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In a move almost certain to infuriate some activists and consumer watchdog groups, the FDA has decided not to recall hysterectomy morcellators that may spread cancer, instead allowing the controversial tools used during laparoscopic uterine fibroid surgery to remain on the market with “black box” warning.
The FDA announced the laparoscopic hysterectomy morcellator warning update (PDF) on November 24, and provided new recommendations regarding the use of device.
Power morcellators are tools that allow a surgeon to remove the uterus or uterine fibroids through a minimally invasive procedure, where the tissue is ground up and extracted through a small incision in the abdomen.
The new warnings come after months of evaluating the devices and the risk that power morcellators may spread cancer cells during a laparoscopic hysterecomy.
For women with unsuspected sarcoma prior to the uterine fibroid surgery, power morcellators can cause the cancerous cells to be spread throughout the body, rapidly advancing the stage of the uterine sarcoma or leiomyosarcoma, shortening life expectancy.
Over the past year, the FDA has faced growing pressure to recall the devices from lawmakers, consumer advocates and families of women diagnosed with advanced stage leiomyosarcoma, endometrial stromal sarcoma or other uterine cancer follow a laparoscopic hysterectomy where morcellation was performed.
While acknowledging that there is no current way to avoid the risk of power morcellators spreading undetectable cancer, the FDA has opted to keep the devices available and require manufacturers to provider stronger warnings that will be surrounded by a prominent black box.
Critics have said that such a warning will go unseen by most women undergoing the procedures, and the FDA has asked doctors to explain power morcellator cancer risks to their patients instead.
The FDA notes that it reserves the right to take more stringent action in the future.
“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health said in a press release. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”
The FDA has also issued a guidance on power morcellator label warnings (PDF) and updated its April safety communication.
In addition to the black box warning, the FDA has also contraindicated laparoscopic power morcellators in gynecologic surgeries where the tissue is known or suspected to contain malignancy and in patients who are peri- or post-menopausal or candidates for en bloc tissue removal through the vagina or via a mini-laparotomy incision.
While the contraindications are expansive, activists wanted the FDA to completely remove the devices from the market.
Power Morcellator Cancer Concerns
Concerns over power morcellators first began to surface about a year ago after a Boston doctor, Dr. Amy Reed, was diagnosed with advanced stage leiomyosarcoma following power morcellation. Her husband, Dr. Hooman Noorchashm, also a doctor, began a petition to have the devices removed from the market.
In April, the FDA announced that its own review indicated that 1 in 350 women undergoing uterine fibroid removal actually had undiagnosed cancer cells in the fibroids. The power morcellators grind those fibroids up, potentially spreading cancerous tissue throughout the woman’s body cavity. Since there is no way to detect the cancer cells before the procedure, the FDA urged doctors to avoid using power morcellators for uterine fibroid removal.
This summer, an FDA advisor panel met to review the available data and determined there was no safe way to use power morcellators. However, the panel of outside experts could not decide on whether to recommend the devices be recalled or whether a black box warning should be added.
Following the meeting, Johnson & Johnson’s Ethicon subsidiary, which manufactured about 70% of the power morcellator on the market at that time, announced a power morcellator recall for their devices and indicated that it will no longer be manufacturing the devices. However, other manufacturers have opposed calls for to recall their morcellators.
Earlier this month Dr. Noorchashm wrote an email to the FDA, saying he had heard the agency intended to allow power morcellators to remain on the market, and criticized the decision, saying that the FDA’s plan amounted to a sacrifice of women in order to kow-tow to the gynecological industry and to protect its medical device approval process.
Uterine Fibroid Morcellator Cancer Lawsuits
As women and families learn that cases of aggressive uterine cancers diagnosed following a laparoscopic hysterectomy or myomectomy may have been caused by morcellation, questions are being raised about why adequate warnings were not provided by the manufacturers of the devices.
A number of uterine cancer morcellation lawsuits are now being pursued on behalf of individuals diagnosed with the spread of cancer following a hysterectomy or myomectomy performed laparoscopically or through robotic surgery.
Plaintiffs allege that as they were originally designed and sold, power morcellators are unreasonably dangerous. In addition, women claim that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the medical community, since a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hyesterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.