A power morcellator is a laparoscopic surgical instrument that is used to remove large tissue masses by inserting the morcellator into the body through small incisions. The morcellator is then used to mince up the targeted tissue, which is then vacuumed out through the same incision. This laparoscopic surgery process is designed to reduce the recovery time compared to traditional methods.
Unfortunately, if undetected cancer cells are present, the cells are then spread through the pelvic and abdominal area. In other words, the power morcellators can be the instrument that facilitates the spread of cancer in the patient’s body.
In April 2014, the FDA issued a safety communication warning against the use of power morcellators for hysterectomy and myomectomy patients with uterine fibroids. The warning also included the statement, “Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.”
In response to the FDA warning in April 2014, Johnson & Johnson’s Ethicon Division suspended the sale and marketing of the power morcellator worldwide. The manufacturer followed this with a letter in July of 2014 urging the discontinuation of the use of the morcellators and asking they be returned to the company immediately. The company recalled three types of morcellators, the Gynecare Morcellex, the Gynecare X-Tract, and the Morcellex Sigma. Johnson & Johnson is not the only manufacturer of power morcellator devices.
In July 2014, the FDA’s Obstetrics and Gynecological Devices Panel of the Medical Devices Advisory Committee met to consider statistics regarding the power morcellator. Data collected indicates that the spread of cancerous cells and intensification of the disease occurs in 25 – 64% of individuals who had undetected cancer. The FDA reported that 1 in 350 women may be at risk for the spread of cancer after procedures using the power morcellator. These patients are believed to have a decreased chance of survival compared to those that have undergone surgeries in which a power morcellator was not used.
In November 2014, the FDA mandated an even stronger warning that “the use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
Lawsuits include claims of negligence, fraudulent misrepresentation, failure to warn, failure to test properly, consumer risk, and failure to recall.
On July 2, 2015, it was announced that the first lawsuit filed against a manufacturer of laparoscopic power morcellators, device maker Lina Medical ApS, had been settled for an undisclosed amount. The case involved a Pennsylvania man whose wife, Donna, died in February 2013. The 53-year-old had a morcellator-aided hysterectomy 11 months earlier for heavy bleeding. She learned, nearly a week after her surgery, that she had a hidden cancer called leiomyosarcoma. Donna had no prior evidence or history of the cancer before the procedure.
Many of the patients injured by this device were not warned about the risks prior to undergoing surgery.
The current makers and models of power morcellators are:
- Blue Endo – MOREsolution
- Cook Urological, Inc. – Cook Tissue Morcellator
- Ethicon, Inc. – Gynecare Morcellex; Morcellex Sigma; Gynecare X Tract (Johnson & Johnson division that recalled all of its devices)
- Ethicon of FemRx – Diva
- LiNA Medical – Xcise
- Lumenis, Ltd. – VersaCut+ Tissue Morcellator
- KSE America – KSE Steiner Electromechanic Morcellator
- Karl Storz GmbH & Co. – ROTOCUT G1, G2; Swalhe II SuperCut Morcellator
- Olympus – PKS PlasmaSORD; VarioCarve Morcellator
- Richard Wolf GmbH – Morce Power Plus
If you or a loved one has suffered an injury from the use of a power morcellator during laparoscopic surgery, the attorneys associated with Jacoby & Meyers can help you receive compensation for your damages. Our lawyers can review the facts of your case to determine whether you have a valid claim.
Please contact the Jacoby & Meyers defective products attorneys today to schedule your free initial consultation.