. This results in the pelvic organs dropping from their normal position. Pelvic organs include the bladder, vagina, rectum, urethra, and cervix.[1] Many women have undergone transvaginal mesh surgery to fix their POP. However, when complications arise from transvaginal mesh, they are often more severe and life-threatening than the condition it treats. More than 100,000 lawsuits have been filed against transvaginal mesh manufacturers, and most of the lawsuits have been settled.

If you or a loved one have suffered due to transvaginal mesh complications, contact Counsel Hound today for a no-cost consultation and case evaluation.

United States Best Hernia Mesh Lawyers

Transvaginal Mesh Side Effects

The FDA lists the following as side effects of transvaginal mesh malfunctions:[2]
  • Surgery site infection, pain, discomfort, irritation, or allergic reaction,
  • Difficulty urinating, incontinence, and involuntary urination,
  • Pain during activities, including urination and sexual intercourse,
  • Organ perforation or mesh erosion into nearby organs and tissue,
  • Recurrent pelvic organ prolapse.

Transvaginal Mesh Manufacturers

Common transvaginal mesh manufacturers include:
  • American Medical Systems
  • Boston Scientific
  • Coloplast Corp.
  • C.R. Bard, Inc.
  • Ethicon, Inc.

FDA Recall

In 2016, transvaginal mesh was reclassified as Class III, the FDA’s most stringent review process. It requires submission of premarket approval. In April of 2019, the FDA ordered all manufacturers of transvaginal mesh products to stop selling and distributing their products immediately. The FDA determined Boston Scientific and Coloplast did not demonstrate “reasonable assurance of safety and effectiveness” for their devices. The manufacturers were given ten days to submit their withdrawal plans to the FDA. Women who received transvaginal mesh were encouraged to continue attending their annual and other routine checkups. Still, the FDA announced no need to take additional action if you are not experiencing any complications.[3]

FDA Actions Timeline

2011: The FDA issued a safety communication and recommendations regarding transvaginal mesh products. The FDA also convened a panel meeting to discuss the benefits and risks of transvaginal mesh.

2016: Transvaginal mesh is reclassified as Class III and requires premarket approval applications to stay on the market.

2018: Manufacturers that did not file premarket approval applications by the July 2018 deadline were required to remove their products from the market.

2019: The FDA convened an advisory committee meeting to discuss the risks and effectiveness of transvaginal mesh. All manufacturers of transvaginal mesh were required to stop selling and distributing their products immediately.

Compensation

Transvaginal mesh complications can leave you with physical, emotional, and financial hardships. Our Counsel Hound lawyers will work to maximize your settlement or award. Types of compensation you may be eligible for include economic and non-economic damages.
Economic Damages:
  • If you incurred medical expenses related to the diagnosis and treatment of your condition, we would work to reimburse you.
  • If the condition forced you to miss work or suffer a wage decrease at a new position, we would prove your losses with timesheets.
  • If you lost a loved one due to transvaginal mesh complications, you might be eligible to file a wrongful death suit.
Non-Economic Damages:
Some damages cannot be proven with lost wages, property damages, etc., and you and your loved ones may face emotional suffering because of the condition. Our lawyers will work to include all available compensation in your case.

FAQs

Counsel Hound offers no-cost consultation and case evaluations. Many lawyers work on a contingency fee meaning the attorney fees come from your settlement award once you win. If there is no recovery, you will not have to pay anything.

REFERENCES

  1. https://www.fda.gov/ medical -devices/urogynecologic- surgical-mesh-implants/pelvic -organ-prolapse-pop
  2. https://www.fda.gov / media/81123/ download
  3. https://www.fda.gov/ news-events/ press- announcements/ fda-takes-action- protect -womens-health-orders-manufa cturers-surgical-mesh-intended -transvaginal

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Law is complicate matter. It can cause you a big problem if you ignore it. Let us help you!