A new morcellator lawsuit filed by a husband and wife from Tennessee says a power morcellator made by LiNA Medical caused the wife’s cancer to spread and progress.

Plaintiffs Dawn and Gary P. are suing LiNA Medical USA Inc. and its associated companies, who they say are responsible for the design, manufacture and sale of the LiNA Xcise laparoscopic morcellator.

Dawn and Gary say that in April 2015, Dawn underwent a laparoscopic-assisted supracervical hysterectomy with uterine morcellation, using an Xcise morcellator in the process.

She says that during the surgery, the morcellator cut up and spread fragments of undiagnosed cancerous tissue elsewhere in her abdomen, aggravating her cancer and worsening her long-term prognosis.

Due to the nature of her cancer, she says, she will now have to undergo a long course of treatment and imaging studies. She says that upon learning that a power morcellator was used during her surgery, her oncologist immediately scheduled her for a trachelectomy, or surgical removal of the cervix, with a pelvic lymphadenectomy.

Morcellator Lawsuit Alleges Excessive Risk of Uterine Cancer

According to this morcellator lawsuit, LiNA designed the Xcise morcellator to be used for removing tissue during laparoscopic gynecological surgery. To remove large masses of tissue without using a larger abdominal incision, the Xcise pulls the tissue against a spinning blade that cuts it into pieces about 1 centimeter in diameter.

The plaintiffs allege that in the presence of cancerous tissue, the Xcise leaves behind microscopic tumor fragments, spreading cancerous tissue throughout the peritoneum – a phenomenon the plaintiffs describe as a “forced metastasis.”

The morcellator lawsuit cites a safety communication issued by the FDA in April 2014 that addressed the risk of upstaging cancer of the uterus via morcellation.

The FDA said that laparoscopic morcellation performed in women with unsuspected uterine cancer could cause the cancer to spread and could significantly worsen the patient’s chances of survival.

In the communication, the FDA estimated that 1 in 350 women undergoing hysterectomy or myomectomy for fibroid removal also has unsuspected uterine cancer. The agency also noted there is no reliable method for predicting whether a woman with fibroids may also have cancer of the uterus.

Dawn and Gary say the FDA updated its warning in November 2014, saying that in general, laparoscopic power morcellators should not be used in the majority of women undergoing fibroid surgery.

The plaintiffs now argue that LiNA knew about the risk of upstaging cancer of the uterus associated with power morcellation long before Dawn underwent surgery. They say the company was on notice due to the availability of multiple published reports and studies, as well as the FDA’s warnings.

Despite the availability of this information, the plaintiffs say LiNA failed to adequately warn patients or their doctors about the risks of power morcellation. They note that other, safer surgical alternatives exist that could treat uterine fibroids without the same risk of spreading cancer.

Dawn and Gary are seeking an award of compensatory damages in the specific amount of $6,525,000 and punitive damages totaling $2,525,000.

The LiNA Medical Morcellator Lawsuit is Case No. 2:2016-cv-00098, in the U.S. District Court for the Eastern District of Tennessee.