When Anita Austin* was told she needed surgery to remove a uterine fibroid, she was presented with two options. Remove it through a large abdominal incision, a major surgery that required about six weeks to recover. Or have a less invasive, laparoscopic procedure utilizing a tool known as a power morcellator. It had a three-week recovery time.
“Who would choose a big incision across your abdomen?” she said, remembering the discussion with her doctor. “He mentioned no downside to the less invasive procedure. Not one of my medical providers mentioned the word cancer. For me, it was a no brainer. I was working full time. It was three weeks instead of six weeks. I said, ‘Let’s do it laparoscopically.’”
It would be a fateful decision. In February of 2011, the then 67-year-old mother of two from Olympia went in for the morcellation procedure. She came out with a “raging” high-grade cancer.
”The tumor cells were Stage 1,” she said. “[But] they blasted it all over.”
Currently in treatment at Seattle Cancer Care Alliance for Stage 4 leiomyosarcoma, Austin is one of dozens of women who have had hidden cancers catapulted into a more advanced form after undergoing power morcellation, a procedure that’s now come under scrutiny by patients, health care providers and the U.S. Food and Drug Administration.
Power morcellators are small bladed devices that mince fibroid tumors (or the uterus) into bits, allowing the surgeon to remove the tissue through tiny laparoscopic incisions in the abdomen. Used during hysterectomy or myomectomy (the surgical removal of uterine fibroids), they have become a popular alternative to full abdominal incisions which come with bigger scars, more pain, blood loss and down time, and a higher risk of infection.
Tragic complications arise, however, when a fibroid is harboring a hidden, undiagnosed cancer such as leiomyosarcoma, a rare smooth muscle sarcoma. Morcellation can then spray microscopic cancer cells throughout the abdominal cavity, essentially “seeding” the patient’s body with disease.
The FDA issued an advisory in April “discouraging” the use of laparoscopic power morcellation (LPMs) during hysterectomy or myomectomy after Dr. Amy Reed, a 40-year-old Boston anesthesiologist and mother of six, launched a very public campaign to ban the procedure following a routine hysterectomy in October 2013 that upstaged her undetected cancer from Stage 1 to Stage 4.
“You have to really grasp how serious [this is] and what morcellation actually does to these outcomes,” Reed said in a video she made with her husband, Dr. Hooman Noorchasm, a cardiothoracic surgeon who has almost single-handedly brought the morcellation issue to the attention of the medical establishment, the public and the FDA. “People say, ‘Oh, you had cancer anyhow,’ which is true. But now my cancer is much worse.”
According to Reed, who was the first patient to report her upstaged cancer to the FDA, leiomyosarcomas are difficult to treat and often resistant to chemotherapy. The median life expectancy for someone with metastatic or Stage 4 LMS, she said, is roughly two years.
When 17 additional cases of upstaged cancers were filed with the FDA, the agency called for a hearing. The two-day meeting, held in early July, included testimony from gynecologists, patients and family members who lost loved ones to LPM-upstaged cancers as well as discussions on how to make the procedure safer, including a possible reclassification and “black box” warning.
The hearing also included a fair amount of back and forth regarding the “weak data” on the number of women actually at risk for hidden uterine cancers which, if morcellated, could prove devastating.
While the FDA put the risk at 1 in 350 and others suggested it was as low as 1 in 10,000, a new study released last week in the Journal of the American Medical Association determined that about 1 in 386 women undergoing a hysterectomy or myomectomy for presumed fibroids had hidden sarcomas.
“This is the best estimate yet with respect to risk,” said Dr. Charles Drescher, a gynecologic oncologist and researcher with Fred Hutch’s Public Health Sciences division.
The study, conducted by Columbia University doctors, used a database of insurance information to identify more than 36,000 women who underwent hysterectomies with power morcellation at 500 U.S. hospitals over a six year period.
Of that number, 99 women received an unexpected diagnosis of uterine cancer post-procedure.
But the bad news doesn’t stop there. An additional 26 cases of other gynecologic malignancies were also found along with 39 cases of abnormal uterine tumors (that may or may not be cancerous) and 368 cases of endometrial hyperplasia (an abnormal multiplication of cells).
“I think this provides important information showing that there is certainly a risk of cancer, not only sarcomas, but endometrial cancer at the time of morcellation,” Dr. Jason D. Wright, lead author and director of gynecologic oncology at Columbia University College of Physicians and Surgeons told the Wall Street Journal.
Although the study did not include follow up data on the status of the 99 diagnosed women, the authors noted that their outcomes require further study and stressed the importance of counseling regarding the “prevalence of cancerous and precancerous conditions” prior to going through LPM.
Unfortunately, even with MRIs, CT scans and biopsies, it’s almost impossible to detect these hidden sarcomas before surgery (endometrial cancers are a bit easier to find). Still some women – like Reed and Austin – weren't informed about the potential for LPM spreading a hidden cancer.
There’s no question the morcellation issue is both tragic and contentious.
Those who want to ban the procedure call it “bad medicine,” pointing to the dozens of women who’ve needlessly died or had their lives hijacked by an upstaged cancer brought on by a popular gynecological procedure.
“It’s very simple,” said Noorchasm in the couple’s YouTube video. “You don’t mince up people’s tumors when you don’t know there’s cancer inside of it. If you do, you’ll cause a Stage 4 cancer.”
Those who want to keep the procedure, on the other hand, feel the benefits of LPMs far outweigh the risks.
