Court proceedings in an Australian class action lawsuit against Johnson & Johnson and its subsidiary, Ethicon, have revealed that the company tried to squash a report that would’ve revealed more testing was needed to ensure the efficacy and safety of its pelvic mesh devices. The report also stated that Ethicon pelvic mesh should not be used in patients until a randomized, controlled study was conducted. Pelvic mesh is used to support parts of the female anatomy that can shift from pregnancy, childbirth, or other conditions and requires implantation by a skilled surgeon. Members of the class action lawsuit have suffered injuries including intense pain, reduced sex lives, and loss of livelihood.
An attorney for the women has said that Ethicon received the report by French health authorities in 2007, two years after the devices were already in use throughout Australia. Despite the report, the company put forth a marketing campaign that focused on the low price point and ease of implantation, while also going to great lengths to cover up the report from becoming public. Attorneys for the women have argued that implantation of pelvic mesh requires an advanced surgical technique, well beyond the skill level of a newer or inexperienced surgeon.
Earlier this month, the court heard minutes from an Ethicon meeting in which executives said the release of the French report “could have a major impact on our business if made public” and that efforts should be made to prevent it from becoming public. Court proceedings also discussed Ethicon’s involvement in a 2011 New England Journal of Medicine study and article touting the benefits and safety of their pelvic mesh devices. In 2013, the journal had to print an apology to its readers for misleading them on Ethicon’s involvement in the study and the article. Ethicon had essentially created the study, including the development of the study protocol, and had paid the authors of the article for their time. The company was also able to review the article draft before it was submitted and made numerous and significant changes.
Pelvic Mesh Devices for Pelvic Organ Prolapse Reclassified to High Risk by FDA
According to the Mayo Clinic, pelvic mesh devices are most commonly used for pelvic organ prolapse or stress urinary incontinence. Last year, after receiving numerous complaints and reports of difficulty during surgical implantation and recovery, the Food and Drug Administration reclassified pelvic mesh devices used for pelvic organ prolapse from class II (moderate) to class III (high-risk).
Over 70,000 lawsuits are currently pending against manufacturers of surgical mesh due to complications. If you have suffered adverse reactions as a result of receiving a pelvic mesh device, please contact us for a free consultation with one of our experienced injury attorneys.
See Related Posts: