Litigation over pelvic mesh devices continues to move forward, with women alleging that transvaginal mesh implants caused serious and often permanent injuries. The largest verdict in the litigation thus far was recently issued against Boston Scientific, who was ordered to pay $100 million to a woman implanted with the company’s Pinnacle and Advantage Fit mesh inserts. The jury found that Boston Scientific failed to warn patients and doctors about the risks of mesh devices and that they were negligent in designing them. The woman was awarded $25 million in compensatory damages and $75 million in punitive damages.
Pelvic mesh is approved to treat pelvic organ prolapse and stress urinary incontinence. The device is meant to reinforce the strength of the pelvic walls and counteract sagging organs. In recent years, however, injury reports have fueled safety concerns and thousands of lawsuits.
The plaintiff in the most recent case was implanted with the mesh inserts in 2009. In 2011, she filed a lawsuit alleging that the mesh caused serious injuries. She underwent two surgeries to correct the issues to no avail, her suit alleged. The jury’s verdict is the sixth issued against Boston Scientific, and the largest handed down to any manufacturer over transvaginal mesh. In one case, a woman from Texas was awarded $73.4 million. This amount was later reduced to $34 million. In April, the company announced that it would pay $119 million to settle 2,970 pelvic mesh cases.
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Parker Waichman LLP represents numerous individuals in the transvaginal mesh litigation. If you or someone you know suffered complications related to pelvic mesh inserts, contact our firm today for more information about your legal rights.
Seven manufacturers, including Johnson & Johnson’s Ethicon unit and C.R. Bard, are facing 100,000 lawsuits in state and federal courts pertaining to pelvic mesh devices, Reuters reports. Many lawsuits are consolidated in a multidistrict litigation (MDL) centralized in the U.S. District Court for the Southern District of West Virginia before U.S. District Judge Joseph Goodwin. Ethicon was ordered to pay $3.27 million after losing the first trial last September.
Other large verdicts have been issued against the device makers. In September, a jury ordered Ethicon to pay $3.3 million to a woman implanted with its TVT-O transvaginal sling. Ethicon was found to be responsible on all counts, including strict liability, design defect, failure to warn and negligence. In January, a judge refused to overturn a $2 million verdict against C.R. Bard, who argued that there was not enough evidence to support the verdict. In March, a California jury ordered Ethicon to pay a $5.7 million verdict over another mesh device; the jury awarded $700,000 in compensatory damages and $5 million punitive damages.
In June 2012, J&J announced it would stop selling four types of transvaginal mesh, including the Gynecare Prolift Pelvic Floor Repair System, Gynecare Prolift+M, Gynecare TVT Secur System and Gynecare Prosima.
A number of lawsuits point out that transvaginal mesh implants were not clinically tested for safety or efficacy before they were sold and implanted in thousands of women. This is because the devices were approved through 510(k), which allows manufacturers to forego the need for such testing if they can prove that the new device is “substantially equivalent” to an older product. Women allege that the mesh caused injuries such as mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems.
While the FDA has decided to reject a total ban on the devices, the agency is considering reclassifying the devices to Class III, which is the highest risk category. Reclassification of pelvic mesh into this category would require manufacturers to conduct clinical testing for safety and efficacy.
In 2008, FDA said that the most common complications associated with mesh implants are erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. In 2011, the agency updated this information to warn that these adverse effects are “not rare”, stating that these devices may put patients at greater risk compared to traditional non-mesh procedures for POP.
Transvaginal mesh implants have become controversial in light of numerous injury reports and mounting litigation. If you or someone you know has any questions about filing a lawsuit over transvaginal mesh, contact Parker Waichman LLP today.