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A recently filed product liability lawsuit alleges that a Gynecare Tissue Morcellator used during a robotic uterine fibroid removal and laparoscopic hysterectomy caused the spread of cancerous tissue throughout a South Carolina woman’s body, placing her at high risk for distant metastatic disease.
The complaint (PDF) was filed by Andrea Phillips and her husband, Kevin, in U.S. District Court in South Carolina on May 22, naming Johnson & Johnson and its Ethicon subsidiary as defendants.
Phillips indicates that she underwent a robotic myomectomy in May 2012, due to dysfunctional uterine bleeding. The minimally invasive procedure involved the use of a tissue morcellator to cut up and remove uterine fibroid tissue through a small incision in the abdomen.
In September 2013, she underwent a supracervical laparoscopic hysterectomy, also involving the use of a Gynecare Tissue Morcellator, after more fibroids were found.
Prior to the procedures, testing found no signs of disseminated or metastatic cancer. However, Phillips was later diagnosed as having either low grade leiomyosarcoma or low grade smooth muscle tumors of uncertain malignant potential.
“Had the Gynecare Power Morcellator used on Plaintiff not disseminated the aforesaid atypical, pre-cancerous and/or cancerous cells and tissue at the time of the aforesaid surgeries, Plaintiff would not have suffered and been diagnosed with a recurrence of her pelvic and abdominal tumors, an “upstaging” of her tumors and the potential for distant metastatic disease for which she is now at high risk,” according to the complaint.
Laparoscopic tissue morcellators are medical devices increasingly used in recent years to allow doctors to remove the uterus or uterine fibroids through a small incision, providing shorter recovery times and reduced risk of infection or other complications.
Over the past year, concerns have emerged over severe and potentially life threatening risks the devices may pose for women with occult or unsuspected sarcoma hidden within their uterus. For these women, tissue morcellation may spread the contained cancer cells, causing disseminated leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers.
In April 2014, the FDA announced that it was investigating the morcellation cancer risk, estimating that 1 out of every 350 women undergoing surgery for symptomatic uterine fibroids may have unsuspected sarcoma.
An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.
Phillips is one of a growing number of women who have filed a Gynecare morcellator cancer lawsuit after being diagnosed with leiomyosarcoma or the spread of other cancerous tissue. All of the complaints involve similar allegations that manufacturers of the devices failed to adequately warn the medical community and patients of the risk of disseminating cancerous cells.
Phillips is pursuing claims against Johnson & Johnson and Ethicon for negligence, designing a defective medical device, failure to warn, breach of warranty, fraudulent misrepresentation, and violating South Carolina trade practices. Her husband is charging the defendants with loss of consortium. The couple is seeking both punitive and compensatory damages.