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2 years ago
Transvaginal Mesh Lawsuit Update: Ethicon Agrees to $120M Vaginal Mesh Settlement In January 2016, Johnson & Johnson agreed to pay over $120 million to settle 2,000 to 3,000 transvaginal mesh lawsuits alleging the pelvic mesh devices caused pain, organ damage and other injuries. A regulatory filing showed the company still faces another 42,000 pelvic mesh […]
Transvaginal Mesh Lawsuit Update
In January 2016, Johnson & Johnson agreed to pay over $120 million to settle 2,000 to 3,000 transvaginal mesh lawsuits alleging the pelvic mesh devices caused pain, organ damage and other injuries. A regulatory filing showed the company still faces another 42,000 pelvic mesh lawsuits. The vaginal mesh settlement is the first time J&J has agreed to resolve a large number of transvaginal mesh lawsuits.
Many device makers are being sued over vaginal mesh inserts, which are approved to treat stress urinary incontinence and pelvic organ prolapse. The largest number of lawsuits, however, have been filed against J&J’s Ethicon unit. Vaginal mesh lawsuits began in 2011; now, at least 100,000 lawsuits have been filed against manufacturers such as J&J, C.R. Bard and Boston Scientific.
Plaintiffs in the transvaginal mesh lawsuits have similar claims, alleging that the mesh is defective and led to injuries such as mesh erosion, where the mesh became embedded in the tissues of the body, causing severe pain and organ damage. Many plaintiffs allege undergoing multiple surgeries to remove the mesh, often successfully.
Transvaginal mesh lawsuits allege that device makers such as Ethicon failed to properly test their products before they were sold and implanted in thousands of women. This is because the devices were approved through 510(k), which allows devices onto the market without clinical testing. Manufacturers gaining approval through this route need only show that it is “substantially equivalent” to a previously approved device. This fast-track route is not intended for high-risk devices.
Pelvic mesh litigation and safety concerns have increased scrutiny over 510(k) and the devices that obtain approval through this route. Critics, patient advocates and experts have argued that transvaginal mesh should not have been approved through 510(k). In response, the FDA has since reclassified pelvic mesh as “high-risk”, meaning now they can only be approved with clinical testing for safety and efficacy.
In 2011, the FDA released a safety alert warning the public that complications associated with transvaginal mesh implants were “not rare”. This is contrary to what the agency communicated in 2008. The updated notification further states that transvaginal mesh inserts do not have clear benefits for patients with pelvic organ prolapse compared to non-mesh methods, and may pose more risks. In 2008, the FDA said the most common complications with transvaginal mesh were:
Women also reported that the mesh perforated their bowels, bladder and blood vessels when the device was inserted.
If you or someone you know suffered injuries related to the use of transvaginal mesh implants, you may have valuable legal rights. Parker Waichman’s transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOUR-LAWYER (1-800-968-7529).