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In a case of poor timing, a scientific paper was published saying there was not enough information to make an informed decision about recalling power morcellators about the same time the leading manufacturer of the devices recalled them over safety concerns.
Power morcellators are tools used in laparoscopic surgeries. Laparoscopic surgeries are a type of surgery in which the bulk of the operation happens inside the patient’s body. Small, specialized tools allow surgeons to operate within the body through tiny incisions, reducing recovery time. However, some surgeries, like hysterectomies, require surgeons to remove tissue or organs from the body. Morcellation is the technical term for cutting this tissue into smaller pieces for removal during laparoscopic surgery. However, concerns have been raised about the safety of this procedure, specifically morcellation cancer concerns.
It is suspected by the U.S. Food and Drug Administration (FDA) and medical researchers that laparoscopic morcellators can “liberate” cancer cells embedded in uterine tissue, allowing them to more easily and quickly spread through the body. The FDA has issued statements indicating that under certain circumstances, this could happen, but internal debate has prevented the FDA from issuing a more definitive statement, pending more information.
A study was published in the American Journal of Obstetrics & Gynecology (AJOG) in which the authors reached a similar conclusion to the FDA. They agreed that the data was unclear as to whether there was sufficient evidence that the benefits of power morcellators outweighed the risks.
Still, Johnson & Johnson, the leading producer of power morcellators, has decided to recall its devices. Johnson & Johnson’s Ethicon unit made the announcement on July 31, days after the AJOG article was published. Johnson & Johnson felt that enough evidence had mounted that power morcellators were dangerous, and made the decision to take its own off the market.
The authors of the study did strongly stress the idea of informed consent, that physicians should carefully explain the risks and benefits of power morcellators so that patients could make informed decisions regarding the devices.
Lawsuits have been filed by patients diagnosed with cancer after having hysterectomies and other laparoscopic surgeries with power morcellators. These lawsuits allege that the makers of power morcellators were aware — or reasonably should have been aware — of the serious risk associated with these devices.
In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.
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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.
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