Transvaginal Mesh Lawsuit
Motley Rice is litigating cases in which recipients of transvaginal mesh/ sling products (also called pelvic mesh) have suffered from serious complications. From 2005 to 2010, there have been nearly 4,000 injuries reported to the Food and Drug Administration (FDA) following the placement of a transvaginal mesh (TVM) device.
Motley Rice lawyers hold leadership roles in pelvic mesh cases filed in state and federal courts, representing hundreds of clients in transvaginal mesh lawsuits. Reported complications involve pelvic mesh made by numerous manufacturers, including Boston Scientific, American Medical Systems, Inc. (AMS), C.R. Bard, Inc., and Johnson & Johnson.
Contact a Transvaginal Mesh Lawyer
If you or someone you know has experienced adverse transvaginal mesh side effects, contact lawyers Fidelma Fitzpatrick or Jonathan Orent by email or call 1.800.768.4026.
Transvaginal Mesh Lawsuits
On April 30, 2014, Motley Rice co-founding member Joe Rice announced that an Agreement in Principle has been reached with TVM manufacturer American Medical Systems, Inc. (AMS) and parent company Endo International plc on behalf of thousands of eligible TVM clients in the multidistrict litigation In re American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2325). This settlement will be available to approximately 6,000 women who used AMS’s transvaginal mesh device and will be implemented over the next 12 months. The Settlement Agreement does not impact all TVM cases or litigation involving other TVM manufacturers, including Boston Scientific, C.R. Bard, Inc., and Johnson & Johnson.
On June 4, 2012, Chief Judge Joseph Goodwin and Magistrate Judge Mary Stanley of the U.S. District Court for the Southern District of West Virginia were notified in a letter of developments regarding Ethicon MDL 2327, In re Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation. The letter informed the court that Ethicon is voluntarily recalling four Pelvic Floor Repair Systems in the United States, discontinuing or changing its marketing materials and revising product labeling to limit the use of certain products to abdominal procedures. Ethicon also asked the FDA to allow it 120 days to stop commercialization, notify customers and let hospitals and physicians choose alternative patient treatments. Motley Rice represents clients in more than 100 filed cases naming Ethicon as a defendant. Read the full notification letter.
On April 13, 2012, The Honorable Judge Joseph Goodwin appointed Motley Rice member Fred Thompson as co-lead coordinating counsel, along with Bryan Aylstock (Aylstock, Witkin, Kreis, and Overholtz) and Henry Garrard (Blasingame, Burch, Garrard, Ashley), for the pelvic mesh lawsuits consolidated in the U.S. District Court for the Southern District of West Virginia. Member Fidelma Fitzpatrick was also appointed co-lead counsel of MDL 2325. The MDLS are:
- In re C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2187)
- In re American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2325)
- In re Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation (MDL 2326)
- In re Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2327)
On Oct. 12, 2010, the Honorable Carol E. Higbee of the Superior Court of New Jersey Law Division, Atlantic County, ruled in favor of centralized management without mass tort designation for all filed complaints and all future complaints in the transvaginal mesh cases In re J & J Litigation and In re Bard Litigation. The cases are separate but coordinated.
Motley Rice attorneys Fidelma Fitzpatrick and Jonathan Orent serve as co-liaison counsel in the In re Bard Litigation in New Jersey state court, as well as state court liaison counsel in Massachusetts. Fitzpatrick also serves as state court liaison counsel in Delaware. Fred Thompson serves as the liaison between this litigation and the Bard Avaulta multidistrict litigation in West Virginia federal court.
Transvaginal Mesh Side Effects
The following injuries or side effects have been associated with the implantation of pelvic mesh products:
- Chronic vaginal drainage
- Erosion of the vaginal tissue
- Feeling as though something is protruding from the vagina
- Lower back pain
- Pain during intercourse
- Perforations of the bowel, bladder or blood vessels
- Pressure or feeling of "fullness" in the lower abdomen
- Reoccurrence of pelvic organ prolapse (POP) or stress urinary incontinence (SUI)
- Urinary problems
- Vaginal bleeding
- Vaginal infections
- Vaginal pain not related to intercourse
- Vaginal scarring
Transvaginal Mesh History
Pelvic mesh devices are implanted through surgery. According to the FDA, contributing factors to complications may include the patient's health, mesh material, the size and shape of the mesh, surgical procedures and estrogen levels.
In September 2011, the FDA issued a recall of transvaginal mesh devices. Boston Scientific Corporation's Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE were recalled because they may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement. An FDA advisory panel also met to discuss the safety of medical drugs and devices, including transvaginal mesh, and recommended tougher premarket testing of vaginal mesh products and the reclassification of the devices to a Class III—the highest-risk category for medical devices—without recalling existing products.
A 2011 study released by the Journal of Obstetrics and Gynecology Canada (JOGC) on pelvic mesh procedures stated, "Until adequate effectiveness and safety evidence is available, the use of new TVM devices for prolapse repair should be considered experimental and restricted to use in investigative trials." Read the full JOGC report.
The FDA warned patients and healthcare providers in July 2011 of the risks associated with the use of transvaginal mesh and recommended they consider alternatives to for treating POP and SUI, conditions that may occur after childbirth and pregnancy. According to the FDA, nearly 40 percent of women between the ages of 35 and 54 suffer from SUI. In 2010, more than 10,000 women underwent vaginal mesh surgery to repair POP alone.
In an article published in an August 2010 issue of the Obstetrics & Gynecology, researchers reported that scientists had to stop a transvaginal mesh clinical trial early because women implanted with the mesh experienced too many complications. In the trial, which began in 2007, 65 women with POP underwent either surgery using the pelvic mesh or a procedure known as colpopexy that uses ligaments to help support the muscles. The trial was cut short in 2009 after researchers found that more than 15 percent of the women implanted with the mesh suffered within a period of only three months from vaginal mesh erosion, a potentially serious complication involving the protrusion of the mesh when the skin splits.
In October 2008, the FDA issued a public health notification alerting healthcare providers and the public about the increasing number of serious health issues associated with the transvaginal mesh. Reported complications include mesh from nine different manufacturers.
Contact pelvic mesh lawyers Fidelma Fitzpatrick or Jonathan Orent by email or call 1.800.768.4026 if you or someone you know has experienced complications that may be due to a transvaginal mesh device.