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Amid continuing debate within the FDA over the risk of laparoscopic morcellation spreading cancer, a group of doctors are suggesting that the devices should not be completely abandoned until more data is obtained, but stress the importance of providing patients with more information about the risk so that they can provide informed consent.
In a clinical opinion published online by the American Journal of Obstetrics & Gynecology (AJOG) on July 26, researchers from NorthShore University Health System and the Mayo Clinic indicate that there is not enough data to support the recent calls for a moratorium on power morcellation procedures during laparascopic hysterectomy or myomectomy.
While the researchers acknowledge there is a risk with the device, they suggested that doctors and hospitals thoroughly inform patients of what they know about links between power morcellation and cancer and decide for themselves. The opinion was published just days before the largest manufacturer issued a power morcellator recall, admitting the devices were too risky.
Power Morcellation Cancer Concerns
Power morcellators are medical devices used during a minimally invasive laparoscopic hysterectomy or uterine fibroid removal surgery, allowing the uterus or fibroids to be cut up and removed through a small incision in the abdomen.
More than 500,000 morcellation procedures have been performed annually in recent years, due to the benefits provided of reducing recovery time, minimizing scarring and the risk of infection. However, use of devices has largely stopped in recent months, following FDA warnings in April that indicated the laparoscopic power morcellation may cause the spread of cancerous tissue for women with unsuspected sarcoma.
FDA estimates have suggested that about one out of every 350 women who undergo uterine fibroid surgery have unsuspected sarcoma contained within the uterus, with about one out of every 400 women having the even deadlier leiomyosarcoma. These uterine cancer cells are hidden inside some fibroids, and there is no effective way for doctors to diagnose the cancer prior to a hysterectomy or removal of the uterine fibroids.
For these women with unsuspected sarcoma contained within the uterus, power morcellators have been known to spread cancerous tissue throughout the peritoneal cavity, quickly upstaging the cancer within a matter of days or weeks. This may greatly reduce long-term survival chances and greatly diminish the overall quality of life.
Earlier this month, a panel of FDA advisors were unable to decide whether to recommend a power morcellator ban and recall, or whether to place a black box label warning on the device. The agency is expected to make a final determination soon.
Informed Consent for Uterine Fibroid Morcellation
In this recent report, researchers indicate that there remains a lack of data across the board, which inhibits making a final decision on power morcellators. They also noted that there is no evidence that alternatives to laparoscopic hysterectomy with morcellation do not also spread cancer.
Until such evidence is collected, the researchers stress that doctors should not outright stop using power morcellation, but should instead engage patients in conversation and educate them as thoroughly as possible on the benefits of the minimally invasive procedure, like reduced scarring and faster recovery time, and the risk of cancer.
“Given the actual reduction of sarcoma spread has never been demonstrated in vivo for any alternative procedures to extract uterine tissue, placing a moratorium on power morcellators may be premature,” the researchers concluded. “We emphasize given the lack of high quality data, at the present time the focus should be on adequate informed consent.”
The clinical opinion mirrors those put out in May, by the American Congress of Obstetricians and Gynecologists, which runs and publishes AJOG. That organization said that a power morcellator moratorium was premature, and that it was impossible to conduct a surgical procedure without risk. The group also cast doubt on the FDA’s assessment of the level of risk to women.
However, their opinion was published just days before the leading manufacturer of the devices announced that they were exiting the power morcellator business due to the cancer risks, and that they would not make or sell the devices until safer technology could be developed.
On July 30, Johnson & Johnson’s Ethicon subsidiary determined that there is sufficient evidence of the potential cancer risk to recall their power morcellators from the market, urging hospitals to return the devices. Since Ethicon morcellators represent 72% of the market, the decision may lead other manufacturers to follow suit.
Morcellator Lawsuits Filed By Women With Cancer Spread
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 earlier and whether manufacturers failed to make the devices as safe as they could have been.
Johnson & Johnson’s Ethicon division and other manufacturers now face a growing number morcellation cancer lawsuits being pursued on behalf of women diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other cancers that were were allegedly spread during a laparoscopic hysterectomy or uterine fibroid removal surgery.
Lawsuits allege that women 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.