Vaginal mesh is a surgical mesh vaginally implanted to treat women with Pelvic Organ Prolapse and Stress Urinary Incontinence. It has also lead thousands of women to suffer from serious vaginal mesh complications, including discomfort, painful sex, mesh erosion, and recurrence of the very conditions the vaginal mesh was meant to cure. Here’s a timeline of the events that ultimately led to thousands of vaginal mesh lawsuits filed by women who suffered from serious injuries:
What Went Wrong? Vaginal Mesh Lawsuits Timeline
- 1996 – 2008: numerous transvaginal mesh manufacturers received FDA approval to market vaginal mesh products for POP, SUI and other surgical procedures. The devices were approved through the FDA’s 510(k) process, which allowed them to go to market without clinical testing because it was based on a similar previously approved market. However, vaginal mesh’s approval was based on mesh used in other parts of the body (for example, for hernia repair), and was never tested for safety risks in transvaginal procedures.
- 1999: Boston Scientific issues a transvaginal mesh recall of about 20,000 ProtoGen vaginal mesh units after receiving reports of adverse effects, including pain during intercourse and erosion of vaginal tissue. Despite the recall, the FDA continued to approve similar vaginal mesh products for use.
- 2005 – 2008: The FDA receives over 1,000 reports of transvaginal mesh injuries from nine vaginal mesh manufacturers.
- 2008: FDA issues its first vaginal mesh safety alert, advising doctors of the reports of complications associated with the implants, though the agency states that complications are “rare.”
- 2008 – 2010: The FDA receives over 2,800 adverse event reports of vaginal mesh injuries.
- August 2010: A study published in The Journal of the American College of Obstetricians and Gynecologists concludes that the Ethicon Prolift, manufactured by J&J, is associated with high vaginal mesh erosion rates.
- July 2011: FDA issues warning about high rates of transvaginal mesh complications in treating POP. The agency reports a fivefold increase in vaginal mesh injuries from various models of the devices.
- September 2011: The Obstetrics and Gynecology Devices advisory panel to the FDA recommends that transvaginal mesh be reclassified to a high risk device. Manufacturers will have to undergo rigorous testing to receive FDA approval. The panel supports the FDA’s plans to require more pre-market approval studies for new transvaginal mesh devices.
- January 2012: the FDA orders 35 vaginal mesh manufacturers to conduct safety studies on transvaginal mesh implants and provide data on the safety and effectiveness of the products.
- June 2012: J&J issues an Ethicon transvaginal mesh recall of its Gynecare line of vaginal mesh products, though the company maintains that the recall is not safety related.
- December 2012: 8,000 vaginal mesh lawsuits have been filed in federal court and state courts. Women who suffered transvaginal mesh injuries continue to file lawsuits against various mesh manufacturers, including American Medical Systems, Boston Scientific, C.R. Bard and Johnson & Johnson.
Filing a Vaginal Mesh Lawsuit
If you received a transvaginal mesh implant and suffered from complications, speak to a lawyer today to learn more about how you may be entitled to compensation for your medical expenses and injuries. The vaginal mesh lawyers at Bernstein Liebhard LLP have spoken to hundreds of women and understand sensitive nature of your injuries. We will help you understand your legal rights and are fierce advocates for your claims. To learn more, call 1-888-217-3033 or submit the free case evaluation form on this page.