Following Power Morcellator Lawsuit FDA Convenes Panel To Review Device

October 05, 2015 – – Tracey & Fox has commented on the panel convened by the U.S. Food and Drug Administration to review the risks associated with the use of a power morcellator.

A few months prior, the FDA had released a safety warning indicating that they had determined that there was a possible serious risk associated with the morcellator. The warning stated that if the power morcellator was used during a gynecological surgery, and the patient had undetected uterine cancer, the device might spread the cancer to other areas of the body. From July 10th – 11th, the FDA’s Obstetrics and Gynecology Devices Panel met to “seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data.”

The panel findings were ultimately inconclusive, although the panel suggested that surgeons use every available resource to diagnose uterine cancer prior to surgery.

Many were outraged by the FDA’s failure to ban the use of the power morcellator, including Dr. Amy Reed who has been speaking out against the morcellator since 2013. Dr. Reed alleges that her own uterine cancer was spread and upstaged by the power morcellator and, as a result, she has had to undergo extensive chemotherapy and radiation treatments. In her shock after the panel’s announcement, she suggested that the gynecologists on the panel should be held criminally liable for defending the morcellator.

Since the public has been made aware of the dangers of the morcellator nearly 30 lawsuits have been filed against multiple manufacturing companies. Each case alleges that the use of a morcellator during a hysterectomy or myomectomy spread undiagnosed uterine cancer. Each plaintiff has had to undergo chemotherapy treatments and, in some cases, the plaintiff has passed away leaving loved ones behind.

Following the panel’s decision, Johnson & Johnson announced that they were voluntarily withdrawing all of their morcellators from the market, and sent a letter urging doctors around the globe to return the device. At this time, none of the other manufacturers have withdrawn their products.

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Contact Tracey & Fox:

Sean Tracey
713-495-2333
440 Louisiana Street , Suite 1901
Houston, TX 77002

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