The Uphold Vaginal Support System by Boston Scientific caused a host of health problems, claims a woman whose lawsuit has joined a multidistrict litigation against the company.

Plaintiff Erika B. was implanted with the Uphold vaginal mesh in March 2014. The product is used to treat women suffering from either pelvic organ prolapse (POP) or stress urinary continence (SUI).

The Uphold Vaginal Support System contains monofilament polypropylene mesh and collagen. Even though polypropylene has been promoted as an inert ingredient, it “is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population implanted with the products,” according to the lawsuit.

Adverse reactions reportedly include inflammation of the pelvic tissue that can lead to chronic pain and fibrotic reaction in the form of scar tissue.

Collagen elements, made from animal or human tissue, can cause infection because the body rejects the material as foreign matter, leading to chronic pain and possible functional disabilities.

Uphold Vaginal Support System Can Misshape over Time

In July 2011, the FDA issued a statement saying “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”

The FDA went on to say that “[m]esh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.”

The FDA also has indicated the risks for women who have surgery that includes mesh do not necessarily experience improved clinical outcomes, and may be exposed to greater risks of complications.

The Uphold Vaginal Support System lawsuit alleges Boston Scientific did not adequately study the risks associated with the product. According to plaintiffs in the Boston Scientific multidistrict litigation, or MDL, the system suffers from these defects:

• The polypropylene and collagen cause immune reactions;
• Transvaginal insertion requires the mesh product to pass through an area of the body that contains “high levels of bacteria that can adhere to the mesh, causing immune reactions and subsequent tissue breakdown and adverse reactions and injuries;”
• The mesh contracts or shrinks after implantation, causing inflammation and fibrotic responses;
• Implantation procedures can injure major nerve routes within the pelvic area;
• The mesh can “creep” or gradually elongate or deform after implantation;
• The mesh can become entangled in sensitive areas of the vagina and pelvis, causing pain during normal activities such as walking, defecation, or intercourse.
• The mesh can degrade or fragment over time, causing chronic inflammatory and fibrotic reactions and injuries; and
• As the body rejects the mesh, chronic infections can occur.

According to the Uphold Vaginal Support System MDL, many women have been forced to endure operations to remove the mesh, “operations to attempt to repair pelvic organs, tissue, ad nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia.”

Surgical removal of the Uphold Vaginal Support System may require “multiple surgical interventions that result in scarring of compromised pelvic tissue and muscles if the mesh has eroded.

The Uphold Vaginal Support System Lawsuit is Case No. 2:17-cv-03884 in the U.S. District Court for the Southern District of West Virginia, Charleston Division, MDL No. 2326.