Kentucky Attorney General Andy Beshear announced on August 16, 2016 that his office was filing a civil lawsuit against Johnson & Johnson and its medical device unit, Ethicon, over surgical mesh devices used in gynecological surgery.
The lawsuit alleges the companies used deceptive marketing for transvaginal mesh devices, television station WKYT reports.
Transvaginal mesh devices are implanted to treat women’s pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The products’ design and implantation technique can cause serious complications, such as erosion and organ perforation. Women report injuries and complications such as pelvic pain, painful sexual intercourse, protrusion of the mesh into the vagina, infections, urinary problems, bleeding, and recurrence of the prolapse or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion of transvaginal mesh.
The devices are implanted in women whose pelvic structures have weakened because of childbirth, surgery, or aging. The transvaginal mesh device provides support for the organs. But clinical studies have shown that one in 12 patients suffers complications from the device.
In Kentucky, the attorney general says, more than 15,000 women had transvaginal mesh implanted without the information they needed to make informed decisions. According to the lawsuit, Johnson & Johnson and Ethicon failed to give adequate information about the known hazards to women and their doctors, WKYT reports. “The way this company clearly chose profits over people is outrageous,” Beshear said. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”
Transvaginal mesh devices, which are based on the surgical mesh used in hernia repair, were approved by the Food and Drug Administration (FDA) in 1996 to treat urinary incontinence and in 2002 for the treatment of pelvic organ prolapse. When the pelvic structures that support the uterus, bladder and intestines weaken, the organs can drop (prolapse) into the vagina, causing incontinence and bowel and sexual problems. Transvaginal mesh devices are implanted to provide support for the organs.
A number of transvaginal mesh device manufacturers, including Endo, Johnson & Johnson, C.R. Bard, Boston Scientific, Cook Medical, and Coloplast Corp. are facing in lawsuits involving their transvaginal mesh products. Many women have needed additional surgery to attempt to remove the mesh. The surgery is not always successful, and the woman can experience repeated episodes of mesh erosion and surgery to removed protruding mesh. Women have even reported that their male partners have suffered injuries to their penises from protruding mesh.
The FDA proposes to reclassify of mesh devices from Class II (moderate risk) to Class III (high risk). As Class III devices, transvaginal mesh devices would be subject to a more stringent clearance process than what is currently required. The devices would have to undergo clinical trials to determine if they are safe and effective.