Doctors Divided Over FDA Warning on Power Morcellators

Warning_on_Power_MorcellatorsIn April 2014, the Food and Drug Administration (FDA) issued a safety advisory to surgeons, asking them to stop using power morcellators during uterine surgery because of the risk of spreading cancerous tissue. In July, the agency convened a panel of outside experts to consider whether the device should be banned.

Many hospitals put moratoriums on use of the tool, some insurers stopped covering its use, and Johnson & Johnson, the device’s maker, has halted sales. But in spite of the warning, many doctors continue to us power morcellators, according to EmpowHer, a women’s health web site.

The power morcellator is used in fibroid tumor and hysterectomy surgery to enable the physician to perform minimally invasive surgery. With the morcellator, high speed blades cut tissue into small pieces that are removed through small incisions. Surgeons favor minimally invasive techniques, where possible, because surgeries performed through very small incisions involve less blood loss, smaller scars, and faster recovery times. But women with undetected cancers are at risk of having the cancer spread through the abdomen if a power morcellator is used, EmpowHer says. According to the FDA about 1 in 350 women undergoing these surgeries has undetected cancer, which, if spread by the morcellator, can lower the woman’s long-term survival chances.

The FDA has not yet announced its decision about a ban on power morcellators.  Physicians disagree about banning the device.  Dr. Robert Graebe, who chairs the Department of Obstetrics and Gynecology chairman at Monmouth Medical Center in New Jersey, had first thought the FDA was overreaching but now agrees with the safety advisory. He thinks the device should be shelved until proven safe, according to The Wall Street Journal. Other doctors believe the cancer risks are overblown and the FDA should not interfere with their treatment decisions. The American College of Obstetricians and Gynecologists argues that with stricter patient-selection guidelines, the device remains an important tool.

The FDA says women who have already had a procedure done with a power morcellator should follow up with the doctor, according to EmpowHer.



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