In mid-April, the U.S. Food and Drug Administration issued a safety warning about the use of certain types of laporoscopic techniques. The devices – called morcellators – use small blades to break apart tissue so it can be removed through small incisions.
This procedure has been widely used to remove the uterus (hysterectomy) or to remove uterine fibroids (myomectomy). Laparoscopic hysterectomies and myomectomies have become popular because they are less invasive and offer shorter post-operative recovery time; they also pose a lower risk of infection compared to abdominal hysterectomy and myomectomy.
The problem with the procedure is that if the tissue being removed turns out to be cancerous, the blading process can spread that tissue around the body. Spreading the tissue can worsen the cancer, thus downgrade the patient’s prognosis for recovery from the cancer. Depositing the tissue in other areas of the body can also lead to other painful adverse events.
Complicating the problem is the fact that this type of cancer that hides in fibroids can’t be detected preoperatively – unlike cervical and endometrial cancers.
In its safety warning, the FDA stated:
If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
An article in the Journal of the American Medical Association (JAMA), noted that gynecologic surgeons, like other surgeons, have embraced laparoscopic surgical techniques “because they offer quicker recovery, less postoperative pain, and fewer wound complications than open procedures.”
So the perceived benefits are clear – but what about the risks? Experts say that prospective patients are often not told about these risks before consenting to the operation. In order to give true informed consent, patients need to be told of the hazards as well as the benefits of a procedure.
The JAMA article concluded: “inadequate experience and lack of data about adverse events is in part a result of a system that permits adoption of innovative surgical techniques without systematic ascertainment of harm.”
One 53 year-old patient who became aware of the risks did make a different choice. The Wall Street Journal reported on a scientist in Colorado who read about the debate and asked her doctor to use an alternative procedure. At her urging, the doctor removed her uterus vaginally, without a power morcellator. The results show she indeed had uterine sarcoma in the removed tissue – and she is now cancer free.
Another patient was not so lucky. Dr. Amy Reed, a 41 year-old anesthesiologist, now has Stage 4 leiomyosarcoma. No preoperative tests revealed the cancer lurking in her fibroids, but experts say if Dr. Reed had the fibroids cut out with a traditional operation, instead of laparoscopic morcellation, it is highly unlikely that the cancer would have spread.