Companies are not permitted to indulge in false, wrong, deceptive, unfair, or misleading acts or practice. Attorney General of Kentucky, Andy Beshear, has filed a civil lawsuit against Johnson & Johnson (J&J) and Ethicon, their medical device unit, for allegedly misrepresenting its surgical transvaginal mesh.
Companies are not permitted to indulge in false, wrong, deceptive, unfair, or misleading acts or practice in commerce or trade, according to Kentucky’s Consumer Protection Act.
Transvaginal mesh is made of a synthetic woven fabric that is implanted in women for the treatment of common pelvic floor problems that are reportedly experienced by 30 percent to 50 percent of women.
When the muscles and tissues of the pelvic floor can no longer support pelvic organs such as the bowel, bladder or uterus, the organs may drop from the normal position or prolapse into the vagina, and doctors may recommend implantation of the transvaginal mesh. Although not a life-threatening occurrence, women may experience low back pain, pelvic pressure, constipation, or urinary issues.
Women Receive Transvaginal Mesh Implantation
In Kentucky, more than 15,000 women have received implantation of transvaginal mesh. These women allegedly did not receive sufficient information from J&J and Ethicon regarding the known side effects or dangers associated with the device. This prevented the women, as well as their physicians, from having the opportunity of making informed treatment decisions, according to the lawsuit.
Beshear remarked that J&J did not obey the recommendations given by its own personnel regarding the addition of more complete risk-related warnings.
In 2005, over a decade ago, Johnson & Johnson’s medical director allegedly sent an email to the company proposing stronger product warnings for patients and physicians.
The email reportedly advised that initial clinical experience showed that transvaginal mesh usage may at times result in complications such as vaginal erosion and retraction. This may result in anatomical distortion of the vaginal cavity that can interfere with sexual intercourse.