Side Effects & Risks

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TRANSVAGINAL MESH COMPLICATIONS AND INCREASED RISKS

After researching the problems linked to mesh products, the FDA stated that the risks of these devices are greater than the benefits. Officials announced that patients using mesh implants are vulnerable to increased risks. Some of these include:

  • Abscesses
  • Bladder spasms
  • Decreased quality of life
  • Disfigurement of the vagina
  • Hematomas
  • Incontinence
  • Mesh migration and protrusion
  • Organ injury
  • Pelvic pain
  • Scarring

In some women, attempts to remove the vaginal mesh were not successful. Besides surgery, treatment of mesh complications may include IV therapy and blood transfusions.

Increased Risks Related to Mesh Devices

The FDA approved the first vaginal mesh device in 1996 for the treatment of POP and SUI. Under Class II guidelines and the FDA 510(k) program, manufacturers needed to prove that their device was similar to those that were already available. This minimal requirement made the process of introducing new mesh devices fairly simple, and 40 companies were selling nearly 100 products at one juncture.

Some of the leading mesh device manufacturers, making billions of dollars in annual revenue, included:

  • American Medical Systems
  • Bard Medical
  • Boston Scientific
  • Coloplast
  • Johnson & Johnson

  • Schedule a Free, Confidential Legal Consultation to File a Mesh Lawsuit

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