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| Ethicon's Morcellex Sigma Tissue Morcellator--Courtesy of Johnson & Johnson |
Amid mounting backlash over the use of power morcellator devices in women undergoing certain gynecological procedures, new evidence shows that a report issued last year by a professional association of surgeons recommending the tool to physicians may have been biased.
As The Wall Street Journal reports, the AAGL--formerly known as the American Association of Gynecologic Laparoscopists--said in a May 2014 report that power morcellation "remains safe when performed by experienced, high-volume surgeons." But an AAGL executive officer, New York-based surgeon Arnold Advincula, joined the final discussions of the report even though he had received consulting fees from a morcellator maker, violating the association's conflict-of-interest policies, Ceana Nezhat, the association's president at the time, said in a May 7 email.
"Given the importance of COI surrounding this topic, and the potential press involvement in dissecting COIs of our board members in relation to morcellation, I am shocked the organization would allow their own policies to be 'flexible,'" Nezhat said in the email, as quoted by the WSJ.
The AAGL started beefing up its conflict-of-interest policies in 2013, adopting a rule that forbid executive committee members from doing paid work for drug or device companies. But Advincula and other incumbents on the committee were exempted from the rule under a grandfather clause that Advincula lobbied for himself.
Advincula, chief of gynecological surgery at Columbia Medical Center, received at least $50,000 for speaking and other services in the last 12 months from Blue Endo, a morcellator seller. He said through an AAGL spokeswoman that his consulting relates to sharing clinical expertise and collaborating with scientists and engineers. Lenexa, KS-based Blue Endo did not comment to the WSJ.
The AAGL today maintains that power morcellation with "appropriate informed consent should remain available to appropriately screened, low-risk women," the WSJ reports.
Meanwhile, the FDA and industry is responding to public outcry over the devices. In July, Johnson & Johnson ($JNJ) pulled its related product from the global market, months after suspending sales for the device. In November, the FDA updated its safety guidance for the devices, recommending against using laparoscopic power morcellator tools in the "majority" of women undergoing a hysterectomy or the removal of uterine fibroids.
- read the WSJ story (sub. req.)