FDA Orders Medical Device Manufacturers to Stop Selling Transvaginal Mesh Surgical Products

FDA Orders Medical Device Manufacturers to Stop Selling Transvaginal Mesh Surgical Products

The U.S. Food and Drug Administration has ordered Boston Scientific and Coloplast medical device companies to stop selling trans vaginal mesh, also known as pelvic mesh or bladder sling, products used for the transvaginal repair of pelvic organ prolapse and stress urinary incontinence. [Read more…]

Nearly 350 Pelvic Mesh Lawsuits Against Boston Scientific Settled

Nearly 350 Pelvic Mesh Lawsuits Against Boston Scientific Settled

Nearly 350 lawsuits included in multidistrict litigation against Boston Scientific Corp. over defective pelvic mesh implants have been settled by a West Virginia federal judge. The case involves seven MDLs composed of 28,000 individual cases against Boston Scientific and other makers of mesh implants, such as American Medical Systems, C.R. Bard Inc., and Johnson & Johnson. [Read more…]

New Zealand Becomes First Major Country to Ban Vaginal Mesh Implants

New Zealand Becomes First Major Country to Ban Vaginal Mesh Implants

New Zealand has become the first major country to effectively ban surgical mesh implants for all pelvic operations in response to safety concerns and reported mesh hazards. The order from the country’s Ministry of Health is intended to force mesh suppliers to stop marketing the mesh products or prove that they are safe to use. [Read more…]

Johnson & Johnson Pays $120 Million Settlement in Surgical Mesh Lawsuit

Johnson & Johnson $120 Million Settlement in Surgical Mesh Lawsuit

Medical device manufacturer Johnson & Johnson (J&J) has agreed to pay a $120 million settlement to the 2-3,000 women who filed injury lawsuits claiming to have suffered organ damage and constant pain from allegedly dangerous and defective surgical mesh. As reported by Bloomberg, these “settlements mark the first time J&J and its Ethicon unit have agreed to resolve a significant number of mesh cases.” [Read more…]

FDA Classifies Transvaginal Mesh as High-Risk due to Serious Complications from Surgery

FDA Classifies Transvaginal Mesh As High Risk

The U.S. Food and Drug Administration (FDA) has reclassified the surgical mesh device utilized for transvaginal repair of pelvic organ prolapse (“POP”) and other conditions in women as a high-risk (class III) product. Previously, the agency classified the product as moderate-risk (class II). [Read more…]