After several years, thousands of complaints and hundreds of personal injury lawsuits, Johnson & Johnson has decided to stop selling its vaginal mesh products that are used to repair pelvic organ prolapse or stress urinary incontinence in women. The company announced the decision in a letter to the judges overseeing court cases against the company.
The letter, which was delivered early last week, states that the company plans to phase out its four vaginal mesh products over the next four months. The announcement came soon after court records were made public that suggest Johnson & Johnson continued to sell the product for nine months after federal regulators ordered the company to stop production.
The Food and Drug Administration issued a warning last year stating that the vaginal mesh products could carry a higher risk of pain, bleeding and infection than other forms of treatment. This was after the FDA received more than 3,000 “adverse event reports” of pain, tissue erosion, infection, bleeding, organ perforation and enhanced urinary problems from women who had the mesh products implanted in their bodies.
Last July, the FDA urged doctors to use other means to treat organ prolapse and stress urinary incontinence. Additionally, the FDA ordered 33 mesh manufacturers to conduct three-year safety studies on the products. Johnson & Johnson admitted that it hopes to avoid conducting the research by getting rid of the product altogether.
More than 1,000 lawsuits have been filed throughout the country against the manufacturers of the vaginal mesh products. The lawsuits, many of which have been consolidated, allege that the manufacturers knew the vaginal mesh products were dangerous and failed to warn hospitals and consumers.
Source: Associated Press, “J&J to stop selling pelvic mesh tied to lawsuits,” June 5, 2012; Bloomberg News, “Johnson & Johnson kept selling vaginal mesh implants after warnings,” June 26, 2012