American Medical Systems is facing more than 5,000 lawsuits from women who were seriously injured by the SPARC Sling and other vaginal meshes. This implant is supposed to treat incontinence by supporting the bladder and urethra like a hammock. Unfortunately, it has been linked to high rates of erosion, infection, chronic pain, organ damage, and the need for excision surgery. These complications can be devastating and permanent. Furthermore, it is not clear that the SPARC Sling provides any patient benefits over non-mesh treatment of incontinence.
Do I have a SPARC Sling Lawsuit? If you or your loved one was injured by vaginal mesh, contact our law firm immediately for a free case consultation. If you file a lawsuit, you could receive compensation for your injury, medical expenses, and more.
What is the SPARC Sling?
The SPARC Sling System is a type of polypropylene transvaginal tape manufactured by American Medical Systems. The “hammock-like” design treats stress urinary incontinence (SUI) by supporting the urethra, which prevents bladder leakage when a woman coughs, sneezes, laughs, or moves vigorously. Surgeons use minimally-invasive techniques to implant the SPARC Sling around the urethra, utilizing one transvaginal incision in the vagina and two small incisions in the abdomen. Specially-designed needles thread the SPARC Sling into a U-shape under the urethra without tension.
Risks of the SPARC Sling
The U.S. Food and Drug Administration (FDA) has published multiple Safety Communications about the risks of vaginal mesh. The agency has received thousands of adverse event reports and continues to receive new reports of women who were seriously injured by complications, including:
- Tissue reaction to synthetic mesh
- Fistula formation
- Pain (may be chronic or only during sexual intercourse)
- Organ perforation (blood vessels, intestines, bladder, etc.)
- Mesh contraction of shrinkage
- Erosion into the bladder or urethra
- Protrusion of the sling into the vagina
- Loss of consortium with spouse
- Device migration
- Complete failure of the procedure, resulting in incontinence
- Need for additional surgery
- And more
SPARC Sling “Equivalent” to Recalled ProteGen Vaginal Mesh
The SPARC Sling System was approved by the U.S. Food and Drug Administration (FDA) in August 2001. American Medical Systems submitted a 510(k) application, which allows manufacturers of new devices to avoid rigorous safety studies if there is a “substantially equivalent” device that already has FDA approval. The “equivalent” product for the SPARC Sling was the Ethicon / Gynecare TVT (Tension-Free Vaginal Tape). The TVT was approved in 1998 with a 510(k) application based on its equivalence to the ProteGen Sling, manufactured by Boston Scientific in 1996.
Unfortunately, the ProteGen was recalled in 1999 due to safety concerns — two years before the SPARC Sling was approved. Although dozens of vaginal meshes can trace their design back to the ProteGen, the FDA continued approving new products without requiring new safety studies. Not surprisingly, many women who were implanted with the SPARC Sling and other “equivalent” products have suffered from the same devastating complications.
American Medical Systems Faces Federal Multi-District Litigation (MDL)
American Medical Systems is currently facing a federal Multi-District Litigation (MDL) involving many SPARC Sling lawsuits. By March 2013, more than 5,000 lawsuits were filed in MDL No. 2335 in the U.S. District Court for the Southern District of West Virginia, before Judge Joseph R. Goodwin.
Many lawsuits allege that AMS was negligent for failing to adequately design, test, or warn about the risks of the SPARC Sling before marketing it to women. If you were injured by this implant, you may still have time to file a SPARC Sling lawsuit in the MDL and seek justice for your injuries, which may include:
- Pain and suffering
- Past and future medical expenses
- Lost income
- Permanent injuries
- Loss of consortium with your spouse
- Punitive damages
Do I Have a SPARC Sling Lawsuit?
The Product Liability & Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in vaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new lawsuits in all 50 states.
Free Vaginal Mesh Lawsuit Evaluation: Again, if you or a loved one was injured by the SPARC sling, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.