In 2010 alone, 208,000 women received mesh sling implants to correct incontinence. An additional 75,000 women received mesh implants to treat prolapsing organs. More recently, however, the FDA warned mesh procedures offered no benefit over more traditional non-mesh procedures and may even place patients at a greater risk of developing complications such as erosion, infection and pain.
Free Mesh Removal Lawsuit Evaluation: If you or a loved one has been injured or suspect that you may have complications directly linked to a mesh implant, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
FDA Warnings on Mesh
Surgical mesh implants have been used in surgeries since they were first introduced in hernia repairs in the 1950s. Proven effective, surgeons began experimenting in the 1990s with vaginally-placed mesh products to treat pelvic organ prolapse and incontinence.
As the vaginal mesh products resembled previously-approved mesh products already on the market, the FDA approved mesh in incontinence procedures in 1996 and in pelvic organ prolapse repairs in 2002.
Pelvic organ prolapse, or POP, occurs when the tissue and muscles surround the pelvic organs weaken or stretch, causing the organs to sag or bulge into the vaginal wall. Incontinence occurs during moments of activity and is characterized by leakages of urine following sneezing, coughing, laughing or exercise.
Unfortunately, the FDA has received at least 3,874 reports of injury, death and malfunction associated with mesh products. In 2008, the agency warned that mesh products have been linked to higher risks of post-operative complication, after receiving over 1,000 reports of complication including erosion. The FDA warned the complications could decrease a patient’s quality of life and lead to pain during sexual intercourse.
In July 2011, the FDA further warned complications were not rare, as previously believed. Additionally, evidence suggested mesh procedures actually offered no additional benefit over traditional non-benefit procedures and may even place patients at higher risk. The FDA advised it had received an additional 2,874 reports of injury, death and malfunction.
The most commonly reported complication associated with failing mesh implants was erosion. Erosion occurs when the mesh fails to properly bind to the abdominal tissues, causing the mesh to shrink and protrude through the vaginal tissue and into the vaginal wall.
Erosion may lead to other side effects like infection, bleeding, vaginal discharge, organ perforation, pelvic pain, vaginal pain, vaginal scarring or shrinkage, neuromuscular problems, dyspareunia (pain during sexual intercourse), inability to engage in sexual intercourse, new onset of urinary incontinence, vaginal scarring or shortening, mesh contraction, and decreased quality of life.
Vaginal Mesh Lawsuits
Across the country, lawyers are currently taking cases on behalf of women injured by vaginal mesh.
In July 2012, C.R. Bard was found liable for $3.6 million in damages after a vaginal-mesh implant injured a woman. Jurors in California state court concluded that Bard was negligent in its handling of the Avualta Plus implant and did not appropriately testing it before releasing it onto the market. The woman required as many as nine follow-up surgeries to deal with complications caused by the mesh.
The state court victory was viewed as a promising outcome underscoring the compelling case against other mesh makers.
Thousands of cases have been compiled into several multidistrict litigations, or MDLs, to be heard by U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia. MDLs take similar cases and group them together under one judge to speed up the legal process. MDLs are similar to class action suits, but allow each case to maintain their individuality, allowing for more adequate individual compensation.
In February 2013, Judge Goodwin was scheduled to hear opening statements in the MDL against C.R. Bard. The case will be the first at the federal level to contend C.R. Bard’s Avaulta device caused organ damage or erosion. Other MDLs are scheduled against Johnson & Johnson, American Medical Systems, Inc., Boston Scientific Corp., and other manufacturers.
Do I have a Mesh Removal Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in mesh lawsuits. We are handling individual litigation nationwide and currently accepting new vaginal mesh lawsuits in all 50 states.
Free Transvaginal Mesh Lawsuit Evaluation: Again, if you or a loved one has received a transvaginal mesh implant as part of a POP or SUI repair, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.