Transvaginal Mesh Overview
For the 3.3 million U.S. women suffering from pelvic organ prolapse (POP), transvaginal mesh products offer structural support, as well as freedom from intimacy problems and urinary incontinence. Once implanted, the hammock-type mesh is meant to keep pelvic tissues and organs held in place.
However, the promise of this medical device has ended in disappointment and suffering for thousands of women who have filed transvaginal mesh product liability lawsuits in state and federal courts. The Sanders Firm is currently evaluating the experiences of women who have had these mesh products implanted only to suffer greater complications than prior to surgery. If you have been hurt by a pelvic mesh product, you are encouraged to call our team of personal injury lawyers to discuss your experience and determine if filing a transvaginal mesh lawsuit is the best course of action.
What is transvaginal mesh?
Surgical mesh has been used in hernia repair operations since the 1950s. In the 1970s, surgeons started using mesh products to treat pelvic organ prolapse as well. The early years involved cutting the mesh to a desirable shape, making an incision and implanting the mesh in the proper location. Over time, manufacturers began creating ready-to-use mesh kits — that included pre-shaped mesh pieces, surgical instruments and specialized tools – which would feasibly make the surgery easier. By 2004, a number of highly trained urological surgeons and gynecologists had adopted mesh slings marketed by Johnson & Johnson, Boston Scientific and other manufacturers.
Why are so many women filing transvaginal mesh lawsuits?
The Huffington Post reports that 10 percent of mesh devices fail within one year of implantation.
Transvaginal mesh complications include:
- Mesh erosion
- Nerve damage
- Organ puncture
- Chronic pain
- Inability to pass urine
- Relapse of SUI and POP
- Problems with sexual intercourse
- Revision surgery
“I was in the most horrendous pain I’ve ever experienced,” Amy Gezon, a 43-year-old mother of three, told WBUR News. “I finally ended up in the ER after expressing a desire to end my life just to escape the pain.” She added that had she known one-tenth of what she knows about transvaginal mesh now, she would have never consented to the surgery in the first place.
Part of the problem may be the way in which these products came to market. In 1996, Boston Scientific received FDA clearance for ProteGen, the first vaginally implanted mesh, designed to treat urinary incontinence specifically.
Two years later, Johnson & Johnson was given clearance to market a similar device called Gynecare TVT – even though they hadn’t conducted human testing – because it was “substantially equivalent” to Boston Scientific’s device.
After 123 reports of transvaginal mesh complications like discomfort, vaginal mesh erosion and painful sex, Boston Scientific pulled 20,000 ProteGen products from the market. Even so, other manufacturers continued to come out with new products they could sneak past clinical trials through the flawed FDA’s 510(k) clearance process.
According to Bloomberg News, the 510(k) system was “designed to vet low-risk devices such as surgical drapes” to get them to market faster, but also “became a gateway for items like joint implants and vaginal mesh” to skip through the system without appropriate device testing.
Another problem is the very concept of transvaginal surgery using synthetic mesh, Bay Area pelvic surgeon Michael Thomas Margolis told the FDA advisory panel. By nature, the vagina is not a very sterile environment; rather, it is home to flora that includes Staph and E. coli, which “cannot be surgically cleansed from the operative field.” Mesh infections cause the material to breakdown and erode through the vagina. Trying to remove all the mesh safely given all the nearby organs is another challenge, he added.
Lastly, surgeons may not have been trained to vet patients properly. Marketed as an ideal solution for all women suffering from stress urinary incontinence and pelvic organ prolapse, surgeons were inserting the mesh indiscriminately. However, Dr. Cheryl B. Iglesia, director of reconstructive surgery at the Washington Hospital Center, said that mesh slings are not recommended for young women who are still having sex, are eligible for other types of surgery, and have not had previous surgery to correct the problem.
Defendants named in pelvic mesh lawsuits
There are seven federal multidistrict litigations that centralize personal injury lawsuits filed by transvaginal mesh lawyers:
- MDL 2004: Mentor Corp. (Johnson & Johnson) ObTape Transobturator Sling Products – 514 cases*
- MDL 2187: C.R. Bard Pelvic Repair System Products – 5,505 cases*
- MDL 2325: American Medical Systems (Endo Health) Pelvic Repair System Products – 11,390 cases*
- MDL 2326: Boston Scientific Corp. Pelvic Repair System Products – 7,310 cases*
- MDL 2327: Ethicon (Johnson & Johnson) Pelvic Repair System Products – 11,589 cases*
- MDL 2387: Coloplast Corp. Pelvic Support Systems Products – 1,099 cases*
- MDL 2440: Cook Medical Pelvic Repair System Products – 133 cases*
*Note: Case information is based upon data from the Judicial Panel for Multidistrict Litigation as of December 2013.
The lawsuits detail a wide range of complications – from serious bleeding, injury to other organs and scarring – to mesh erosion, infection and severe pain. Plaintiffs are demanding compensation for past and future medical expenses, loss of earnings, as well as pain and suffering. Many spouses are seeking additional damages for loss of consortium.
Plaintiffs see early victories
July 2012 saw the resolution of the first transvaginal mesh lawsuit. The Bakersfield, California jury ruled in favor of plaintiff Christine Scott, who walked away with a $5.5 million verdict to cover her medical expenses, pain and suffering after eight surgeries and nine medical procedures related to the implantation of two C.R. Bard mesh devices.
Similarly, a New Jersey jury ruled in favor of Linda Gross and ordered Johnson & Johnson – manufacturer of the Gynecare Prolift system — to pay $11.1 million in damages after the South Dakota nurse suffered mesh erosion, scar tissue, inflammation and other complications from her 18 mesh repair operations.
In September 2013, two plaintiffs settled with C.R. Bard out of court for undisclosed sums. Lawyers for Endo Health Solutions, Boston Scientific, Coloplast Corp, Cook Medical and C.R. Bard told Bloomberg News that they are contemplating settling more cases out of court.
Talk to a product liability lawyer
The Sanders Firm is standing by to help victims suffering transvaginal mesh complications recover compensation for their pain, suffering, medical bills, and other financial losses. With over 45 years of successful trial experience in the field of pharmaceutical litigation, The Sanders Firm is a seasoned team of attorneys, paralegals, medical consultants and a highly trained support staff – all firmly committed to the plight of victims of dangerous medical devices, drugs, and common products. Call 1.800.FAIR.PLAY (24 hours a day, 7 days a week) to discuss your case with a dedicated member of our team.
- Huffington Post - Pelvic Mesh Lawsuits: Thousands Of Women Sue Over Surgical Mesh Complications http://www.huffingtonpost.com/2013/02/08/pelvic-mesh-lawsuits-surgical_n_2647435.html
- WBUR’S Common Health – Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh http://commonhealth.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh
- Bloomberg – J&J Vaginal Mesh Approved By FDA Based On Older Recalled Device http://mobile.bloomberg.com/news/2011-10-20/j-j-vaginal-mesh-approved-by-fda-based-on-older-recalled-device?category=%2Fnews%2Fmostread%2F
- Judicial Panel for Multi-District Litigation –December 2013 Pending Dockets http://www.jpml.uscourts.gov/pending-mdls-0
- Bloomberg -- Bard, Vaginal-Mesh Makers, Said to Be in Settlement Talks http://www.bloomberg.com/news/2013-09-30/bard-vaginal-mesh-makers-said-to-be-in-settlement-talks.html
- Bloomberg -- Bard, Doctor Ordered to Pay $5.5 Million Over Implant http://www.bloomberg.com/news/2012-07-24/bard-must-pay-5-5-million-over-vaginal-mesh-implants.html
- FOX News – Jury Awards $3.35 Million In Vaginal Mesh Case Against J&J http://www.foxnews.com/health/2013/02/26/jury-awards-335-million-in-vaginal-mesh-case-against-johnson-johnson/