Letter to the editor regarding 'Technologies for laparoscopic contained tissue extraction'

TO THE EDITOR:

I thank Dr. Greenberg and Dr. Ajao for the great review article on technologies for laparoscopic contained tissue extraction [Contemporary OB/GYN, October 2014]. But in my opinion, the laparoscopic approach to the fibroid uterus and specifically the tissue extraction controversy is currently a puzzle. The very non-scientific but highly passionate debate on this topic is getting interesting.

After a 2-day meeting held by the Obstetrics and Gynecology Devices Advisory Panel of the FDA to analyze risks, benefits, and the overall clinical role of laparoscopic power morcellators in gynecology, one of the recommended conclusions was to include in the informed consent a disclosure of the risk of disseminating the disease and upstaging uterine malignancy if present. I salute the effort of the panel and agree on the necessity of a comprehensive consent process that includes the risk of occult uterine malignancy that if morcellated will worsen the patient’s prognosis. But how will having the patient sign a consent form change the risk of this unfortunate event? How will it protect the surgeon from the subsequent liability? Who will be responsible for worsening the patient’s survival?

Soon after the aforementioned FDA meeting, the largest morcellator manufacturing company (following what I speculate was a business decision in anticipation of the possible liability, among other reasons) initiated a worldwide withdrawal of the company’s morcellation devices. Some hospitals banned its use. With no scientific evidence to support it, the gynecologists were left without morcellators, which makes the energy, effort, and great creativity showed by Dr. Greenberg and Dr. Ajao along with a large group of smart physicians working on contained tissue extraction in a bag a moot point because we will have no morcellators to do it with. Perhaps the last morcellator remaining in the market should be used to morcellate the tort system and finally build a system based on solid scientific evidence that will protect patients and physicians.

For better or for worse, the morcellator almost certainly will no longer be available. Use of open laparotomy will increase. Unless we keep the morcellator available, we will see increased morbidity and mortality as a result of going back to open surgery, with the subsequent cost to society. This is a real complex dilemma that, in my opinion, could be best answered only using an evidence-based, non-passionate, scientific approach.

Jose Carugno, MD, FACOG

Zephyrhills, Florida

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IN REPLY:

We very much appreciate Dr. Carugno’s impassioned letter and share his frustration with the apparent absence of “a system based on solid scientific evidence that will protect patients and physicians.” That said, we have used the current morcellator controversy as an opportunity to reflect on our practices in this surgical niche and ask ourselves, “Can we do better?”

After months of collaborative reflection, interchange of ideas, and clinical experience, we have come to the conclusion that there may be a better way of extracting excised tissues during minimally invasive procedures using insufflated bags. Have our early techniques been perfected? No. Have they been proven to be safer for patients based on “solid scientific evidence”? No. But to claim that the current standard methods of open power morcellation are perfect is also somewhat less than forthcoming.

We are encouraged by our early experience and excited by the progress in this space. Rather than bemoan the process by which this controversy has developed, we choose to look forward. To expect perfection is unrealistic; to not seek perfection is unacceptable. 

Jim Greenberg, MD

Mobolagi Ajao, MD