Lawsuit Alleges Supracervical Hysterectomy Spread Uterine Cancer

A California woman has filed a product liability lawsuit against the makers of the Wolf Power Morcellator, alleging that use of the medical device during a laparoscopic supracervical hysterectomy to remove uterine fibroids caused the spread leiomyosarcoma cancer throughout her body.  

The complaint (PDF) was filed by Sarah Salem-Robinson, and her husband Alan, in U.S. District Court for the Northern District of California on May 13, naming Richard Wolf Medical Instruments Corporation as the defendant.

The case is one of a growing number of supracervical hysterectomy cancer lawsuits filed in recent months against makers of power morcellators, which are medical devices used during the minimally invasive procedures to allow doctors to cut the uterine fibroid into tiny pieces that can be removed through a small incision in the abdomen.

For some women undergoing these procedures, power morcellators may cause serious problems if they have an unsuspected sarcoma contained within the uterus, as the device could cause this undiagnosed cancer to be spread throughout the abdomen, pelvis and other remote areas of the body.

According to allegations raised in the lawsuit filed by Salem-Robinson, a Wolf Power Morcellator was used during her supracervical hysterectomy performed at the Kaiser Santa Clara Medical Center on May 18, 2012. Prior to the minimally invasive surgery, doctors did not know that one of the fibroid tumors in her uterus contained cancerous leiomyoscarcoma (LMS) cells, which were allegedly disseminated through her peritoneal cavity by the morcellator.

Following the hysterectomy, Salem-Robinson was diagnosed with metastatic cancer and she has since developed four small lesions on her lungs, which are suspected of being signs of LMS cancer. She is pursuing claims against Wolf for negligence, strict products liability, breach of warranty, and fraud. Her husband is suing the company for loss of services. The couple is seeking both punitive and compensatory damages.

Concerns Over Morcellation during Supracervical Hysterectomy

Laparoscopy-assisted supracervical hysterectomy (LASH) is a medical procedure often recommended for removal of uterine fibroids, providing a minimally invasive surgery that reduces recovery time and carries reduced risks of infection or other complications. However, the procedures require use of power morcellators to cut the uterus and fibroids into small pieces.

Last month, amid mounting reports of patients diagnosed with leiomyosarcoma and other uterina cancers disseminated during laparoscopic hyesterectomy procedures, the FDA issued a public safety communication that urged doctors to avoid using power morcellators for fibroid removal.

The FDA indicated that about one out of every 350 women who undergo laparoscopic hysterectomy or uterine fibroid removal has undiagnosed cancerous sarcoma cells, and there is no reliable way to detect the cancer before surgery. The federal regulatory agency indicated that use of power morcellators carries an unreasonable risk of spreading the cancer, reducing the likelihood for long-term survival, and encouraged doctors to consider traditional hysterectomy or myomectomy procedures where morcellation is not performed.

Following use of a power morcellator, the uterine cancer may be “upstaged” from stage 1 to stage 4, greatly reduces the long-term survival rates and decreases quality of life for the patient.

As women and families learn that cases of stage 4 LMS or other cancers diagnosed following a hysterectomy or myomectomy may have been caused by the use of morcellators, questions are being raised about why adequate warnings were not provided and whether Wolf and other manufacturers failed to make the devices as safe as they could have been.

Salem-Robinson alleges that Wolf Corporation failed to conduct adequate testing on the risk of power morcellators spreading uterine cancer, indicating that information was concealed from the FDA, National Institutes of Health and the general medical community about the risk that uterine morcellation may be harmful to humans.

Following the FDA warnings last month, Johnson & Johnson’s Ethicon subsidiary announced that it has halted sales of morcellators until it can determine if there is a safe way to use them for uterine fibroid removal.

FDA officials say they plan to hold a hearing this summer to determine next steps and to hopefully answer some questions as to why the medical community was not better informed.