Jon Campisi Jun. 1, 2012, 10:36am

An Indiana woman who claims she sustained injuries as a result of having a pelvic mesh device surgically implanted in her body has filed a product liability complaint against the device’s manufacturer.

In her civil action, filed late last week at the federal court in Philadelphia, Sandra Shaughnessy claims that Chadds Ford, Pa.-based Endo Pharmaceuticals and Minnesota-based American Medical Systems failed to warn against the dangers of the transvaginal mesh products used to treat pelvic organ prolapse and stress urinary incontinence.

The lawsuit, filed May 25 by Florida attorney James D. Barger, of the firm Aylstock, Witkin, Kreis & Overholtz, claims that Shaughnessy has experienced mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity, and has had to undergo corrective surgery as a result of her having had the Subfascial Hammock mesh product implanted into her body during a surgery at an Indiana hospital.

Shaughnessy has also suffered financial loss and lost wages as a result of her injuries, the lawsuit alleges.

The lawsuit faults the defendants for failing to disclose the dangers of the monofilament polypropylene mesh when implanted into the body.

“Despite claims that this material is inert, the emerging scientific evidence suggests that this material is biologically incompatible with human tissue and promotes an immune response in a large subset of the population receiving Defendants’ Medical Device(s) containing this material,” the lawsuit states. “This immune response promotes degradation of the pelvic tissue and can contribute to the formation of severe adverse reactions to the mesh.”

The complaint states that contrary to the defendants’ marketing of the mesh products to the community and patients as safe, in reality, the medical devices have high failure and complication rates, and often fail to perform as intended.

“The Defendants have consistently underreported and withheld information about the propensity of its Medical Device(s) to fail and cause injury and complications, and has misrepresented the efficacy and safety of its products and, through various means and media, actively and intentionally been misleading the FDA, the medical community, patients, and the public at large,” the suit states.

The suit alleges that the defendants have failed to perform or rely on adequate testing and research in order to determine and evaluate the risks and benefits associated with the mesh devices.

The lawsuit contains counts of defective products, negligence, constructive fraud, negligent misrepresentation, negligent infliction of emotional distress, breach of express and implied warranties and unjust enrichment.

For each of the counts listed in the suit, the plaintiff seeks $75,000 in compensatory damages, in addition to attorney’s fees, travel expenses, witness expenses, litigation costs and other court relief.

A jury trial has been demanded.


The federal case number is 2:12-cv-02917-SD. 

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