A Colorado woman is the latest to be represented by the national law firm of Parker Waichman LLP in a fight over the defective transvaginal mesh surgical devices manufactured and marketed by Johnson & Johnson and Ethicon Inc.
According to an announcent from the firm last week, the Plaintiff in Parker Waichman’s latest filing to be added to the In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327), a woman from Colorado was implanted with the TVT transvaginal mesh device during a November 2010 procedure to treat developing conditions stress urinary incontinence and pelvic organ prolapse.
The Food and Drug Administration recently approved the use of transvaginal mesh devices in the treatment of these two painful conditions affecting millions of women annually. The agency did so through its maligned 510(k) “fast-track” approval system that grants access to the market based on a new medical device’s similarities to previously-approved devices.
Based on the number of adverse events linked to transvaginal mesh devices, especially in the last year, that decision may have been unwise by the FDA. Thousands of women across the country have been affected by defective transvaginal mesh devices like Johnson & Johnson and Ethicon’s TVT device.
Transvaginal mesh devices have been linked to a wide array of complications, many of which are painful and frustrating, especially as surgical attempts to correct these problems often fail and only lead to more complications. Among the side effects of transvaginal mesh devices are erosion through the vagina, pain, infection, bleeding, pain during intercourse, organ perforation, and other urinary problems.
The Plaintiff in the latest Parker Waichman lawsuit believes complications arose with the TVT device soon after it was implanted.
Many women who’ve been implanted with this or other devices have found life to be more difficult once complications arise. Some women even have reported that they’ve been unable to sit, stand, or sleep in one position too long due to the pain the compromised mesh devices posed.
Realizing that it may have erred, the FDA in July 2011 ordered makers of transvaginal mesh devices to begin conducting post-market safety tests to determine their efficacy in treating these conditions. Since that announcement, some companies have ordered a recall on some models of mesh devices. Johnson & Johnson announced that it would stop selling several models of transvaginal mesh devices, including Prolift, Prolift + M, TVT Secur, and Prosima.