FDA Issues Statement Discouraging the Use of Power Morcellators

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Recently, the FDA has warned doctors that the use of Power Morcellators in uterine surgeries may spread cancerous tissue within the abdomen and pelvis and may cause damage to other organs and compromise the long-term survival of patients with undetected uterine sarcomas. Pulvers, Pulvers, Thompson & Friedman explains why.

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Recent evidence suggests that the use of power morcellators may disseminate cancerous tissue within the body

What is a Power Morcellator?

The power morcellator is a device that is used to facilitate the removal of tissue by breaking it up, actually cutting it up into smaller pieces, so that can be more easily removed. The devices are used primarily in minimally invasive laparoscopic surgeries and have been extensively used to in performing hysterectomy (removal of the uterus) and myomectomy removal of fibroid tumors). The ability to perform such surgeries laparoscopically means a faster recovery time for patients with less risk of infection. Obese patients are especially at risk for complications when traditional surgical techniques are used. Laparoscopic surgery has been seen as a safer and less invasive alternative.

What are the dangers?

Recent evidence suggests that the use of power morcellators may disseminate cancerous tissue within the body. The FDA reviewed 18 studies of patients who underwent hysterectomy and myomectomy (removal of fibroids) between 1980 and 2011. According to the FDA:

"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 likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids."

What is being done?

The FDA is discouraging the use of power morcellators during hysterectomy and myomectomy and recommending that the risks be thoroughly considered and discussed with patients prior to surgery. A meeting in July of experts at the FDA did not result in a clear ban of the devices however there has been an increase in Power Morcellator Lawsuits.

Despite the fact that the FDA has not issued an official ban on power morcellators, many hospitals and surgeons discontinued their use based on these reports and recommendations. Additionally, Johnson & Johnson, the largest manufacturer of these devices, has voluntarily halted sales of power morcellators according to the Washington Post on July 30, 2014.

Meanwhile, some surgeons are suggesting that the use of a bag to collect tissue that has been morcellated will minimize the risk of it being disseminated into the abdominal cavity, according to the American College of Obstetricians and Gynecologists May, 2014 special report. More thorough screening of patients to detect uterine sarcomas is also recommended. It is estimated that 1 in 352 women may have undetected uterine sarcomas. These women are at risk if they undergo laparoscopic removal of fibroids or hysterectomy.

Patients who are surgical candidates for hysterectomy or myomectomy, should discuss these risks with their doctor and explore their surgical options.

For more information about laparoscopic hysterectomy or myomectomy with power morcellation, and the remedies available through the legal system, contact the New York personal injury attorneys at Pulvers, Pulvers, Thompson & Friedman today.

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Harlan Thompson

Harlan Thompson
Pulvers Pulvers & Thompson LLP
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