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SPARC Mesh Recall and Lawsuit FAQs

Women who have given birth may experience involuntary loss of urine when they sneeze, cough, laugh or exercise. This medical condition is called stress urinary incontinence (SUI). SUI is usually treated by implanting transvaginal mesh to support the bladder and pelvis and prevent urine leakage. For more than a decade, American Medical Systems’ SPARC mesh implant has been used to treat SUI in women. Unfortunately, many women have suffered severe health complications related to their SPARC mesh implant.

Q: Has there been a SPARC mesh recall?

While SPARC mesh implants haven’t yet been recalled, a SPARC mesh recall may occur in the future. The SPARC mesh is based on another transvaginal mesh that can be traced back to Boston Scientific’s recalled ProteGen sling. Thousands of ProteGen slings were recalled due to higher than expected rates of mesh erosion through the vaginal wall. Numerous women who have the SPARC mesh implant claim experiencing mesh erosion. If mesh erosion is left untreated, serious complications may occur.

Q: What are the types of health issues you may experience?

The FDA has received numerous complaints relating to transvaginal mesh implants used to treat SUI. According to the FDA, mesh erosion is a common complication. This occurs when the mesh implant deteriorates and breaks into pieces. The sharp edges of these mesh fragments can cause vaginal bleeding, discharge, infection, pain, and discomfort during intercourse. Since soft tissue often becomes entwined in the mesh, treatment of mesh erosion generally requires multiple surgeries.

In addition to mesh erosion, women who have transvaginal mesh implants have reported a number of other health issues including:

  • Scarring of the Vagina
  • Discomfort during Sexual Intercourse
  • Vaginal Infection
  • Vaginal Bleeding
  • Urinary Problems
  • Recurrent Incontinence
  • Organ Perforation
  • Neuromuscular Issues

Some of these medical conditions may require hospitalization and surgery.  Consequently, you should see your doctor if you experience any of the above complications.

Q: Are there lawsuits related to the SPARC mesh implant?

Thousands of women have filed lawsuits alleging they suffered adverse health consequences related to the SPARC mesh implant and other transvaginal mesh implants sold by American Medical Systems. Many of the lawsuits have been consolidated into a multidistrict litigation matter in the U.S. District Court for the Southern District of West Virginia. There are also numerous lawsuits pending in various states.

Q. Do I have a legal claim against American Medical Systems?

The lawsuits involving transvaginal mesh are usually based on product liability law and, in some instances, medical malpractice as well. Under the doctrine of product liability, manufacturers and sellers of medical devices have a duty to make sure their products are safe for patients. If they breach this duty, they could be liable for any injuries that result from a defective medical device.

A medical device may be defective due to a faulty design that makes the product dangerous for patients. In lawsuits involving SPARC mesh implants, the plaintiffs typically argue that the implants have a dangerous design defect because the mesh erodes at a high rate, causing serious injuries to patients. Plaintiffs may also contend that the manufacturer should have removed its implant from the market by implementing a SPARC mesh recall.

Manufacturers also have a duty to disseminate adequate warnings about the risks associated with their products. Plaintiffs have claimed that American Medical Systems failed to provide adequate warnings about the complications related to the SPARC mesh. Furthermore, doctors who failed to warn women about the possible complications of the SPARC mesh implant or implanted it incorrectly could be liable under a medical malpractice law. If a jury finds for the plaintiff at trial, she could be awarded damages for lost earnings, medical expenses, and pain and suffering related to her injuries.

Q. If I have a transvaginal implant, what should I do?

If you’ve experienced health issues related to your implant, you should first find out the type of implant you have. If you have a SPARC mesh implant, you should contact an attorney to learn more about your legal options. If you do choose to file a legal claim, it may put additional pressure on the manufacturer to implement a SPARC mesh recall and prevent further injuries. Finally, it’s important to note that a statute of limitations generally limits the time you have to file a lawsuit.