Transvaginal Mesh/Bladder Sling/Transvaginal Tape (TVT)
Transvaginal mesh, bladder slings and transvaginal tape (TVT) are made of polypropylene and are used to treat pelvic organ prolapse (POP), an often painful condition that affects thousands of women annually and stress urinary incontinence (SUI). POP occurs when the connective tissue and muscles that surround and support the pelvic organs – including the bladder, bowel and uterus – grow weak or stretch, often after childbirth, causing the organs to drop below their normal position and bulge into the vagina. SUI is the leakage of urine during routine physical activity such as coughing, sneezing, laughing, or exercise.
Traditional surgery to treat POP uses a woman’s own tissue to support the prolapsing organs. When synthetic mesh is used, it is often implanted transvaginally to reinforce tissues around the descended pelvic organ.
Transvaginal mesh, bladder slings and TVT are marketed by numerous device manufacturers, including Boston Scientific, Caldera, Covidien, C.R. Bard, Inc., Ethicon, Gynecare, Sofradim, Mentor, Johnson & Johnson and other companies.
Since 2005, the United States Food and Drug Administration (FDA) has received over 3,000 adverse event reports of transvaginal mesh complications, including seven cases of death, regarding complications with transvaginal mesh devices used to repair POP and SUI. As a result, the FDA has issued two safety alerts regarding transvaginal surgical mesh products.
On October 20, 2008, the FDA warned that from 2005 to 2007 more than 1,000 individuals had reported experiencing complications with transvaginal surgical mesh. The most common complications for transvaginal mesh devices include vaginal mesh erosion (when the tissue between the mesh and the lining of the vagina breaks down and the mesh becomes exposed on the surface of the vagina), vaginal scarring, contraction or shrinking of the mesh, infection, neuromuscular problems, dyspareunia (painful intercourse) and onset or resurgence of urinary problems such as incontinence. In many cases, the complications led to severe pelvic discomfort and pain and the need to undergo a revision surgeries to excise or release the eroded mesh.
Three years later on July 13, 2011, the FDA announced that it had received 2,874 new adverse event reports regarding complications associated with transvaginal mesh procedures from January 2008 to December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. The studies indicate that approximately 10% of women who have surgical mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh.
The FDA further announced that it had identified mesh contraction as a new complication associated with POP repair and that it was not clear that POP repair involving transvaginal surgical mesh was better than traditional non-mesh procedures and may actually expose patients to greater risk of complications.
On January 4, 2012, the FDA ordered Johnson & Johnson, C.R. Bard, Boston Scientific, and thirty other manufacturers of transvaginal surgical mesh products to conduct new safety and efficacy studies of their products when used to treat POP and SUI following a recommendation from an FDA Advisory Panel in September 2011 that mesh for POP be reclassified as a high-risk medical device. Rather than conduct the required safety studies, some manufacturers have decided to discontinue selling certain transvaginal mesh, bladder sling, and TVT devices.
Transvaginal Mesh Litigation Update
The transvaginal mesh litigation is currently the largest medical device mass tort in the United States. Already some 70,000 claims have been court filed against the manufacturers of transvaginal mesh, bladder sling, and TVT devices. The number of transvaginal mesh lawsuits is expected to rise over time as additional devices fail.
Many of these claims have been consolidated into one of seven multidistrict litigations (MDLs) in federal court in the United States District Court for the Southern District of West Virginia before the Honorable Joseph Goodwin. Consolidations have also been established in a number of state court systems around the country, including New Jersey.
Since the transvaginal mesh litigation commenced, there have been a number of bellwether trials that have taken place across the country. The majority of these cases have resulted in verdicts for plaintiffs, including:
- In July 2012, a California jury awarded a woman $5.5 million against C.R. Bard for damages caused by an Avaulta mesh device.
- In February 2013, a New Jersey jury awarded a woman $11.1 million against Ethicon for damages caused by a Gynecare Prolift mesh device.
- In August 2013, a federal jury in West Virginia awarded a woman $3.75 million against C.R. Bard for damages caused by an Avaulta mesh device. This was the first bellwether trial in the C.R. Bard MDL, where tens of thousands of TVM cases have been filed.
- In April 2014, a Texas jury awarded a woman $1.2 million against Ethicon for damages caused by a Gynecare TVT-O mesh device.
- In September 2014, a Texas jury awarded a woman $73 million, including punitive damages, against Boston Scientific for damages caused by an Obtryx mesh device. This award was reduced to $34 million due to a Texas law that places limits on punitive damages
- In September 2014, a federal jury in West Virginia awarded a woman $3.27 million against Ethicon for damages caused by a Gynecare TVT-O mesh device.
- In November 2014, a Florida jury awarded four plaintiffs $26.7 million against Boston Scientific for damages caused by Pinnacle mesh devices.
- In November 2014, a federal jury in West Virginia awarded four plaintiffs $18.5 million against Boston Scientific for damages caused by Obtryx mesh devices.
- In March 2015, a California jury awarded a woman $5.7 million against Ethicon for damages caused by a Gynecare Abbrevo device.
- In May 2015, a jury in Delaware returned a $100 million in favor of Deborah Barba who was seriously injured by a transvaginal mesh device manufactured by Boston Scientific.
In February 2015, Judge Goodwin urged transvaginal mesh manufacturers to work hard to resolve the tens of thousands of lawsuits that have been filed against them rather than continue on with costly litigation. While some transvaginal mesh manufacturers have begun to settle claims, Boston Scientific, C.R. Bard, and Ethicon, who have the largest number of lawsuits filed against them and who have each been hit with one or more multi-million dollar verdicts, continue to state publicly that they intend to defend their products and try additional cases.
If you or a loved one has suffered complications from a transvaginal mesh, bladder sling or TVT tape device, you may be entitled to pursue a claim against the manufacturer for damages. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.