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Power Morcellator Lawsuits Increase while Lawmakers Question FDA

female patient in doctor's officeA woman who has experienced catastrophic side effects after power morcellation was used during her 2013 hysterectomy has received support from some federal lawmakers. At the time of her surgery, Dr. Amy Reed unknowingly had uterine cancer that was spread throughout her body by the morcellator. Although Reed chose not to file a power morcellator lawsuit after her injuries, she has waged a public campaign in an effort to stop the use of these devices in women’s surgeries.

Reed and her husband, Hooman Noorchashm, MD, PhD, both had thriving medical practices in Boston at the time. Reed worked as an anesthesiologist and Noorchashm is a cardiothoracic surgeon. Reed underwent her hysterectomy to remove uterine fibroids. The power morcellator was recommended as a way to break up the uterus and remove it through a smaller incision and a much less invasive procedure than a traditional hysterectomy.

Cancer detected after hysterectomy

Although the doctors caring for Reed assumed the fibroids were benign prior to her surgery, it turned out undetected cancer cells were also present in the uterus. The morcellator spread the cancer cells throughout the abdomen and pelvic area, making the cancer much more difficult to treat – and Reed’s prognosis much more serious. Although Reed, 41, had been in apparent remission for approximately one year after her surgery, in February 2015, a new tumor was detected on her spine. Reed underwent another surgical procedure to have the tumor removed and doctors believe they were able to remove all of the returning cancer.

The latest setback has not thwarted the couple’s resolve to get morcellators removed from the market entirely. Now, two congressmen, from their home state of Pennsylvania, have joined in their fight. Sen. Robert Casey Jr. (D-PA) and Rep. Michael Fitzpatrick (R-PA) have sent letters to the FDA, questioning their response to reports that power morcellators led to dire uterine cancer diagnoses. Both addressed their letters directly to Margaret Hamburg, the FDA commissioner at the time.

Letters sent to FDA, products pulled

In his February 19 letter, Fitzpatrick asked the commissioner why the FDA did not ban the use of morcellators outright. Casey’s letter asked additional questions, including when the FDA first learned of the safety concerns and what data the agency is collecting about adverse events involving power morcellators. Casey also wants to know if adverse events have been linked to any particular manufacturer of morcellators.

One of the manufacturers of these devices, Johnson & Johnson’s Ethicon division voluntarily took their morcellator devices off the market. The health insurance company Aetna has also announced it will end coverage for hysterectomies using power morcellators, unless the patient is a premenopausal woman wishing to maintain her fertility or a woman that is not a good candidate for the more invasive hysterectomy procedure. Noorchashm sent an email to the insurance company, thanking them for acting in the best interest of the general public.

While Reed and Noorchashm continue to fight their battle on the public front, other women are fighting their battles in court. The power morcellator lawsuit number continues to climb nationwide, as women seek damages for their injuries, medical bills and other non-economic losses. Individuals eligible for these lawsuits include women that have been injured by the devices and family members that have lost loved ones due to cancer that was spread by a morcellator.

  1. Medscape, Two Congressmen Turn Up Heat on Power Morcellators,
  2., Doctor Fighting to Ban Morcellators Has Cancer Recurrence,
  3., Aetna Curtails Coverage of Surgical Tool Tied to Cancer Risk,
  4. Medscape, Aetna won’t Pay for Most Fibroid Removal Using Morcellators,
  5. FDA, Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication,