Surgery for the Greatest Number

This year, more than half a million women in the United States will undergo hysterectomies. The majority will be between 40 and 55 years old, and most will have the surgery for fibroids, benign growths in the uterus that can cause pain, bleeding, and other symptoms. Five years ago, only about 12% of these surgeries were performed laparoscopically, done through incisions just big enough to fit a scope and tiny camera. Last year, nearly 30% were done that way, and the numbers were considered likely to rise.

Laparoscopy is fast,  has fewer pulmonary complications because the anesthesia is lighter and the incisions smaller, and hospital stays are shorter or avoided entirely for the same reasons. So it is more convenient and is cheaper with a faster recovery time. A morcellator has become standard instrument in laparoscopic surgeries to remove fibroids, the uterus, or both. The "morcellator," from the French to subdivide ("morsel" has the same origin), breaks the tissue into smaller segments so it can be collected and removed, preventing you from having to make a larger incision.

Cancer in a fibroid is rare--in women with symptomatic fibroids the number may be 1 in 450--and, while it is usually hard to find before surgery, everyone has an MRI and fibroid biopsies to try to assure there is no cancer, usually a leiomyosarcoma. If a woman's uterus is morcellated inside her body, cancer cells are spewed around the abdomen, where they cling to internal organs and, inevitably, grow. The difficulty is the screening MRI and biopsies are usually not terribly accurate so a tumor can slip through and be morcellated with the fibroid. Leiomyosarcoma is so rare there are no protocols for treating it, no best practices, no good survival statistics. Some doctors do nothing, waiting to see if it comes back; some start chemotherapy to try to stave it off; some schedule surgery to clean out anything that's already growing. But some of these come back, spread and kill the patient who would otherwise be cured with the older, open surgical procedure.

So, the problem: What do we do with a successful, cheap, convenient procedure with generally good results but in which there is a small number of women who have terrible results? When is a procedure safe and worthwhile?

Safe and worthwhile are tough requirements. Aspirin is worthwhile but harms some people so, is it safe? Some have fatal reactions to penicillin; could it be approved now? When something makes medicine cheaper and more convenient, what has to happen to prove it's not worth it?

Enter Dr. Amy Reed and her husband. Dr. Reed, an anesthesiologist in her mid-thirties with six young children, had a fibroid and went to discuss hysterectomy. While she preferred an open operation, she agreed to laparoscopy with morcellation. After negative MRI and biopsy she underwent an uneventful hysterectomy. A week later leiomyosarcoma was reported in the removed tissue. Since Reed's surgery, at least five other women around the country whose cancers were upstaged by morcellation have come forth. 

Reed is a high profile physician in Boston and so is her thoracic surgeon husband, Dr. Noorchashm. Her husband started a campaign against the procedure, speaking at every opportunity.

Eventually, crediting Reed's husband's influence, the FDA issued an advisory strongly discouraging the use of morcellation. Doctors and administrators maintained that what happened to Reed was unfortunate but incredibly rare and that it didn't make sense to abandon morcellation—a convenient and widely usable technique—because of such an unusual occurrence. The largest professional organization for ob-gyn surgeons, the American Association of Gynecologic Laparoscopists, issued an official statement disagreeing with putting limits on the procedure. More institutions, including the University of Pennsylvania Health System and Cleveland Clinic, changed policies and began to limit the procedure. Eventually Johnson & Johnson, the biggest morcellator maker in the United States, suspended production and sale of the tool.

So when is a good therapy for the vast majority of people not a good therapy?

And the unfortunate Dr. Reed? After extensive surgery and chemotherapy, her disease is back.