Major Hospital Chain Bans Uterine Morcellation Due to Cancer Risks
Amid concerns about the risk of leiomyosarcoma and other cancers being spread by uterine morcellation, a company representing more than 280 hospitals and surgical centers throughout the U.S. and U.K. has banned use of the controversial devices during minimally invasive surgery.
Last week, the Hospital Corporation of America (HCA) Holdings, Inc. announced that it will not allow doctors to use power morcellators for uterine fibroid removal or hysterectomy surgery, indicating that there is too great a risk of accidentally spread undiagnosed cancerous cells throughout a woman’s uterus, leading to advanced stage cancer.
The decision came after the FDA announced on November 24 that it is adding a black box warning to uterine morcellators due to their links to increased cancer risk. The warning is the strongest that the agency can require. However, many critics say the FDA should have recalled the devices.
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Instead of issuing a power morcellator recall, the FDA put in place label warnings and contraindications that make power morcellators almost useless if they are followed.
In addition to the new warning, the FDA indicated that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision. The contraindication essentially prohibits the use of the devices in the vast majority of women who undergo laparoscopic uterine morcellation procedures.
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.
Uterine Morcellator Cancer Risks
Concerns over uterine morcellation first began to surface about a year ago, when a Boston doctor, Dr. Amy Reed, was diagnosed with advanced stage leiomyosarcoma following a laparoscopic hysterectomy where a power morcellator was used. 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 suggests that about 1 in 350 women undergoing uterine fibroid removal actually have undiagnosed cancer cells in the fibroids. 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 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.
Since then, numerous hospitals and doctors have stopped using power morcellators, and some insurance companies have stopped covering their use. However, HCA Holdings is the largest group of hospitals to ban the devices so far.
Uterine Morcellator Cancer Lawsuits
As women and families learn that cases of aggressive uterine cancers diagnosed following a laparoscopic hysterectomy or uterine fibroid surgery 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 morcellation cancer lawsuits are now being pursued on behalf of individuals diagnosed with the spread of cancer following surgery.
Plaintiffs allege that power morcellators are unreasonably dangerous, indicating that they may have avoided the rapid spread of cancer throughout their body if information about the risk had been provided to the medical community.
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.
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