FDA Failure to Ban Morcellators Amid Cancer Risk Draws Sharp Criticism
The Massachusetts couple who has led the movement to ban power morcellators, after the wife was diagnosed with the spread of leiomyosarcoma following a laparoscopic hysterectomy, is blasting the FDA for allegedly planning to allow the controversial medical device to remain on the market.
Dr. Hooman Noorchashm, a heart surgeon from Boston, wrote an email to the FDA on November 1, titled “An Upcoming Ethical Failure At The FDA” (PDF), indicating that he has recently learned that the agency does not plan to issue a power morcellator recall.
Noorchashm and his wife, Dr. Amy Reed, have become strong advocates calling for the FDA to ban morcellation surgery for uterine fibroid removal, arguing that the device poses an unreasonable risk of spreading undiagnosed cancer that may be contained within some women’s uterus.
In the email, Noorchashm describes the FDA plans as amounting to a sacrifice of women in order to kowtow to the gynecological industry and to protect its own controversial fast-track approval process.
About a year ago, the couple sparked a national debate within the medical community over the practice of using power morcellators for uterine fibroid removal after Reed was diagnosed with leiomyosarcoma following such a procedure.
The FDA and other researchers have since estimated that about 1 in 350 women who have uterine fibroids morcellated during during a laparoscopic hyesterectomy or myomectomy may have unsuspected sarcoma. The power morcellators are used to cut up the uterus or uterine fibroids, allowing doctors to remove the tissue through a minimally invasive procedure. However, for women with unsuspected sarcoma, which doctors are unable to detect before surgery, morcellating the fibroids may cause the aggressive cancer to be spread throughout the body.
Despite that information, Noorchashm says that “reliable sources” have told him that the FDA has plans to create a “registry of outcomes” or a “probationary period” for power morcellators, instead of banning them.
“Let the record note that the affected have warned you, the regulators, of an AVOIDABLE mortal harm to women in the US and world-wide and that you stand complacent and very clearly interested in providing the gynecological industry an opportunity to recover – instead of protecting patient safety definitively,” he wrote in the email. “This orientation is a very terrible violation of the public’s trust in the agency to first and foremost protect it from harm.”
Power Morcellation Cancer Risks
Noorchashm and Reed launched a petition to ban morcellators on change.org about a year ago, which has already gained more than 86,000 signatures.
The couple is attempting secure enough signatures to reach President Barack Obama, urging an immediate moratorium on morcellation during minimally invasive hysterectomy surgeries throughout the United States and abroad.
In April, the FDA sent out a warning to doctors, urging them to stop using power morcellators for uterine fibroid removal due to the cancer risks. However, the agency stopped short of banning the devices, allowing gynecologists to continue to use them if they wish.
Over the summer, two panels of FDA advisors determined that there was no safe way to use power morcellators for uterine fibroid removal. However, they could not agree on whether to recommend that the agency demand a power morcellator recall or simply add a black box warning.
Shortly afterwards, Johnson & Jonson’s Ethicon subsidiary, responsible for more than 70% of the power morcellator market, said it agreed with the FDA advisory boards that the devices could not be made safe and issued an Ethicon power morcellator recall, saying that it was completely exiting the power morcellator business.
Since then, doctors and hospitals have dropped power morcellators from use in large numbers and some insurance companies have stopped covering morcellator procedures. However, a number of manufacturers and gynecologists continue to push for availability of uterine fibroid morcellation due to the ability to the supposed benefits of minimally invasive procedures.
According to Noorchashm, the gynecological industry has circled the wagons and is putting pressure on the FDA to keep the devices on the market.
Morcellators were approved through the FDA’s 510(k) fast-track approval program, which allows approval of medical devices which are “substantially equivalent” to devices already on the market without clinical trials or testing to see if they are safe or effective.
The program has taken harsh criticism for becoming a rubber stamp for all but the most radical and new medical devices.
At the FDA advisory committee meeting this summer, Dr. David R. Challoner, chairman of the Institute of Medicine (IoM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process noted that the power morcellator was another child of the 510(k) program that had avoided premarket testing.
The FDA has made no public statement on what it will ultimately decide regarding power morcellators. In August, lawmakers wrote to the agency asking when it planned to issue a power morcellator recall for the companies still making the devices.
On October 8, in a letter to U.S. Senator Kirsten Gillibrand, FDA officials said that they have not decided whether to take any further action, although they still discouraged doctors from using power morcellators for uterine fibroid removal surgeries.
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.
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