A woman has filed a vaginal mesh lawsuit against Boston Scientific and C.R. Bard, alleging the transvaginal mesh and sling system has caused her injuries.

Plaintiff Debra V. said she underwent surgery in June 2016 for implantation of transvaginal mesh devices to treat her pelvic organ prolapse and stress urinary incontinence.

Nearly two months later, Debra says she had a revision surgery to address complications from the mesh, which allegedly included pain, more urinary problems and painful sexual intercourse.

Since then, Debra alleges in the vaginal mesh lawsuit that the product continues to cause her to suffer serious pain, discomfort, pressure, difficulty voiding urine, continued incontinence, painful intercourse and loss of enjoyment of life.

Vaginal Mesh Lawsuit Alleges Problems Were Known

Debra and many other plaintiffs allege problems with the mesh were known by the manufacturers, who continued to make and sell the products anyway.

The vaginal mesh products allegedly contain monofilament polypropylene mesh and/or collagen. According to Debra’s vaginal mesh lawsuit, research has indicated polypropylene is not biologically compatible with human tissue, which generally reacts by rejecting the material. Inflamed pelvic tissue is then more susceptible to other adverse mesh reactions.

The vaginal mesh lawsuit contends the “collagen products cause hyper-inflammatory responses leading to problems including chronic pain and fibrosis.”

While the collagen products allegedly disintegrate after implantation, Debra says they are prone to causing adverse tissue reactions and often cause infection because the collagen allegedly is derived from animal tissue.

“Animal collagen is harsh upon the female pelvic tissue. It hardens in the body,” says the vaginal mesh lawsuit. This animal collagen allegedly can cause chronic pain and functional problems related to urination.

The FDA said it received more than 1,000 adverse event reports related to vaginal mesh devices between 2005 and 2007. Between 2008 and 2010, the FDA received more than 2,800 adverse event reports of complications, including mesh erosion through the vagina, infection, pain, bleeding, painful sex, organ perforation and urinary difficulties. In many cases, additional surgery and treatments allegedly were needed.

Despite the fact the FDA issued a Safety Communication in July 2011 indicating the benefits of using transvaginal mesh products may not outweigh the risks, the manufacturers of pelvic mesh products allegedly continued to aggressively market the materials as safe and effective treatment options.

According to the FDA, even with surgery for vaginal mesh complications, “Complete removal of mesh may not be possible.”

Pelvic Mesh Settlements Worth Tens of Millions

Women have reached pelvic mesh settlements in the tens of millions of dollars. Boston Scientific reached a $457 million pelvic mesh settlement in October 2015 with multiple plaintiffs who had filed vaginal mesh lawsuits. More than 20,000 vaginal mesh lawsuits have been filed against Boston Scientific.

C.R. Bard agreed to a $200 million pelvic mesh settlements in August 2015 to bring resolution to approximately 3,000 lawsuits. C.R. Bard still faces more than 10,000 vaginal mesh lawsuits.

The Vaginal Mesh Lawsuit is Case No. 2:18-cv-02970-MAK in the U.S. District Court for the Eastern District of Pennsylvania.