U.S. Food and Drug Administration (FDA) approval process for medical devices was in the spotlight in a recent PBS “Need to Know” episode earlier this March. The program questioned whether the review process in place by the FDA is adequately protecting people.
PBS’s medical correspondent focused the “Need to Know” episode on pelvic mesh products or transvaginal mesh (TVM), as it is also known. The pelvic mesh products are used to treat conditions like incontinence and pelvic organ prolapse, a condition where organs can sag into the vagina.
The FDA fast tracked the TVM products on the basis that pelvic mesh products were “substantially equivalent” to other products already on the market. Then in 2011, the FDA gave warnings that women were reporting injury and complications from the transvaginal mesh products.
Many women who underwent surgeries to help with their conditions of incontinence or pelvic organ prolapse have suffered a range of conditions resulting from TVM implants, including severe pain, revision surgeries, and total disability.
The legal professionals Solberg Stewart Miller in Fargo, ND recommend that women who have questions about pelvic mesh products, safety, or injuries they have suffered as a result of this medical product should consult with an attorney. At Solberg Law Firm, the attorneys are specialized in personal injury, medical malpractice, product liability and medical devices. They are prepared to answer your questions and help you navigate the legal process while you focus on your health. Call them at 701.237.3166 or toll free at 877.237.3166.