Tuesday, July 22, 2014
Last year Martha Montalvo-Ariri underwent a routine hysterectomy to help treat painful uterine fibroids. During surgery, her doctor used a morcellator, a device that cuts the tissue into pieces so it can be removed through small incisions.
Ten days after the procedure, Montalvo-Ariri was diagnosed with a rare and aggressive form of uterine cancer called leiomyosarcoma. Even more devastating, the rotating blade of the morcellator had scattered cancerous tissue fragments around her abdomen and pelvic area, accelerating the disease’s progression.
“None of the forms I signed mentioned anything about cancer,” said Montalvo-Ariri, a 46-year-old mother of four in Riverside, Calif. “They said it was in and out, very easy, and you’re back to your life. Instead, they took my life away.”
Cases such as Montalvo-Ariri’s have raised significant concerns over the use of power morcellation to remove a woman’s uterus or fibroids. Cleared for gynecological surgeries in 1995, morcellators facilitate minimally invasive procedures that can reduce women’s pain, recovery time and complications.
In April, however, after reviewing new data, federal regulators urged doctors to stop using morcellators, because if cancer is present the device can spread malignant cells beyond the uterus and worsen a patient’s chance for long-term survival. In response, a leading manufacturer of morcellators, Johnson & Johnson’s Ethicon subsidiary, suspended sales of the device.
Now medical providers are wrestling with a difficult decision: Should they offer a procedure that has proven benefits for the majority of patients but also carries a rare but deadly risk for a small number?
If women could be tested for all uterine cancers beforehand, doctors could avoid morcellation with some patients. But without doing surgery, there’s no reliable way to predict whether a woman with fibroids has a uterine sarcoma, notably leiomyosarcoma, according to the U.S. Food and Drug Administration.
Many hospitals around the country have stopped using morcellation at least temporarily.
But others have said morcellation still has a role in gynecological surgery and that, with appropriate counseling, patients can decide for themselves. Last month Northwestern Memorial Hospital reinstated the technique under “controlled circumstances” and for those who might be at higher risk with a traditional open procedure. Advocate Health Care lifted a systemwide ban in May.
Three professional medical associations acknowledge the risk but say morcellation should be an option in some cases because minimally invasive procedures cause fewer complications, injuries and deaths than open surgery.
Recently the FDA held a public meeting to discuss how to make morcellation safer, including whether a black box warning should be added to the product labeling. The agency has not yet publicly announced any conclusions.
Meanwhile, a growing chorus of doctors, clinicians and leiomyosarcoma patients and their families want the device banned, arguing that morcellation is reckless and viable alternatives exist.
“I’ve been seeing women harmed by this thing for the last eight years,” said Dr. Robert Lamparter, a pathologist at a small Pennsylvania hospital who wrote a letter to the FDA requesting the device’s clearance be revoked. He said he has analyzed tissue in five cases in which an unanticipated cancer was morcellated.
“I’m just horrified,” Lamparter said in an interview. “It’s not just another complication. There is no acceptable injury or death rate for an elective surgical device, even if it’s wonderful for those who aren’t harmed.”
About 600,000 hysterectomies are performed in the U.S. each year. Research suggests about 40 percent are done to remove presumably benign or noncancerous fibroids that are causing heavy bleeding, pelvic pressure or pain, or other symptoms.
The number of morcellations is not tracked, prompting calls for a nationwide registry of gynecological surgeries that would include information on the devices used.
The safest and most cost-effective way to remove the uterus is through a vaginal incision, according to the American College of Obstetricians and Gynecologists. But that isn’t possible with enlarged uteruses or large fibroids unless the tissue is cut into small pieces with a power morcellator or by hand using a scalpel.
The traditional surgical choice involves a 5- to 7-inch incision in a woman’s abdomen. This method offers doctors the clearest view but like all surgeries carries a higher risk of infection and complications such as blood clots. Though the overall mortality risk is low, research suggests abdominal hysterectomy patients die three times more often than those who undergo a laparoscopic procedure.
The risks of morcellation are difficult to assess. The FDA estimates that about 1 in 350 women who undergo a hysterectomy or fibroid surgery have an undetected form of uterine cancer. But those numbers have been questioned because the studies are small, leiomyosarcoma is extremely rare and the data aren’t broken down by age.
Complicating the issue: Even without morcellation, the outlook for women with leiomyosarcoma is grim. The five-year survival rate for women at stage 1, when the cancer is confined to the uterus, is approximately 50 percent, according to the National Cancer Institute. (Once the cancer has spread, the rate is about 15 percent.) For most other gynecologic cancers, the five-year survival rate is 90 percent if the tumor is contained.
Abandoning morcellation “would set us back to offering procedures with larger incisions and be a detriment to women surgically,” said Dr. Jessica Shepherd, director of minimally invasive gynecology at the University of Illinois at Chicago College of Medicine. “There is always risk in a procedure. The most important part is the discussion women have with the physician before having it.”
The morcellation controversy gained national attention after Amy Reed of Boston underwent an elective hysterectomy at Brigham and Women’s Hospital last October. Reed, an anesthesiologist at Harvard Medical School who has six children, said she had preoperative biopsies, ultrasounds and MRIs to rule out cancer. After the procedure, however, she was diagnosed with advanced leiomyosarcoma; morcellation had seeded her abdomen with cancer.
Dr. Kimberly Kho, an assistant professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center, encourages surgeons to avoid morcellation until more safety data are available. If morcellation is under consideration, “it’s imperative to tell patients it could spread undetected cancer, worsen prognosis and that the device itself can cause injuries,” she said.
Montalvo-Ariri, who is now on her fourth type of chemotherapy treatment, said she would have welcomed that information.
“I’ve had four cesarean sections, and I bounce back from surgery pretty quickly; I would have had no problem with them opening me up the old-fashioned way,” Montalvo-Ariri said. “That was the most devastating thing.”