On January 15 of this year, the trial of Gross vs. Johnson & Johnson’s Ethicon division began. As of February 1, 2013, six federal litigation actions remain pending in the courts of New Jersey and West Virginia against the manufacturers of transvaginal mesh. Over 6,000 victims hope the federal courts award them financial compensation for injuries endured secondary to mesh implants. Hundreds more await hearings in state courts. Manufacturers in the midst of the litigations include American Medical Systems, Boston Scientific Corp. and Coloplast along with C.R. Bard, Johnson & Johnson and Mentor.
In the case involving Ethicon, attorneys remain in the process of determining the manufacturer’s liability while establishing if the company had knowledge concerning the safety and possible hazards related to the mesh. A recipient of Ethicon’s Gynencare Prolife System, Linda Gross endured 18 corrective surgeries for tissue repairs secondary to the mesh implant. She continues experiencing pain despite medical intervention. The trial may serve as a precedent for the 1,900 additional cases filed in Atlantic City.
Transvaginal Mesh Compensation Awarded
Recently, a Bakersfield, California court jury awarded a couple $5.5 million as compensation for damages incurred from a transvaginal mesh manufactured by C.R. Bard. The award may prove the standard for all mesh lawsuits regardless whether implanted for repair of a pelvic organ prolapse or as correction for stress urinary incontinence. Reports indicate that surgeons inserted approximately 300,000 mesh devices by 2010. Many wonder how many of these patients eventually become entangled in lawsuits.
Boston Scientific Corp. reported a fourth quarter decline of seven percent in Women’s Health sales. Undoubtedly, many vaginal mesh companies undergo financial repercussion since the FDA reported accumulating complaints in 2011. With more physicians aware of the problem, mesh sales undoubtedly declined. With untold amounts of monetary compensation forthcoming, companies face further financial straits.
Transvaginal Mesh Complications
Mesh erosion remains the number one complaint concerning transvaginal mesh implants. Statistics indicate that approximately 40 percent of the women experiencing post surgical problems revolve around erosion. The condition entails a gradual deterioration of the mesh. Device fibers then become embedded in tissue or tissue grows around the mesh, which causes inflammation, infection and pain. Erosion also hinders intimacy.
Organ perforation is another common problem and occurs when the mesh deteriorates and sheds fibers into organs or when internal pressure forces the mesh into organs. Patients then suffer bleeding, infection and long-term injuries because of the difficulty involved with attempting mesh removal. The erosion and perforation may also occur between the vagina and rectum creating a fistula, or opening between the two passageways.
Transvaginal mesh features the vinyl mesh component and an animal tissue component. The animal tissue portion, usually derived from bovine, often shrinks up to 20 percent following implantation, which causes tissue damage and pain. Patients may also experience recurrent prolapse when the mesh fails or surgeons insert the device improperly.
Mesh complications typically require multiple corrective surgeries in attempts at removing the mesh and repairing damaged tissue. The extent of internal damage may necessitate a hysterectomy under certain circumstances.