Transvaginal Mesh Recall

More than 108,000 lawsuits have been filed alleging that transvaginal mesh causes complications, including pain, bleeding, infection, and organ perforation.

Side Effects and Complications Associated with Transvaginal Mesh

A transvaginal mesh, also known as a pelvic mesh, is a mesh device that is surgically inserted transvaginally for the treatment of women’s gynecological and urogynecological issues, such as pelvic organ prolapse or stress urinary incontinence.

Some models of Transvaginal Mesh products involved in lawsuits or recalled implants include:

  • American Medical Systems (or AMS)
  • Boston Scientific (or BSC)
  • Coloplast
  • Covidien
  • Johnson & Johnson (or Ethicon)

Legal case summary

  • One of the largest transvaginal mesh settlements to date was $830 million for 20,000 cases.
  • In 2021, Boston Scientific paid $189 million to settle a multistate lawsuit over the marketing of its surgical mesh devices.
  • The US Food and Drug Administration (FDA) announced in August 2021 that patients who had received mesh repair faced an increased risk of tissue erosion.
  • In April 2019, the FDA ordered manufacturers to stop selling all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse.
  • Johnson & Johnson and its Ethicon business unit paid out $117 million in a multistate settlement in 2019.
  • As of November 2019, more than 2,263 lawsuits were pending.
  • While J & J agreed to settle 2,000 to 3,000 lawsuits for $120 million in 2016, the company has continued to defend itself in court.

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