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Vaginal mesh implants, sometimes called transvaginal mesh implants, are used to treat a variety of conditions. Typically, they are used to treat pelvic organ prolapse, urinary stress incontinence, and pelvic prolapse. Normally, such devices must undergo stringent testing before going to market to prove their usability and success in treatment. However, when a device is similar to other devices on the market, they can be placed on the market before testing is completed. A Johnson & Johnson subsidiary was successfully sued over such a device, as Medical Plastic News reports.
51-year-old Ella Ebaugh was awarded $57 million by a jury in a case involving a TVT-Secur device she had implanted in 2007 after suffering from incontinence.
Ethicon, a Johnson & Johnson subsidiary, manufactured the devices. In court documents, it was revealed that the product was developed to address issues in Ethicon’s previous mesh products. It was rushed to market without trial, using a 510(k) pre-market certification. This allowed the product to bypass clinical trial as it was similar to other devices already on the market.
A study conducted after the product going to market done on 40 patients revealed the device had only a 77% success rate. Ethicon’s previous device had a success rate of 85-90%.
In Ebaugh’s case, the device was unsuccessful and she had to have a secondary device implanted. She suffered from complications such as pelvic pain and urethral erosion. Ebaugh had to undergo three subsequent corrective surgeries.
The TVT-Secur device was later removed from the market in 2012.
An Ethicon spokesperson said that they plan on appealing the verdict.
Have you been injured due to the implantation of a transvaginal mesh device? Let the experienced attorneys at the law offices of John Foy & Associates fight to get you the compensation you deserve. Call us today.