“Morcellation has benefited hundreds of thousands of women,” the Society of Gynecologic Oncology wrote in a letter to its members earlier this month. “It is especially beneficial for the two-thirds of American women who are obese, and in whom laparotomy [abdominal surgery] increases both morbidity and mortality. It would be a disservice to deny these or any women this surgical option.”
For Austin, who had her surgery in Olympia, Washington, a lack of information was the most infuriating part.
“The big issue for me is that no one mentioned cancer,” she said, during a recent chemotherapy infusion at SCCA. “Not at all. And I question things. I’d had thyroid cancer [in the early ‘80s] and I would have probably done something different. Given my history, honestly, I should have been advised not to do it.”
Austin said she learned of her uterine cancer as soon as she woke from surgery.
“They did a quick pathology report while I was under to verify it,” she said over the steady rhythm of the chemo pump. “It came back that it was stage 1. The cells had not started to spread and it was high grade, a very fast growing cancer.”
Austin pursued treatment and finished her first regimen of chemotherapy in July of 2011, hopeful the cancer had been contained. But in September of 2012, a new tumor broke one of her vertebrae. It was leiomyosarcoma.
The lifelong runner endured a grueling 11-hour surgery to remove the tumor and fuse five levels of her spine, followed by a cyberknife radiation treatment to destroy the last remnants. After that, it was physical therapy, recovery and a completely rearranged life.
“I’d just taken a great job and only got to do it for 10 months,” she said. “I retired from my hospital bed. But I recovered and after about six months, started running again and got back into my samba group.”
And then the cancer came back. This time, it attacked her psoas muscle next to the repaired vertebrae. Another surgery was scheduled to remove what they thought was a single large tumor but when Austin went to her pre-surgery consult, she received another blow.
“My surgeon read the MRI I’d had the day before and found my whole back was riddled with cancer,” she said. “It looks just like pepper all over my back. It’s in the cervical part, the sacrum, my ribs, my spine.”
Austin, who acts as her own caregiver, now commutes from Olympia to Seattle twice every three weeks to participate in a chemotherapy clinical trial at SCCA. She no longer runs, but she still hikes and walks a few miles with her dog, Toby, each day. Although the chemo zaps her strength, she still makes time for friends, her two grown children (“I’m living to see my kids soar,” she said) and the occasional road trip. She also has plans for the future: samba dancing, nonprofit work and raising awareness about the procedure that has put her in this position.
“I am a fighter,” she said. “And I’m tolerating the trial drug well. I still have hope and still, maybe naively, believe that I can beat this.”
As for the ongoing morcellation debate, Austin has followed it since the story broke in December of 2013. She’s seen the issue gain momentum, spawn both lawsuits and FDA action and has been in close contact with Reed and Noochasm, who are trying to disseminate the risks associated with LPM faster than the microscopic cancer cells can spread throughout the affected women’s bodies.
Austin was one of several patients invited to testify before the FDA, but did not have the strength to travel or endure the sight of so many others in similar straits. She did send a photo of herself which was used in a large poster, showing 30 women – some alive, some dead – who have all had a uterine cancer upstaged by LPM.
“Part of my resistance to this whole morcellation thing is that I don’t like being a victim and it puts you in that victim position,” she said. “That being said, I wouldn’t wish this on anyone and if I can help raise awareness to prevent more heartache, I will do that.”
Drescher said he definitely sympathizes with those who’ve had their cancers upstaged by LPM.
“I understand the sense of betrayal,” he said. “It’s a terrible situation to be in. But I just think there are two sides to this. Unfortunately, the people who were doing these procedures were not thinking about leiomyosarcoma. Their antenna wasn’t up. In their world, all they see is fibroids.”
Thanks to new data, increased awareness and FDA involvement, however, that’s no longer the case.
Johnson & Johnson, which recently has suspended sales of three morcellating devices, called on Wednesday for a voluntary recall return of all devices and many hospitals have willingly brought a halt to the use of LPMs. At UW Medicine in Seattle, OB/GYN surgeons “present the risks and benefits clearly so that the patient has the information to make a decision that feels right.”
Patients who are not comfortable with LPM are encouraged to opt for alternative procedures, such as minimally invasive vaginal hysterectomies.
“There are other approaches that can be used,” said Dr. Robin Jones, a medical oncologist with SCCA. “Minimally invasive doesn’t necessarily equal morcellation. I think that’s important to bear in mind.”
Jones, who in the last eight years of medical practice has seen a number of women with LPM upstaged cancers, said that the JAMA study shows it’s more prevalent than people anticipated and that the FDA was correct in discouraging the procedure.
“It’s a devastating outcome when somebody develops metastatic leiomyosarcoma,” he said. “It’s basically incurable at that stage. It’s very, very important for women to carefully consider morcellation. And it’s a very good that this has now finally come to the forefront.”
Austin feels much the same.
“At first I was saying, women at least need to be informed of the risk,” she said. “But now I’m leaning more toward having it stopped for hysterectomies. There are too many unknowns. Until science knows more about it, we should protect all women from this.”
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*Editor's note: Anita Austin died of her metastatic leiomyosarcoma in October 2016.
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Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has also written extensively about health issues for nbcnews.com, TODAY.com, CNN.com, MSN.com, Columns and several other publications. She also writes the breast cancer blog, doublewhammied.com.Reach her at firstname.lastname@example.org.