Latest Study Reveals Incidence of Cancer Spread Due to Power Morcellator Surgery
The study, conducted by Kaiser Permanente’s Jasmine Tan-Kim, reviewed a large number of laparoscopic hysterectomies, and found 941 women in the group who specifically had power morcellator surgery. Six women in total were found to have or have developed uterine cancer within 2 to 7 years after their surgery to remove fibroids.
Power morcellator surgery is supposed to be a simple, non-invasive procedure in which the laparoscopic device is used to find fibroid tissue in the uterus, and grind fibroids down to be removed through a small incision in the abdomen. Uterine fibroids can cause pain and annoyance with menstruation, so many women choose to undergo the surgery to reduce those complications. However, grinding down fibroids, which are assumed to be non-cancerous, can actually cause the spread of cancer when the tumor is ground down.
According to FDA estimates, as many as 1 in 350 women have undetected uterine cancer that can look like fibroids, and the cancerous tissue can be ruptured with power morcellator surgery. The previous rate was estimated at 1 in every 7,000 women. Because of the seriousness of undiagnosed uterine cancer, in November 2014, the FDA announced that it could not recommend power morcellator surgery for most women.
Amy Reed, a physician and also a victim of uterine cancer spread due to power morcellator fibroid surgery, says the problem with morcellation makes sense.
“In animal models, we take cancer cells and we put them in places and then they grow. That
s by definition deregulated growth- thats how cancer works. So of course if you chop it up, it spreads,” she said.
Mrs. Reed and her husband testified before the FDA regarding the dangers of power morcellator surgery, even going so far as to call the devices a “public health hazard.”
A recent investigative report published by the Wall Street Journal also raises concerns about how power morcellators were approved for the US market in the first place. The American Association of Gynecologic Laparoscopists has repeatedly defended morcellation, including last May after the initial controversy around uterine cancer erupted, insisting that morcellation “remains safe when performed by experienced, high-volume surgeons.”
However, the AAGL has experienced problems with conflicts of interest among their board of directors. In 2013, the group began to strengthen its conflict of interest provisions to forbid executive-committee members from accepting paid consulting work for drug or device companies, as that would skew physicians’ opinion on safety issues.
New York surgeon Arnold Advincula, who has held leadership positions with AAGL since 2012, has held the position of president since December. His website states clearly that he accepted $50,000 for speaking and other services from Blue Endo, a company that manufacturers power morcellators. Dr. Advincula has been one of the most vocal advocates in favor of continuing power morcellation surgery in the US.
“Unfortunately, Dr. Advincula did not recuse himself from the discussion and the minutes will reflect such, contrary to the statement released with the report,” another executive committee member stated after the May 2014 vote. “In hindsight, had we elected to follow zero tolerance regarding COI with no grandfather clause, as I suggested, we would not have this current problem.”
The Strom Law Firm Protects Citizens Harmed by Delayed Defective Product Recalls
The attorneys at the Strom Law Firm keep a close watch on recalls of dangerous and defective product recalls in the US. We aim to protect our clients’ health and safety, and hold manufacturers to the highest possible standard of safety. If you or a loved one have experienced severe, life-limiting side effects from a defective product or drug, and believe that your pain stems from a product recall that came too late, you may be entitled to compensation. The Strom Law Firm can help. We offer free, confidential consultations to discuss the facts of your case, so contact us today. 803.252.4800.