In a new morcellator lawsuit, a woman from Texas says her cancer was aggravated due to a lack of adequate warning information about power morcellators.

Plaintiff Daun E. is suing medical device manufacturer Ethicon Inc., its parent company Johnson & Johnson, and their related companies.

Ethicon is the manufacturer of a power morcellator that she says spread cancerous tissue throughout her abdomen and caused the disease to upstage.

Daun says that in April 2009, she underwent laparoscopic supracervical hysterectomy. In the course of that procedure, her surgeon used a power morcellator made by Ethicon to dissect her uterus for removal.

Later, Daun says she was afflicted with parasitic uterine myomas that required further surgery. In May 2014, she says she underwent surgery to remove several smooth muscle neoplasms on her abdominal wall and peritoneum, identified as leiomyomas.

Daun now claims her leiomyomas were able to spread and advance because of the morcellation done during her 2009 surgery. She says that before that surgery she was not warned that morcellators could spread latent cancerous cells.

Morcellator Lawsuit Says Warnings Were Inadequate

According to Daun’s morcellator lawsuit, an estimated 650,000 women in the U.S. will undergo a surgical myomectomy or hysterectomy for treatment of uterine fibroids. Conventional surgery techniques allow the uterus or fibroids themselves to be removed intact.

In laparoscopic surgery like the procedure Daun underwent, the tissue to be removed generally needs to be cut into smaller pieces to fit through the smaller incisions used. A power morcellator does this by gripping the tissue and holding it against an assembly of spinning blades.

The problem with morcellation surgery is that if it’s conducted in the presence of cancerous tissue that went undetected prior to surgery, it can cause that tissue to spread elsewhere in the body.

Daun’s morcellation lawsuit says the procedure can leave fragments of morcellated tissue behind inside the body. The tissue may migrate farther away by way of the vascular or lymphatic systems, then lodge in other organs and continue to grow.

Daun argues her morcellator cancer resulted from defective design of the power morcellator used. She claims that Ethicon and J&J knew long before her 2009 surgery that these devices had the potential to upstage undetected cancer, according to her morcellator lawsuit.

As early as 1991, she says, a patent for a surgical tissue bag mentions that it could be effective for preventing the spread of malignant tissue to other parts of the body. Further scientific studies from 1997 through 2011 fleshed out some of the details of the problem, Daun says.

She also cites an FDA announcement from April 2014, indicating that the agency would begin looking into the matter. The agency followed up in November 2014 asking all morcellator manufacturers to add two contraindications and a boxed warning to their labeling, advising that morcellation surgery is inadvisable for most women patients.

Yet despite the publicly available information addressing the risk of morcellator cancer, Ethicon and J&J failed to respond with a proper warning about the risks, Duan argues. She says that any warning offered was not commensurate with the risks involved.

Daun’s morcellator lawsuit raises claims based on negligence, strict liability, and breach of warranty. She seeks an award of damages in excess of $75,000, plus costs and attorneys’ fees.

The Power Morcellator Lawsuit is Case No. 4:16-cv-899, in the U.S. District Court for the Southern District of Texas.