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The dangers of defective medical devices

Patients in California trust in the health care community to offer safe and effective treatments, which sometimes come in the form of medical devices. However, one such device known as transvaginal mesh has been shown to cause serious injuries to women undergoing the procedure. At Callahan & Blaine we've seen firsthand the damage that can result from defective medical devices, from the need for further surgery to loss of life in severe cases.

Transvaginal mesh is intended to treat incontinence and pelvic prolapse in women. Because the design of this device is similar to mesh used in the treatment of abdominal hernias, the manufacturer was not obligated to submit to the comprehensive testing that would occur with new medical devices. As a result, many patients undergoing this treatment have experienced a range of significant side effects.

The U.S. Food and Drug Administration has collected numerous reports of injuries related to the implantation of transvaginal mesh. These include painful or difficult intercourse, problems with urination and scarring. In addition, transvaginal mesh may also erode into internal organs and subsequently cause perforation. Bouts of internal bleeding may occur as a result of this perforation, along with a greater risk of infection.

Upon review of these adverse event reports, the FDA alerted medical professionals of the risk of these medical devices. One recommendation involved looking for alternate treatments when at all possible, as research shows that transvaginal mesh offers no obvious benefits over other treatments. The FDA also urged doctors to properly inform patients of all applicable risks should they undergo this procedure.

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