Thousands of women that have undergone transvaginal mesh placement procedures in order to repair pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”) have suffered serious injuries due to the use of poorly-designed and inadequately-tested mesh devices.
In fact, no less than 7 separate mesh manufacturers’ products have come under scrutiny by the U.S. Food and Drug Administration (FDA) since women began reporting problems in increasing numbers starting in 2005. These manufacturers include well-known brand names like American Medical Systems, Inc., Boston Scientific, C.R. Bard, Inc., and Johnson & Johnson, among others.
At Zehl & Associates, our personal injury lawyers have helped hundreds of women hold the manufacturers of defective transvaginal mesh devices responsible for the harm they have caused. That means forcing Defendants to fully compensate our clients for all of their harms and losses, including money to cover medical bills, future medical costs, pain and suffering, physical impairment and much more.
If you or your loved one have undergone one of these procedures and developed serious health problems as a result, contact the experienced mesh injury lawyers at Zehl & Associates today for a free consultation by dialing 1-888-318-6576 or by clicking here.
Problems Associated with Transvaginal Mesh
Because defective mesh devices can begin to shrink or deteriorate inside the body in as little as just a few weeks or months, serious health problems will often manifest within a relatively short period of time after the procedure. These side effects may include:
- Pain during urination;
- Pain during sexual intercourse;
- Lower back pain;
- Vaginal bleeding;
- Urinary incontinence;
- Prolapsed organs; and
If you or your loved one are experiencing any of the above side effects following implantation of a device, seek medical attention immediately!
FDA’S Timeline of Transvaginal Mesh Warnings and Recalls
Oct. 20, 2008 — The FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina, or transvaginally, to treat POP and SUI.
July 13, 2011 — Based on further analysis of adverse events reported and complications described in relevant scientific literature, the FDA issued an update identifying the use of surgical mesh for transvaginal repair of POP as “an area of continuing serious concern.”
According to the FDA, this update was issued to “inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”
August 3, 2011 — The FDA issued a Class 2 transvaginal mesh recall of Boston Scientific’s devices, the Anterior/Apical and Posterior STERILE Pinnacle Pelvic Floor Repair Kits.
While an FDA advisory panel has so far refused to issue an outright recall of all transvaginal mesh devices, it has recommended tougher pre-market evaluation of these devices as well as reclassifying them as Class 3 devices — the highest-risk classification in existence.
If you have any questions or concerns regarding the devices or your rights and remedies, do not hesitate to contact Zehl & Associates in order to speak with one of our experienced surgical mesh injury lawyers, at no cost to you, by dialing 1-888-318-6576 or by clicking here.
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