A California woman is suing Boston Scientific claiming the company’s transvaginal mesh implant caused her excessive and unnecessary complications.

Plaintiff Laurel S. says that in November 2010 she was implanted with the Advantage Transvaginal Mid-Urethral Sling System, a product of defendant Boston Scientific Corp.

She is now bringing a claim over complications she says she experienced following that implantation.

Laurel’s transvaginal mesh implant lawsuit is part of a multidistrict litigation pending in a federal court in West Virginia. This MDL is a consolidation of several individual lawsuits similar to Laurel’s.

According to the MDL’s master long form complaint, the transvaginal mesh implant was developed based on materials that had been used for decades to repair abdominal hernias.

Gynecologists began adapting these implantable materials in the 1990s to treat pelvic organ prolapse and stress urinary incontinence.

In pelvic organ prolapse, weakened muscles inside the abdomen fail to support the surrounding organs and allow them to descend. Pelvic mesh implants are used to compensate for the muscle weaknes and to hold these organs in place.

Stress urinary incontinence can also be remedied by an implantable sheath that holds the urethra and bladder neck closed, preventing them from leaking.

Today, defendant Boston Scientific sells several different transvaginal mesh implant kits consisting of the mesh itself, fixation anchors and insertion tools. Several of these kits are at issue in the current MDL, including the Advantage Transvaginal Mid-Urethral Sling System that Laurel was implanted with.

Plaintiffs in the MDL allege that these Boston Scientific products are defective and dangerous as designed.

Among other complaints, they say the implants are made of polypropylene that is biologically incompatible with human tissue. They allege this polypropylene stimulates a negative immune response leading to inflammation of the surrounding tissue.

Some of the products at issue are made with collagen, which the plaintiffs also say is not a suitable material. While these collagen components supposedly dissolve after implantation, plaintiffs say they cause a hyper-inflammatory response that can lead to chronic pain and fibrotic reaction.

The plaintiffs suggest that Boston Scientific exploited an expedited FDA approval process to avoid putting their mesh implants through the usual round of testing and clinical trials required for medical device approval.

FDA: Transvaginal Mesh Implant Complications “Not Rare”

The plaintiffs also cite an FDA safety communication from July 2011 warning the public and the medical community that transvaginal mesh implant complications are “not rare.”

The communication points out that reports made to the FDA and published in scientific literature say these devices are at risk for shrinking after they are implanted. The reports associate this shrinkage with “vaginal shortening, vaginal tightening and vaginal pain,” according to the FDA.

Plaintiffs argue that, given the available scientific evidence, Boston Scientific was on notice that these devices were causing excessive complications. Nevertheless, the company continues to market these products as a safe and effective way to treat pelvic organ prolapse and stress urinary incontinence.

Plaintiffs say Boston Scientific made a point of omitting and downplaying the risks in its promotion of these products.

The Transvaginal Mesh Implant Lawsuit is Case No. 2:16-cv-06087 filed within In Re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, MDL No. 2326 in the U.S. District Court for the Southern District of West Virginia.