Uterine Cancer Rates Among Women Undergoing Morcellation May Be 1 in 370
A new study suggests that about 27 women out of every 10,000 — or one in about 370 — who undergo morcellation to remove uterine fibroids has undiagnosed cancer, which could be spread throughout the body during the procedure, upstaging it to a very dangerous state.
In a letter published in the Journal of the American Medical Association (JAMA) on September 24, researchers from Columbia University present the findings of a study that appears to back up recent concerns about the link between the spread of cancer and morcellation during hysterectomy and myomectomy procedures.
Power morcellators are surgical tools that have become increasingly popular in recent years, allowing doctors to perform uterine fibroid surgery through a minimally invasive procedure.
During a laparoscopic hysterectomy or myomectomy, power morcellators may be used to cut up the uterus or uterine fibroids, allowing doctors to remove the tissue through a small incision in the abdomen.
The device was designed to reduce the recovery time and scarring, providing a generally safer procedure to a traditional hysterectomy or uterine fibroid removal. However, for women with undiagnosed cancer contained within their uterus, power morcellation may cause the spread of cancerous tissue throughout the body.
Hysterecomy Morcellation and Uterine Cancer
In April, the FDA issued warnings urging doctors to stop using power morcellators due to the cancer risks, since there is no reliable way for doctors to detect which women may have unsuspected sarcoma.
The agency estimated that about one out of every 350 women undergoing surgery with morcellation may have the undiagnosed uterine cancer, and the findings of this latest research appears to back up those findings.
Following a review of data from a large insurance database, researchers found that about 27 women out of every 10,000 who undergoes hesterectomy with morcellation were later diagnosed with uterine sarcoma. This translates to about one woman out of every 370, and does not include a number of other malignancies researchers discovered.
The findings reinforce concerns that have led a number of hospitals nationwide to announce that they will no longer use power morcellators during uterine fibroid removal surgery and for some health insurance carriers to stop covering the procedures.
Johnson & Johnson’s Ethicon unit, which previously controlled more than 70% of the market, has also announced a power morcellator recall this summer, determining that the devices were too great a cancer risk and that there was currently no way to make them safe.
An FDA advisory committee met this summer to evaluate the data and determined that there is no way to make power morcellators safe.
Despite the mounting evidence that a large number of women may be exposed to an unnecessary risk of spreading cancer from morcellation, recent reports suggest that some gynecologists are resisting giving up using the devices.
In a report by the Wall Street Journal last week, some doctors admitted to telling patients that the FDA and other researchers are wrong, when questioned by patients about the procedure, despite a lack of scientific studies supporting the safety.
Hysterectomy 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 and whether manufacturers failed to make the devices as safe as they could have been.
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.
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