A panel of U.S. Food and Drug Administration experts, who met earlier this month near Washington, will report their findings in regard to the safety of laparoscopic power morcellation. The procedure, according to the FDA, can be used in “hysterectomy or myomectomy in women with uterine fibroids.”
The FDA announced in April that it has been monitoring adverse event reports submitted to the agency and other data in regard to the procedure. “Morcellation,” the FDA wrote in its April 17 safety communication, “refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.”
Based on what it knows so far, the FDA wrote the following on April 17. This is from the FDA, not from us: “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.”
The FDA convened July 10-11 a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to discuss the clinical role of laparoscopic power morcellation, whether there are accessories that can enhance safety, and whether some sort of warning related to the risks should be required.
In the executive summary of the FDA’s report to the committee, the agency wrote, “FDA believes that, in keeping with its public health mission, it is appropriate to have an open and transparent dialogue among FDA, manufacturers, health care providers, researchers, patients, and the public to review and discuss available data regarding the benefits and risks associated with the use of LPMs during gynecologic surgeries and generate scientifically-based recommendations on how to best communicate and, if possible, mitigate those risks.”
The product liability attorneys at Reich & Binstock will stay on top of these developments. If women have been harmed by the laparoscopic power morcellation procedure, they can find a capable and well-informed ally in the experienced attorneys at Reich & Binstock. The law firm operates in every state and may be reached either toll-free at the number below or through an electronic message submitted through its website.