New information continues to underscore that these vaginal mesh products are a bad idea. New data suggests that transvaginal bladder suspension surgery utilizing non-absorbable surgical mesh incurs a high risk of permanent injury and provides no significant benefits. So the pain of this surgery and the difficulties these women have faced may have been for naught across the board? It is incredible.
In a recent Safety Communication, the FDA expressed more concern about the potential safety risks of using transvaginal surgical mesh to treat pelvic organ prolapse. The FDA has targeted the medical device as an area of “continuing serious concern.” This warning follows a similar warning issued by the FDA in 2008. Since then, the agency has received 1,503 adverse event reports associated with the use of transvaginal surgical mesh to repair pelvic organ prolapse, nearly five times as many as it received between 2005 and 2007. From this, you will see a lot of vaginal mesh lawsuits coming down the pike.
In response, the Washington, D.C.-based consumer watchdog group Public Citizen – who has gotten out in front of a lot of these types of problems – has urged the FDA to go beyond their warnings and recall transvaginal mesh in an effort to prevent unnecessary exposure to a device that has the potential to cause serious adverse complications. In their petition, Public Citizen demands three specific actions from the FDA:
1) place an outright ban on the marketing of all currently available non-absorbable surgical mesh products designed and labeled for transvaginal repair of pelvic organ prolapse;
2) order all manufacturers of these products to issue a recall thereof; AND
3) require that any future surgical mesh devices designed to treat pelvic organ prolapse be classified as a Class III device, a process that requires a stringent approval process. Many surgical mesh products currently on the market went through the FDAs expedited 510(k) review process, an accelerated method of approval that only requires a medical device to be significantly equal to one already on the market.
The surgical mesh in question is a non-absorbable synthetic material permanently implanted onto existing tissue to reinforce the vaginal wall. It is used to repair pelvic organ prolapse or as a sling to support the bladder and relieve urinary incontinence.
Several lawsuits have been filed on behalf of women in the United States who have experienced a serious adverse event or injury because of transvaginal surgical mesh. Common adverse events reported with the use of surgical mesh to repair pelvic organ prolapse include:
• mesh protrusion through the vagina
• organ perforation
• urinary problems
• recurrent prolapse
• vaginal scarring
We are looking at the following types of vaginal mesh cases:
* Bard Avaulta Support System
* AMS Elevate Prolapse Repair System
* AMS Apogee Vault Suspension System
* AMS Perigee System
* AMS Monarc Sling System
* AMS Sparc Sling System
* Ethicon Gynecare Gynemesh
* Ethicon Gynecare Prolene Soft Mesh
* Ethicon Gynecare Prolift Pelvic Floor Repair System
* Ethicon Gynecare TVT Transvaginal Sling
* Boston Scientific Pinnacle Pelvic Floor Repair Kit
* Boston Scientific Uphold Vaginal Support System
* UGYTEX Dual Knit Mesh
* Coviden IVS Tunneler Sling