Transvaginal Mesh Recall
Transvaginal mesh is used to repair pelvic organ prolapse and stress urinary incontinence. Though there were high expectations for mesh when it was first approved for market, there have since been some issues experienced by users – some of them serious. So far, the FDA has not issued any recall for transvaginal mesh products, nor have any manufacturers chosen to perform an all-encompassing voluntary recall. However, some manufacturers stopped making specific models of mesh products after consumers who experienced problems took legal action against the companies.
FDA Takes a Closer Look at Transvaginal Mesh
In 2011, the FDA held an advisory committee meeting of 15 people who listened to testimony from medical professionals who dealt with mesh complications firsthand. It was this panel that officially decided against a recall, but it did consider reclassifying mesh as a Class III device, which would trigger pre-market testing requirements. In 2014, the FDA submitted to proposed orders for reclassification, which are still waiting to be finalized.
Despite the lack of recall, the FDA did issue post-market surveillance orders (522 orders) in 2011 to all mesh manufacturers. In response, additional manufacturers pulled their products from the market. Unfortunately, the FDA action came too late for many women who experienced complications that ranged from infection and bleeding to mesh erosion and cutting of their vaginal walls.
In response to the complications and the perceived lack of dramatic action by the FDA, some consumer advocacy groups are calling for a complete ban on mesh products. Many believe there wasn’t enough testing performed on mesh implants before they were approved and they believe there is no clinically significant benefit to support the use of transvaginal mesh. They consider the use of mesh to repair pelvic organ prolapse is unethical.
Manufacturers Who Have Ceased the Manufacturing of Transvaginal Mesh
Some manufacturers, without orders from the FDA, have stopped transvaginal mesh production and recalled some of their products. Among those stopping production and issuing voluntary recalls include:
Boston Scientific, makers of the first transvaginal mesh product, voluntarily recalled its ProtoGen device in 1999, marking the first recall issued for transvaginal mesh. It had only been on the market for three years when the recall was issued.
Johnson & Johnson and Ethicon
Johnson & Johnson and its Ethicon unit ceased sales of its Gynecar line of mesh products midway through 2012. The move was in response to lawsuits filed against the company by more than 600 women regarding four products, including the Gynecare Prolift Kit, the Gynecare TVT Secur, the Gynecare Prolift + M Kit, and the Gynecare Prosima Pelvic Floor Repair System Kit.
The stoppage in sales was not an official recall of devices already sold or implanted. Ethicon has also not ended all mesh device production and continues to sell its Gynecare Gynemesh with updated labeling to not the dangers of using the product for abdominal implantation.
C.R. Bard Inc.
C.R. Bard joined the sales stoppage in 2012 when it stopped selling its Avaulta Plush mesh. This came after a jury had ruled an injured plaintiff should receive $5.5 million after she was forced to undergo eight surgeries to repair damage caused by her mesh device. The verdict included half a million dollars awarded to husband due to the effect the event had on the couple’s sex life.
Supporters of Transvaginal Mesh
Despite the specific reports of complications, there are still some who believe a recall is unnecessary and that transvaginal mesh is a useful medical product. The American Urogynecologic Society’s official stance on the mesh is that the decision of whether to use it or not should be between a woman and her physician, without interference from the FDA. Instead, they believe there should be stricter credentialing guidelines, so surgeons advising a woman of the pros and cons of the mesh are fully qualified.
Mesh Manufacturers Face Mountain Legal Action
Six of the major manufacturers of mesh devices face lawsuits related to the patient injury. More than 22,000 lawsuits were combined into six multi-district litigation cases, and there are thousands of more individual suits in the process of being filed in state courts across the country.