Power Morcellator Lawsuit Update: Number of Lawsuits Grow

September 01, 2015 – – Tracey & Fox have reported continuous updates on where current power morcellator litigation stands. The number of lawsuits filed alleging that the use of a power morcellator spread undetected uterine cancer is growing at a steady pace.

Power morcellators have been used in gynecological laparoscopic surgeries for several decades, but it wasn’t until recently that the dangers associated with this surgical tool have been made known to the public. The tool was first approved by the U.S. Food and Drug Administration under a 501(k), which allows approval of a surgical instrument if it can be shown that the device is “substantially equivalent” to a previously approved device. Under the 501(k), the device seeking approval does not need to undergo safety testing.

Many women who undergo gynecological surgeries do so because of the presence of uterine fibroids. Most uterine fibroids are found to be benign, however, recent studies have found that around 1 in 350 women undergoing a hysterectomy or myomectomy have undetected uterine cancer. The form most commonly diagnosed is leiomyosarcoma, a form of cancer which is difficult to treat with chemotherapy and radiation. If a morcellator is used in women harboring undetected uterine cancer, the tool might disseminate the cancer cells to other areas of the abdomen, resulting in metastasis.

Following the first morcellator lawsuit which was filed on March 14th, 2014, the FDA released a safety warning on April 17th, 2014. The warning stated that “the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.” It further recommended that surgeons discuss the risks of using the morcellator with their patients prior to surgery.

The FDA then updated its warning on November 24th, 2014, stating that “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.”

The FDA has yet to issue a power morcellator recall, however, one of the largest manufacturers, Ethicon, issued its own worldwide voluntary market withdrawal on July 30th, 2014. Ethicon urged surgeons to return three of the morcellators, the Gynecare Morcellex, Morcellex Sigma, and Gynecare X-Tract immediately. To date, Ethicon is the only company which has voluntarily removed their surgical instruments from the market.

For more information regarding this press release, call Tracey & Fox at (713) 322-5375.

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Contact Tracey & Fox:

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

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