A doctor responsible for publishing an opinion on power morcellators was found to have been paid by a power morcellator manufacturer. This revelation came after the U.S. Food and Drug Administration (FDA) issued a warning concerning power morcellators stating that many women had developed morcellation cancer after undergoing a surgery with the device.

The power morcellator is a tool that can be used for hysterectomies, fibroid removal surgeries, and other similar procedures. The tool enters the body through a small incision in the abdomen and cuts and removes the tissue. Power morcellation surgery was supposed to be safer and have a shorter recovery time when compared to traditional hysterectomies.

However, many women who underwent fibroid removal surgery had undiagnosed cancer in their uterus or uterine fibroids. In several cases, the cancer was spread throughout the body when the power morcellator was used. The high number of power morcellation cancer cases caused the FDA to issue a safety communication warning on April 17, 2014.

One in 350 women who underwent fibroid removal surgery with a power morcellator reportedly developed morcellation cancer. The dangers surrounding the surgical tool caused many manufacturers to recall or cease promoting their devices. Johnson & Johnson, who had the largest claim in the power morcellator market, recalled its devices after many cases of morcellation cancer were found.

A large number of power morcellator lawsuits have been filed as well.

Power Morcellation Controversy

In May 2014, a report published by the American Association of Gynecologic Laparoscopists (AAGL) claimed that power morcellators are “safe when performed by experienced, high-volume surgeons.” This opinion, however, was influenced by one Dr. Arnold Advincula who, as it was later discovered, received payment from a power morcellator manufacturer prior to making his opinion at the AAGL board discussion.

Advincula disclosed that he had received at least $50,000 from Blue Endo, a manufacturer and seller of a power morcellator. He claimed it was for speaking and other services.

The AAGL spokeswoman noted, “It is inevitable there is something going to be conflicting,” but that the agency “should and does listen to all points of view before it reaches its formal position.”

The AAGL is, however, strongly against conflict-of-interest. In 2013, it enforced a policy which prohibited executive-community members from receiving money from drug or medical device manufacturers. Advincula was allegedly exempt from this policy due to a grandfather clause.

In March 2014, the AAGL reviewed power morcellator safety and chose 13 doctors for the task force. They were doctors who specifically had no financial ties to companies involved the sale or manufacture of power morcellators.

Though not on the task force, Advincula was a known supporter of power morcellators. He was requested to not discuss the review. This report received some push-back.

Dr. Ceana Nezhat, president of AAGL, later stated, “Unfortunately, Dr. Advincula did not recuse himself from the discussion and the minutes will reflect such, contrary to the statement released with the report. … In hindsight, had we elected to follow zero tolerance regarding [conflict of interest] with no grandfather clause … we would not have this current problem.”

The AAGL recommended that power morcellators remain an option. However, with increasing numbers of lawsuits, comments by government regulators and the refusal of insurers to pay for their use, the use of morcellators is becoming more and more limited.