But Dr. Brown said that while she agreed with those principles, since fibroids are so common, banning the use of morcellation could result in “hundreds of thousands” of hysterectomies.
Specimen collection bags were used when LPMs were first introduced for gynecologic indications, but dropped over time. Use has increased recently as a result of the increased attention to the risks, but there is no evidence that bags are effective in reducing the risk of disseminating malignant cells in the peritoneal cavity, in the case of an unsuspected malignancy.
“If you are going to morcellate, and it can be done safely in a bag, then that should be encouraged,” said panelist Dr. Keith Isaacson, medical director of the Center for Minimally Invasive Gynecologic Surgery at Newton (Mass.) Wellesley Hospital. More work is needed to evaluate bags and the techniques for their use, and to determine how easy it is train clinicians in how to use them safely, he added. “I still believe that intuitively – and that’s all we have is intuition here – that it more likely mitigates the risk of upstaging a tumor if you morcellate within a containment system, such as a bag.”
The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts, although occasionally a panelist is given a waiver, but not at this meeting.
Adverse events related to LPMs or other medical devices should be reported to the FDA.
emechcatie@frontlinemedcom.com
This article has been updated 7/14/2014.