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Responses to Use of Power Morcellators by the FDA, FBI, GOA and Market

Posted By Anapol Weiss on this February 3, 2016 at 11:30 am

The first reference to power morcellators spurring the ongoing controversy was in December 2013 when the Wall Street Journal profiled Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center in Boston. Dr. Reed underwent a routine morcellation laparoscopic hysterectomy at Brigham & Women’s Hospital to remove uterine fibroids and discovered – after the surgery – that the mass her surgeons had assumed was benign was in fact leiomyosarcoma.

Dr. Reed, who now lives in the greater Philadelphia region with her husband and six children, recently underwent surgery for a third recurrence of the disease. WSJ reporter Jennifer Levitz recognized in this article that the gynecological specialty worldwide was assuming that tumors of the uterus, known as fibroids or leiomyomas, are non-cancerous or benign.

FDA Warns against Power Morcellator Use during Laparoscopic Procedures

In April 2014, the FDA issued a safety communication advising against the use of power morcellators during laparoscopic procedures. After reviewing extensive medical literature, the FDA found that the risk of a woman undergoing a hysterectomy or myomectomy having an unsuspected sarcoma may be as high as 1 in 350 for all types of uterine sarcomas. Johnson & Johnson (J&J) responded by suspending world-wide sales and distribution of its power morcellators.

Both the FDA and J&J took greater steps in the months to follow. In July 2014, the FDA convened an advisory panel to discuss mounting concern with the use of power morcellators in gynecological surgeries. The FDA panel issued a directive discouraging doctors from using the device because of the risk of spreading undetected cancer. Days later, J&J called for a voluntary worldwide market withdrawal of the tool.

In November 2014, the FDA issued a black box warning – the highest level of caution – to help reduce the risk of spreading unsuspected uterine cancer in women being treated for uterine fibroids. The FDA recommended that manufacturers include warning that states in part: “The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.”

Since the FDA’s black box warning, other agencies have launched investigations into power morcellators and many physicians have recently spoken up as well.

Taking Action

Contact our firm if you underwent a minimally invasive hysterectomy or myomectomy and suspect your recurring health conditions may be related to the use of a power morcellator. Our attorneys are highly qualified to represent women and their families facing the devastation of upstaged cancer after morcellation.

Topics Unsafe Medical Devices