If you were seriously injured by SPARC mesh, you are not alone — more than 5,000 lawsuits have been filed against American Medical Systems involving this mesh implant and others. Although it is supposed to treat stress urinary incontinence by supporting the bladder and urethra, SPARC mesh has been linked to serious problems. Complications can include erosion, infection, organ perforation, chronic pain, incontinence, additional surgery, and more.
Free SPARC Mesh Lawsuit Evaluation: If you or your loved one was injured by SPARC 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.
American Medical Systems manufactures the SPARC Sling System, an implant made of polypropylene (plastic) fibers that are woven into a long, narrow strip of mesh. It is a type of transvaginal mesh that is implanted with one incision in the vagina and two incisions in the abdomen.
Once in is secured to the pelvis in a “U”-shape, it resembles a hammock under the bladder. SPARC mesh supports and strengthens weakened muscles in the pelvic floor, which helps prevent the urethra from dropping down and leaking urine.
What is the problem with SPARC mesh?
Although SPARC mesh is advertised as a minimally-invasive outpatient procedure, this implant should be considered a “major surgery” with a serious risk of complications. One of the most serious risks is organ damage during the implantation procedure. Surgeons who implant SPARC mesh must blindly pass a needle downward through the retropubic space above the pubic bone, which can lead to perforation of blood vessels, bladder, and the intestines. Another serious risk is erosion of mesh through the vaginal wall, which is the most common complication.
The U.S. Food and Drug Administration (FDA) has also warned about the risks of mesh in Safety Communications in 2008 and 2011. According to the FDA, mesh surgery is no better than non-mesh surgery, but serious complications are “not rare”.
SPARC mesh complications can include:
- Adverse tissue reactions to synthetic mesh material
- Chronic pain
- Pain during sexual intercourse (dyspareunia)
- Organ damage
- Perforation of blood vessels, intestines, bladder
- Contraction or shrinkage of mesh
- Mesh erosion into the vagina, bladder, colon
- Additional surgery
- And more
SPARC Mesh Similar to Recalled Mesh Implant
The U.S. Food and Drug Administration (FDA) approved SPARC mesh in August 2001 based on a 510(k) application. This type of application allows the approval of a new device without requiring safety studies so long as it is “substantially equivalent” to a device that is already on the market.
The SPARC mesh 510(k) application cited the Ethicon Gynecare Tension-free Vaginal Tape (TVT), which had been approved in 1998 with a 510(k) application citing the Boston Scientific ProteGen Mesh, which had been approved in 1996 with a 510(k) application citing “hernia mesh” and a 90-day study of the mesh in rodents.
The ProteGen mesh was recalled in 1999. It was causing high rates of erosion and vaginal dehiscence (disembowelment through ruptured incisions in the vagina). Although the SPARC mesh can trace its design back to a recalled product, American Medical Systems had not recalled the SPARC mesh. Now, many women allege that the implant is unsafe and they were never warned about the potential risk.
SPARC Mesh Lawsuits in Federal Litigation
American Medical Systems is facing more than 5,500 lawsuits involving SPARC mesh and other mesh products. These lawsuits have been centralized in a federal Multi-District Litigation (MDL) in the U.S. District Court for the Southern District of West Virginia:
SPARC mesh lawsuits could be awarded compensation for:
- Pain and suffering
- Past and future medical expenses
- Lost income
- Permanent injuries
- Loss of consortium with your spouse
- Punitive damages
Need a SPARC Mesh Lawyer?
The Product Liability & Defective Medical Device Litigation Group at our law firm is an experienced team of trial attorneys that focus on the representation of plaintiffs in SPARC mesh lawsuits. We are handling individual litigation nationwide and currently accepting new lawsuits in all 50 states.
Free SPARC Mesh Lawsuit Evaluation: Again, if you or a loved one was injured by SPARC mesh, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.