On Tuesday, the Food and Drug Administration (F.D.A.) ordered Boston Scientific and Coloplast cease all sales and distribution of hernia mesh devices used for the repair of pelvic organ prolapse. Following years of ongoing legal conflict, Boston Scientific and Coloplast were the only companies still selling and distributing the surgical mesh product.
Historically, pelvic mesh, also known as transvaginal mesh, has been the subject of litigation from the earliest days of its use in the United States. By many estimates, the lawsuit is one of the largest mass tort cases in U.S. history, affecting the lives of more than 100,000 women. As more women came forward about their injuries, it became increasingly difficult for the F.D.A. to ignore the injuries caused.
Transvaginal mesh was intended to provide a means of strengthening muscles in the pelvis that, when weak, can allow for organs to sag into the vaginal area. However, it became evident that the device was not nearly as safe nor as effective as the manufacturers had claimed.
Hernia Mesh Device History
For many years, patients complained of the device causing more harm than they initially warnings suggested. Injuries observed after a mesh implant surgery included severe pain, dangerous infections, adhesion of the mesh to other tissue, recurrence of the original hernia, perforation of internal organs, and many more.
Attorneys and advocates responded to these growing concerns by filing suit against the device manufacturers and petitioning the F.D.A. to believe that the hernia mesh implants cause significant harm. In 2016, the F.D.A. started listening to these concerns, reclassifying the devices as high risk and instructing the device manufacturers to provide additional evidence of the safety and efficacy of the products.
F.D.A. Action Against Surgical Mesh
This brings us to the current chapter of the ongoing pelvic mesh story where the FDA has determined that these companies have failed to produce such evidence and thus the device cannot be determined to be safe for use.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse,” said Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health. The F.D.A concluded that they “… couldn’t assure women that these devices were safe and effective long term.”
In light of the F.D.A.’s action on hernia mesh devices, attorneys and advocates continue to press for the F.D.A. to consider taking action against the wider applications of the device, such as its use in the treatment of urinary and stress incontinence.
Boston Scientific expressed disappointment with the F.D.A.’s announcement.Boston Scientific and Coloplast commented that sales of their hernia mesh devices accounted for no more than 1% of their portfolios.
The unfortunate story of pelvic or transvaginal mesh repair devices is sadly one of greed and recklessness as corporations continue putting profits ahead of the safety and wellbeing of people. Too often, we see companies in these situations release dangerous, sometimes deadly, devices with the confidence that they will make exorbitant sums of money relative to the lawsuits and penalties that they will face by the time that justice catches up to them.
Contact a Hernia Mesh Lawyer
If you or a loved one have suffered following the implant or removal of a hernia mesh device, options for recovery may be available. Please contact our law firm as soon as possible to discuss your potential hernia mesh lawsuit and learn more about how our award-winning attorneys can help protect your legal rights.
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