Connecticut Vaginal Mesh Lawsuit Cites Complications from AMS Monarch Sling

On December 14, 2012, a lawsuit was filed in the Connecticut District Court in New Haven against American Medical Systems, claiming vaginal mesh complications from the company’s Monarch sling. The lawsuit was brought by the woman who allegedly suffered the complications and her husband, who is suing for loss of consortium.

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Surgeons unable to remove mesh implant

According to the AMS transvaginal mesh lawsuit, the woman plaintiff was implanted with the Monarch sling in in July 2011 to treat her stress urinary incontinence. Subsequently she suffered complications including difficulty urinating, repeated urinary tract infections, vaginal pain and bleeding. Her complications were so serious that she needed to go to the emergency room on several occasions. Finally she underwent a second surgery to remove the Monarch sling, but surgeons were unable to entirely remove it, and so pieces of the mesh remain imbedded in her vaginal lining to this day.

The couple’s attorney claims that the Monarch sling has a defective design, is “not fit for purpose,” and was not adequately tested before being put on the market and implanted in patients. The couple is seeking damages for the wife’s injuries, and in addition, the husband seeks compensation for the “loss of his wife’s services, financial support. companionship, society and affection.”

Thousands of women have suffered complications from vaginal mesh implants

Vaginal mesh implants have a history of causing complications. From January 1, 2005 to December 31, 2007, the FDA received more than 1,000 adverse event reports about vaginal mesh devices.  From January 1, 2008 through December 31, 2010, another 2,874 vaginal mesh injuries were reported to the agency. In addition, there were three deaths from transvaginal mesh complications reported between 2005 and 2010.

In 2011, the FDA reported that 10 percent of women implanted with vaginal mesh devices experienced complications within one year of the surgery. Dr. Michael Carome, deputy director of the Public Citizen’s Health Research Group, has urged the FDA to issue a recall of transvaginal mesh devices, stating that the absence of clinically significant benefits and the overwhelming evidence of serious and common risks makes the use of vaginal mesh implants “not ethically justifiable.”

Hundreds of lawsuits against the major vaginal mesh manufacturers have been consolidated into MDLs in the U.S. District Court for the Southern District of West Virginia under Chief Judge Joseph R. Goodwin. The first bellwether trials in the vaginal mesh MDLs, are scheduled to begin on February 5, 2013.