As far back as 2007, Johnson & Johnson had been warned by the Food and Drug Administration (FDA) to discontinue marketing its Gynecare Prolift® transvaginal mesh (TVM) implant. The vaginal mesh is a device used to treat stress incontinence. Women who have this condition must contend with involuntarily bladder leakage brought about by weak uterine wall muscles. The urine discharge usually occurs when affected women sneeze, laugh or engage in a similar activity that uses these muscles in the body. Several manufacturers in addition to Johnson & Johnson have created vaginal meshes that have had serious side effects for women.
Continuing sale in spite of FDA warning
When Johnson & Johnson received the letter of reprimand from the FDA, it chose to ignore it and continued to sell these defective products for another nine months. When the company did finally discontinue producing and selling the Gynecare Prolift vaginal mesh implant, it was due to declining profits and not concern over women’s health risks. Unfortunately, the FDA lacked the power to sanction Johnson & Johnson for deliberately defying the mandates of its reprimand. However, the FDA did issue a warning to all users of the transvaginal mesh in June of 2011. This warning was prompted by complaints about numerous other manufacturers and different types of mesh slings.
Phillips Law Offices in Chicago is available to evaluate your claim if you have been injured by a defective transvaginal mesh product. There are several possibilities for claims, including manufacturing and design defects, failure by manufacturers and doctors to warn women of the risks, and more. Our team of experienced medical malpractice lawyers focuses on TVM cases, and we thoroughly research the facts in your case in order to determine whether a product liability lawsuit can be filed on your behalf. It is our goal to get you the compensation you need to cope with added medical expenses and unnecessary pain and suffering.