Transvaginal Mesh Material Not Intended for Permanent Use, Testimony Excluded

Boston, MAThe pendulum in the second bellwether trial in the transvaginal mesh lawsuit file has swung, again, toward the defendant. While pundits muse that this is not a good sign for TVT sling plaintiffs, the attorney representing plaintiff Maria Cardenas noted that the Court excluded what the plaintiff considered important testimony.

Might that testimony have swung the verdict in a different direction?

Transvaginal mesh has been used in recent years to treat conditions common to middle-age women having borne children: the sagging of internal organs, which can press upon the uterus. Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) are two conditions that are commonly treated with transvaginal mesh inserted laparoscopically through a small incision and deployed inside the abdomen by a surgeon guided by a small camera.

Such a TVT sling procedure has been favored in recent years over more traditional options such as invasive surgery to place TVT mesh or the use of a patient’s own tissue to shore up wayward organs. Healing time is reduced, freeing up hospital beds.

However, there have since been thousands of complaints with regard to transvaginal mesh complication. Cardenas claims she was injured by Obtryx transvaginal mesh manufactured by Boston Scientific. Transvaginal mesh has been known, in other patients, to migrate and become entangled with bowels and other organs, or protrude through the uterine wall, injuring both the woman and her sexual partner. Often, revision surgery is needed to alter the transvaginal mesh complication. However, such surgery is not possible in every case, leaving the woman to deal with a lifetime of chronic pain.

Cardenas’ legal team noted that an important exclusion might have led the jury to a different conclusion, had the testimony been allowed. To that end, the Court excluded testimony from the surgeon who implanted the TVT mesh into Cardenas’ abdomen. The surgeon had testified that he would not have employed the Obtryx product had he been aware of a warning on the data safety sheet related to the mesh material that stated the material was not intended for permanent implantation in the human body.

Had juries in this and a previous trial been allowed to consider such testimony in their deliberations, might they have come to a different conclusion? The jury in the Cardenas case found that the Obtryx transvaginal sling manufactured by Boston Scientific was not defective, and the company quite properly and adequately warned about the device.

Given the exclusion of the expert testimony by Cardenas’ surgeon, it provides certain grounds for an appeal of the transvaginal mesh lawsuit verdict. The case is Maria Cardenas v. Boston Scientific Corp., Case No. MICV2012-02912, in the Superior Court of the Commonwealth of Massachusetts, County of Middlesex.