Power morcellators are medical devices used during various laparoscopic surgeries, such as hysterectomies and myomectomies, that aggressively cut uterine tissue into small pieces. This permits the tissue to be removed through a small incision site, with the proposed benefits including shorter recovery periods, fewer complications, and less pain.
However, due to recent scrutiny and a rise in reports in the medical literature, the FDA issued a safety alert in April 2014 discouraging the use of these devices in uterine and fibroid removal procedures, as they may spread an undetected or unsuspected uterine sarcoma. In this safety alert the FDA also noted there is no reliable method for accurately detecting uterine sarcoma prior to hysterectomy or myomectomy. In addition, according to the FDA, an estimated 1 in 350 women who undergo these procedures may have undiagnosed uterine cancer.
In response to this FDA communication, Johnson & Johnson’s power morcellator manufacturing unit, Ethicon, suspended all worldwide sales and distribution of power morcellators and ordered a voluntary market withdrawal, affecting all Johnson & Johnson morcellator products, including its Gynecare Morcellex, Gynecare X-Tract, and Morcellex Sigma. Several hospitals have suspended use of these devices. At least one insurance carrier will no longer cover procedures involving power morcellation.1
The inherent risk of power morcellation is the dissemination of the broken-up tissue. Benign tissue can become implanted on abdominal structures and organs, resulting in conditions such as fibroids, endometriosis, and adenomyosis, potentially requiring further surgery. Furthermore, power morcellators can spread malignant tissue from an undiagnosed uterine cancer, including leiomyosarcoma, endometrial stromal sarcoma, carcinosarcoma, and endometrial adenocarcinoma, and significantly worsen a patient’s prognosis from treatable to deadly.
According to The Pittsburgh Business Times, Johnson & Johnson may have been aware of the serious risks associated with power morcellators well in advance of the FDA’s warning.2 In 2006, eight years before their suspension of sales, Dr. Robert Lamparter, 63, then pathologist at Evangelical Community Hospital in Lewisburg, Pennsylvania, wrote to the company imploring them to “reconsider the risk [of power morcellators] to the patient” as these devices “may lead to dissemination of malignant tissue” during the removal of the uterus or uterine fibroids, as prescreening for cancer before the procedure is not always effective.
As Lamparter pointed out in his complaint, “When the operative procedure is a standard hysterectomy, no damage is done. If a morcellation is done, the patient’s survival is jeopardized.”
The email correspondence between Lamparter and Dr. David Robinson, then medical director of Ethicon Women’s Health and Urology division, indicates that the Johnson & Johnson subsidiary company responded only by including a precaution in the labeling for their morcellators’ instructions for use, but neglected to act further at the time.
Lori Pasternack of Ethicon’s World Wide Customer Quality department dismissed Lamparter’s complaint in a May 10, 2006 letter. Lamparter appealed them to reconsider, saying the morcellator’s “potential to inadvertently do harm” was too great of a risk to ignore. It was not until after the FDA’s issued warning in April 2014 that Johnson & Johnson suspended the marketing and distribution of their power morcellators.
Plaintiffs in power morcellator lawsuits may be eligible to receive compensation for a variety of reasons including medical costs, lifestyle stress, wrongful death, and pain and suffering. For example, patients who develop advanced stage, metastatic cancer or parasitic fibroids after undergoing power morcellation may be able to recoup medical expenses, from doctor visits and diagnostic procedures to the cost of surgery and chemotherapy. The physical and mental pain and suffering associated with necessary subsequent treatments and a worsened prognosis will have a significant impact on a patient’s quality of life and is further cause for compensation. As a deterrent to future negligence, women may also be entitled to punitive damages as a result of the failure of device manufacturers to properly and thoroughly warn about the risks of the procedures.
In March 2014, a widowed husband filed a hysterectomy cancer lawsuit in the U.S. District Court, Eastern District of Pennsylvania, after his 53-year-old wife died from uterine cancer less than a year after undergoing hysterectomy that used power morcellation to treat uterine bleeding in March 2012.3 While the precise manufacturer has yet to be identified, the complaint names Blue Endo, Ethicon, and LiNA Medical, among others, as defendants. Another case has been filed in the U.S. District Court for the District of New York by a woman who was diagnosed with cancer after having robot-assisted hysterectomy that used power morcellation.
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