Johnson & Johnson (J & J) announced last month that it plans to stop selling certain surgical mesh products used in women to repair pelvic organ prolapse. As we have written in previous issues, these surgical mesh implants have caused serious injuries to women and resulted in hundreds of lawsuits being filed. The company sent a letter to judges in New Jersey and West Virginia, who are overseeing lawsuits filed against the company, letting them know it plans to stop marketing the Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M over the next four months. All four of these products are composed of polypropylene mesh.
Pelvic organ prolapse is extremely common, affecting at least half of all women who have given birth and many women who have never been pregnant. Prolapse affects women as young as in their 30s as well as in their 70s and 80s. Pelvic organ prolapse occurs when the muscles and ligaments supporting a woman’s pelvic organs weaken and a pelvic organ slips out of place or prolapses. Prolapse can involve the bladder, uterus, vagina, or rectum.
Traditionally, doctors repaired pelvic organ prolapse using sutures or stitches. In the late 1980s, doctors began using polypropylene mesh to lift the organs back into place. These procedures involved an abdominal incision. In the late 1990s, doctors began to place the polypropylene mesh through an incision in the vaginal wall. The transvaginal placement of mesh has led to numerous problems. Discovery has shown that mesh placed transvaginally often breaks down in the body and/or becomes deformed. This can lead to chronic infection, incontinence, pain, erosion of the mesh into the vaginal wall, painful intercourse, and autoimmune issues, among other things. Over 200,000 women had transvaginal procedures for the repair of pelvic organ prolapse in 2011 alone. Untold thousands of women over the past ten-12 years have had these procedures.
In spite of all of the evidence to the contrary, J&J still claims the mesh products are safe and says there will be no recall. In an interesting media statement, the company said its decision to discontinue these products was based on “their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”
Based on our involvement in this litigation, I can say without reservation that J & J made some very bad decisions concerning the use of the transvaginal mesh implants. The FDA said 10 percent of women experienced erosion or exposure of the mesh within 12 months of having the mesh implanted, though it is probable that the percentage is as high as 25 percent. More than half of these women required follow-up surgery to remove the mesh. In fact, Lana Keeton, a Florida woman, had 17 surgeries to remove the mesh that was implanted in 2001. She started a group, Truth in Medicine, to work on this issue. Ms. Keeton has been very active in this fight.
It is significant that the FDA saw no evidence that using mesh led to better outcomes than traditional surgery with stitches. Due to safety concerns with these products and others like them, the FDA’s Office of Surveillance and Biometrics previously ordered Johnson & Johnson and five other manufacturers to conduct safety testing of these products. J&J apparently hopes the FDA will waive that requirement since it’s taking the products off the market. Consumer safety advocates hailed the announcement by J&J as a victory for women. It clearly was.
Between 2008 and 2010, the FDA received more than 1700 reports of adverse events involving pelvic organ mesh repair kits made by J&J and other companies. As a result, a large number of product liability lawsuits have been filed to hold the manufacturers accountable. In its last quarterly filing with regulators, J&J said the “number of pending product liability lawsuits continues to increase,” and that the company has set aside money to pay for litigation costs associated with the mesh. Federal cases against J&J were consolidated in the Southern District of West Virginia. The state cases in New Jersey have been centralized in a state court in Atlantic County.
MDLs were created against American Medical Systems, Inc. (MDL No. 2325); Boston Scientific Corp. (MDL No. 2326); and Johnson & Johnson (MDL No. 2327). Since 2010, Judge Joseph B. Goodwin has also been overseeing a MDL against another Transvaginal mesh manufacturer, C.R. Bard, Inc. That case is in re: Avaulta Pelvic Support Systems Product Liability Litigation, MDL No. 2187.
These companies know they will never be able to prove safety and efficacy of these devices in the studies mandated by the FDA in January. Public Citizen and other groups, including Truth in Medicine, have lobbied the FDA on the risks of mesh in recent years. Mesh products initially were seen as a high-tech improvement over traditional surgery, which also can have complications. Since similar mesh was already used in other types of surgery, the products received fast-track approval from the FDA without the tests that the agency requires for first-of-a-kind devices. That means there was no safety testing and the results have caused great harm to many unsuspecting women. The companies failed to inform the medical community of the potential for harm.
Our firm is representing a large number of women who have suffered severe injury. Complications from the transvaginal placement of the mesh include erosion of the mesh into vaginal tissue, organ perforation, pain, infection, painful intercourse, and urinary and fecal incontinence. Leigh O’Dell, a lawyer in our Mass Torts Section, was appointed by Judge Goodwin in April as a member of the Plaintiffs’ Steering Committee for all four MDLs. If you have any questions about this litigation, you can contact Leigh at 800-898-2034 or by email at Leigh.Odell@beasleyallen.com.
Sources: Associated Press and Wall Street Journal
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