A couple from Pennsylvania has filed a morcellation cancer lawsuit against manufacturer Ethicon and its parent company Johnson & Johnson, alleging one of the morcellator caused cancer to spread.

Plaintiff Jennifer S. explains in the morcellation cancer lawsuit, filed with her husband Randall S., that she underwent a total laparoscopic hysterectomy in December 2012 for the removal of uterine fibroids. In the course of the surgery, the surgeon used a Gynecare Tissue Morcellator manufactured by the defendants. Prior to surgery, she showed no evidence of cancer, but in January 2014 a visit to the emergency room revealed a pelvic mass.

The mass was surgically resected, and she was diagnosed with metastatic serous carcinoma. She subsequently underwent six rounds of chemotherapy.

Jennifer alleges in her morcellation cancer lawsuit that prior to the surgery, she received no warning as to the risks of spreading unknown, or occult, cancer cells during the use of the power morcellator. She alleges that the power morcellator disseminated her occult cancerous tissue, causing the later malignancy.

Power Morcellators and Uterine Surgery

A power morcellator is a surgical instrument used to cut a larger mass of tissue into smaller pieces that can be more easily removed from the body. Morcellation is useful in laparoscopic surgery, where the small incisions might not permit removal of larger masses of tissue.

For a hysterectomy or removal of uterine fibroids (known as myomectomy), laparoscopic surgery can be preferable to traditional surgery because it generally requires a shorter postoperative recovery time and less risk of infection.

In April 2014, the FDA issued a safety communication warning that power morcellation during gynecological laparoscopic surgery may inadvertently spread unsuspected cancerous tissue, particularly uterine sarcoma and leiomyosarcoma, beyond the uterus. Once that type of cancer spreads, the survival rate is poor. The FDA estimates about one-in-350 women who undergo a hysterectomy or a myomectomy has an unsuspected uterine sarcoma.

Based on that risk, the FDA now discourages the use of power morcellators for extraction of the uterus or uterine fibroids. The federal agency notes the existence of many alternatives to power morcellation, including traditional vaginal or abdominal surgery, laparoscopic surgery without morcellation, laparotomy with a smaller incision, deliberate blocking of the uterine artery, ultrasound, and drug therapy.

However, some of these alternatives come with longer recovery time and slightly more pain than laparoscopic morcellation. The FDA plans to add a boxed warning to the device’s labeling.

In response to the FDA warning, manufacturer Johnson & Johnson withdrew its power morcellators from the market in August 2014. Other manufacturers continue to make their own versions of the device.

HCA Holdings, the parent company of hundreds of hospitals in the United States and England, has banned the use of power morcellators in its hospitals. Other healthcare organizations have imposed similar moratoria on power morcellators. Some surgeons continue to perform the procedure in younger patients, using special bags designed to contain the tissue and prevent the spread of cancerous cells.

Morcellation Cancer Lawsuits

So far Johnson & Johnson has faced only a few morcellation cancer lawsuits over its power morcellators. One morcellation cancer attorney estimates the company will face as many as 5,000 such power morcellator lawsuits.

Jennifer and her husband Randall allege the power morcellator used in her laparoscopic surgery was defective in design. They assert the defendants knew or should have known of the risk of spreading cancerous tissue during morcellation but did not properly address that risk. They claim the defendants failed to properly warn her or her doctor about the risks associated with morcellation.

The Morcellation Cancer Lawsuit is Case no. 1:15-cv-00782-SHR, in the U.S. District Court for the Eastern District of Pennsylvania.