Morcellation Should Be Banned, Harvard Surgeon Says

An Expert Interview With Hooman Noorchashm, MD, PhD

Stephanie Cajigal; Hooman Noorchashm, MD, PhD

Disclosures

June 10, 2014

Medscape: What morcellation alternatives should the gynecology community consider?

Dr. Noorchashm: Laparoscopic and robotic-assisted hysterectomies are possible without morcellation. This is where adopting some of the practices used by minimally invasive general and thoracic surgeons can really help gynecologic surgeons. They can dissect the uterus and remove it intact in a sealed bag, either transvaginally or through a mini-laparotomy. There is no reason to put a meat grinder inside someone's body to get out a large mass.

Medscape: Is there a difference in the prognosis for women whose surgeries are performed using an open procedure vs those whose surgeries would include morcellation?

Dr. Noorchashm: A surgical cure for localized and early sarcoma can only be achieved with en bloc resection with good surgical margins. This is a fundamental principle in general and thoracic surgery. Morcellation is a dangerous violation of this principle because it converts an early-stage sarcoma, a stage I sarcoma, into a stage IV sarcomatosis. Gynecologists obviously don't recognize this because of their limited training in general surgery.

A stage I sarcoma has an entirely different prognosis from that of a local regionally disseminated stage IV sarcoma. According to Surveillance, Epidemiology and End Results (SEER) data, the 5-year survival rates are in the order of 60%-90% for stage I disease, compared with 15% for stage IV disease.[5] Any medical oncologist worth their salt who's taking care of these morcellated patients will tell you that a morcellated uterine sarcoma is an absolute disaster to manage. It kills people. It erodes through wounds. It erodes through organs.

Medscape: What about women who have fibroids, but don't want a hysterectomy and want to preserve their fertility? Is it possible to manage and remove them while also addressing the risk for cancer?

Dr. Noorchashm: A woman who wants a uterine-sparing operation should be subjected to extensive preoperative and intraoperative biopsies and imaging. That's what we do in other anatomical regions.

We routinely do image-guided biopsies. I think our radiology colleagues are really well capable of providing biopsy tissue using CT guidance. They can biopsy some very difficult anatomical locations. These uterine fibroids are relatively large and could be accessed by radiologists. I think any radiologist would tell you that these are amenable to CT-guided biopsy.

Certainly, intraoperative biopsies can be performed by the surgeon. If there is reasonable pathologic certainty that no cancer is present on biopsy, then they can go ahead and perform a selective myomectomy. But even in those cases, morcellation should not happen. The intact noncancerous fibroid should be put in a bag, and the bag should be removed through a small incision -- the same way we do it with gallbladders and any other tissue that we remove laparoscopically.

The uterine fibroids are never biopsied. Why? Breast masses are biopsied. General surgeons routinely send patients for CT-guided biopsies. Thoracic surgeons do the same thing. Why aren't these surgeons doing it? It goes back to the concept of practicing and training in a silo away from other surgeons.

Medscape: Recently, 3 medical societies -- ACOG, AAGL, and the European Society of Gynecologic Endoscopy (ESGE) -- released morcellation guidelines. Could you provide us with your assessment of these guidelines?

Dr. Noorchashm: I think they represent defensive statements of industry-wide negligence. These statements all basically acknowledge that a much higher risk for cancer than previously thought exists in women with symptomatic fibroids. The FDA has come out now with 1 in 350. Most of these organizations are saying 1 in 500.[6,7] The previously held number was 1 in 10,000 to 20,000.[3]

As the case may be, the statement also acknowledges that the women with occult sarcomas can't really be identified with any degree of certainty. But what's incredible is that they then go on to endorse the continued use of morcellation, which they admit could cause the spread of the cancer to a deadly stage IV.

Medscape: In April, the FDA issued a statement saying that laparoscopic power morcellators shouldn't be used for hysterectomy or myomectomy in most women with fibroids. Do you think this is a step in the right direction?

Dr. Noorchashm: Yes; it's a very unique statement. The FDA doesn't put out advisories very lightly. These are a group of public health experts, who have been alerted to a severe hazard and understand it. They're putting an avoidable mortality hazard at 1 in 350[2] -- which is, as I said, off the Richter scale. Frankly, I'm surprised they haven't pulled the devices off the market yet. I hope they do so soon, because otherwise the FDA will need to answer to the next unsuspecting woman and her family who is given a diagnosis of stage IV cancer using an FDA-approved morcellator.

Medscape: What do you have planned next for your campaign?

Dr. Noorchashm: Amy and I are going to continue to fight this until all women are secured from this practice. We also intend to demonstrate to the US Congress that the 510k legislation for medical device approval [that established the process under which the first power morcellators were approved] is defective and requires a very serious overhaul. Also, it's obviously a complex issue, but I think that there is a role for the court system in weighing in at a systemic level to protect the public from industry-wide negligence -- that is, if the gynecologic specialty does not effectively self-regulate and eliminate this hazard.

Medscape: Do you have any general estimates on how many women might have had their cancers morcellated?

Dr. Noorchashm: Amy and I have communicated with and confirmed about 120 women. But let's do the math.

According to ACOG and other specialty leaders, about 55,000-80,000 hysterectomies are performed with morcellation each year.[6] That's probably an underestimate and excludes the myomectomies that are being done with morcellation. The FDA is saying that the risk for an occult malignancy in a woman with symptomatic fibroid disease is 1 in 350.[2] Let's be generous and call it 1 in 400. So, 80,000 divided by 400 is 200 women.*

That's 2 jetliners filled with women going down every year because of an avoidable practice. If 2 jetliners went down every year for an avoidable practice, I would guarantee you that people would be up in arms and they would shut down whatever is causing the error. It's simple math, and it's very real. These women are real.

*In an email to Medscape, ACOG says it disputes that a figure could be calculated, based on the information that exists. According to the email, "The data on the number of morcellation procedures is actually not stated in ACOG's Special Report on morcellation or in any ACOG publications. ACOG has confirmed that, in fact, there are no documented, clear data available from any sources, leading ACOG to encourage the FDA to call for the establishment of a prospective registry."

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