How Morcellation Device Got Surgeon Group Blessing
March 12, 2015 – The American Association of Gynecological Laparoscopists (AAGL) recently found itself in the middle of the controversy over the safety of morcellation devices. Despite dire warnings concerning the dangers of the device, the professional association of surgeons publicly declared their support for its use, surprising many in the medical community. The report was called into question when it was revealed that one of the contributing members has worked with Blue Endo, a morcellator sales company.
AAGL issued the report in May 2014, shortly after the US Food and Drug Administration went public with its concern linking cancer risk to the device. In the notification, the FDA warned physicians to:
- Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.
- Not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.
- Carefully consider all the available treatment options for women with symptomatic uterine fibroids.
- Thoroughly discuss the benefits and risks of all treatments with patients.
- For individual patients for whom, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option:
- Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
- Be aware that some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.
AAGL’s report stated the surgeons believed use of morcellation “… remains safe when performed by experienced, high-volume surgeons.”
Report Impacts Opinions of Surgeons throughout the Country
Surgeons throughout the country accepted the report and let the opinions within guide their decisions concerning morcellation. It was later revealed the report was not completely unbiased: Arnold Advincula, an executive member of the group, had received consulting fees from a maker of the device and many now question if that affected his opinion.
Dr. Advincula is Vice Chair of Women’s Health – Gynecologic Surgery & Urogynecology at Columbia University Medical Center and held leadership positions in AAGL beginning in 2012, including that of president beginning in 2015. Some members of the AAGL believed Dr. Advincula’s participation in the report was a conflict of interest. The group publicly stated it allowed Dr. Advincula to participate in the discussion because it wanted to consider all points of view regarding morcellation.
Ongoing Concerns about Morcellation
The debate over the safety of the morcellation device is nothing knew. Dozens of cases have been reported from women who underwent morecellation procedures and later appeared to have developed cancer. Medical experts now believe the women likely had undiagnosed cases and the actions of the device led to the spread of cancer cells. After the FDA issued its warning, many hospitals stopped using them and Johnson & Johnson, the largest maker of the device, stopped production.
AAGL strengthened its conflict of interest provisions in 2013, forbidding executive committee members from accepting paid work from drug or medical device companies, but exempted those who were already participating in such work, including Dr. Advincula. Columbia University Medical Center’s website reports he received at least $50,000 for speaking engagements and consulting from Blue Endo.
As the report was being developed, Dr. Advincula, then vice president of AAGL, urged the group to defend morcellator use. In an April 18, 2014 email to board members he stated, “We need to be very decisive about where we stand and not be afraid to disagree with FDA if we believe mechanical powered morcellation has a place,”
Dr. Advincula did not participate in the vote regarding the report, but did participate in discussions. Another doctor had recused himself from both voting and discussions based on similar circumstances and requested Dr. Advincula do the same.
The report resulted in at least one hospital’s decision to continue morcellation use. Baptist Health had intended to stop using the tool, but reconsidered after Ricardo Estape, medical director of the Center for Robotic Surgery at Baptist Health South Florida shared information from the report. He stated, “This is a group of physicians who do a lot of these procedures and they’re the ones you need to be listening to.”
Today, the hospital continues morcellation use, based on the reports conclusion that “…all current methods of tissue extraction should remain available.”
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.