BALANCING ACT The FDA says morcellators can spread cancer in hysterectomy patients, but do the benefits of minimally invasive hysterectomy outweigh the risks?

The sweeping nature of the recent FDA advisory recommending that the use of morcellators for hysterectomies be discontinued or severely restricted is both surprising and disappointing, to say the least. To those of us who are experienced in laparoscopic minimally invasive surgery — those of us who've witnessed its tremendous benefits firsthand — this feels like a rush to judgment.

Morcellators — powered instruments that can be inserted through small ports in the abdominal wall in the course of laparoscopic hysterectomies or myomectomies — let us break up large pieces of tissue so that they can be safely removed without large abdominal wall laparotomy incisions or large incisions in the apex of the vaginal vault.

My group, Walnut Hill OB/GYN Associates, practicing at the Texas Health Women's Specialty Surgery Center of Dallas, has performed more than 2,000 laparoscopic supracervical hysterectomies (LSH) and we've had zero issues with morcellation. There have been no adverse incidents or injuries to bowels, bladders or blood vessels of surrounding pelvic organs, nor have we discovered a single unsuspected uterine sarcoma.

By contrast, open-incision laparotomy, which will dramatically increase as a result of this advisory, has been proven to increase the risk of infection, blood loss, and collateral injury to the ureter, bladder and bowel, as well as death due to post-operative complications, including DVT and pulmonary embolus. It will increase the length of hospital stays, as well, and on the order of 4- to 20-fold. Many minimally invasive surgeons haven't had to keep a patient overnight after an LSH in years. Before the introduction of the morcellator, all patients stayed overnight.

It's worth noting that as gynecologic surgeons, we have no financial incentive to defend the use of morcellators. The fact is, open cases almost always provide significantly better compensation. But we do have a commitment to provide our patients with the best and safest care. This advisory has the potential to severely limit our ability to do that.

Did the FDA overreact?
Many of us suspected that something along these lines was coming, once a high-profile case involving a rare uterine cancer made it to the morning television talk shows. (A Massachusetts couple, both doctors, had taken a very public stance on the issue.) Unfortunately, the FDA has a history of occasionally issuing judgments about complicated clinical matters that are fueled by public perception rather than research-supported conclusions. Many will remember the agency's ban on silicone breast implants despite a dearth of clinical evidence. The tidal wave of ensuing litigation sent a chill through the entire country's medical community, and it took the FDA over 15 years to reverse its decision.

We expected something, but we were surprised by the forcefulness of this advisory. Instead of a reasoned suggestion that physicians responsibly warn patients about the small but real dangers involved with morcellators, the FDA chose to make a sweeping recommendation that has the potential to increase the morbidity and mortality for hundreds of thousands of women about to undergo hysterectomies.

It's true that in extremely rare instances —most studies suggest about 1 in 1,000 cases — leiomyomatas (benign uterine fibroids) have leiomyosarcomas hidden within them. Sarcomas are extremely aggressive cancers that tend to spread quickly to distant locations through blood and lymphatics, rather than spreading contiguously. Unfortunately, unless a sarcoma is found serendipitously when it is little more than microscopic and in an intact hysterectomy specimen, the disease is lethal. In other words, once a sarcoma is diagnosable, it is almost always too late for any surgical intervention to improve the dismal prognosis.

The hypothesis that morcellators, when used on a uterus that contains a sarcoma, will (a) spread the tumor and (b) negatively impact the prognosis, is largely unfounded by any controlled prospective research. While it has been suggested this might be the case, it is largely speculative.

Furthermore, the FDA advisory states that the incidence of sarcoma is 1 in 350, which many feel to be nearly 3 times the actual rate. Banning a procedure that we've all seen to be extremely beneficial for thousands and thousands of patients simply does not seem like the best course of action.

The alternatives?
The FDA advisory suggests that providers "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."

Current specimen bags are not available in large enough or malleable enough material to protect the pelvis without dangerously restricting visibility and/or risking entrapment in the blade of the morcellator. The risk of inhibiting optimum visualization and mobility of the instruments is huge, and unless you've performed hundreds of these procedures, you're likely to have little concept of the technical difficulties involved. As far as I'm concerned, using currently available bag technology in the unlikely hope of restricting a prohibitively rare cancer, while at the same time significantly increasing the risk of injury to the patient, seems inadvisable.

The remaining alternatives for large fibroid uteruses include only open laparotomy, or total vaginal hysterectomy with manual morcellation or debulking in vivo. In the hands of all but a very few surgeons, this approach carries a significant risk of bleeding, injury to bladder or bowel, and particularly, ureteral damage. For the smaller uterus, a total vaginal hysterectomy (TVH), laparoscopically assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH) may be options. But none of these leaves the vagina intact and the cervix and attached ligaments in place, and all carry a risk of vaginal dehiscence and vaginal cuff hemorrhage.

Though the advisory is bound to have a chilling effect, I think eliminating morcellators is shortsighted. Our goal is to help patients, not make medico-legal decisions in response to an overbroad FDA advisory. After all, most institutions haven't removed mesh as an option for total vaginal vault prolapse, despite "black box" warnings.

Officially, we've been "discouraged" by the FDA from using "laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids." The FDA also says we should thoroughly discuss the benefits and risks of all treatments with patients, and that individual patients for whom careful benefit-risk evaluation shows that laparoscopic power morcellation is considered the best therapeutic option need to be informed that their fibroid(s) may contain cancerous tissue and that morcellation can spread the cancer.

Have we always had that conversation? Perhaps not, because the general perception has been that it's extremely rare, and that the nature of the disease made the method of removal largely irrelevant due to the dismal prognosis. But given the increased concern that morcellation of a fibroid containing an undiagnosed uterine sarcoma could adversely alter the prognosis for even one patient, all patients should be warned of this possibility and offered alternative approaches, even if the alternatives are potentially more morbid and not minimally invasive.

Do no harm
The American Association of Gynecologic Laparoscopists (AAGL) has responded to the advisory, acknowledging that it's "of paramount importance that our patients are counseled appropriately about the dissemination risks associated with intracorporeal morcellation." But the AAGL also stresses the importance of having patients and the public "recognize the benefits provided to the vast majority undergoing minimally invasive surgery."

We've always informed patients of the risks of bleeding, infection and injury to the bowel, bladder, ureter and major blood vessels. There's also the risk that the procedure could end up an open laparotomy, because even with minimally invasive techniques, pelvic and uterine architecture and/or adhesions might occasionally preclude the successful use of the morcellator. Certainly sonographic imaging detailing the dimensions and position of the pelvic mass or masses, meticulous documentation of these findings, as well as a careful history and physical are warranted. Unfortunately, suggested methods for distinguishing a tiny uterine sarcoma from surrounding leiomyomata are largely untested and expensive. And since 40% of women have fibroids, conducting an MRI for every patient would be prohibitively expensive to society as a whole, probably not beneficial, and would do little to detect what is usually a microscopic pathological diagnosis based on mitotic cell count post-operatively. The question we should be addressing is whether a sweeping condemnation of morcellation in laparoscopic hysterectomies is more likely to harm or help patients on the whole.