The FDA speaks out
Earlier this month, the U.S. Food and Drug Administration issued a memorandum that discouraged surgeons from using a common procedure called power morcellation to remove uterine fibroids. Power morcellation uses a medical device to divide uterine fibroids into smaller pieces that can be removed through a small incision in the abdomen, such as during laparoscopic surgery.
Why was the FDA announcement necessary?
New data from the Center for Devices and Radiological Health show that power morcellation can spread undetected cancers more often than previously realized. According to the data, one in 350 women who undergo a hysterectomy to treat fibroids or who have fibroids removed have undiagnosed uterine sarcoma — a type of cancer that can be aggressive. If power morcellation is performed in women with this kind of uterine cancer, the procedure can spread the cancer around the abdomen and pelvis.
The agency’s review occurred following wide media coverage of Dr. Amy Reed, a 41-year-old Boston anesthesiologist who underwent a power morcellation hysterectomy in October 2013 to treat what she was told were likely benign uterine fibroids. Follow-up tests found that Reed had uterine leiomyosarcoma, a very aggressive tumor. Imaging tests showed that the cancerous tissue had been spread throughout her abdominal cavity, giving her stage 4 cancer.
The FDA stopped short of ordering the devices needed for this procedure off the market because, according to a spokesperson, “there still may be individual patients who benefit from the procedure.”
Uterine fibroids: A bit of background information
Most women will develop uterine fibroids at some point in their lives. Most uterine fibroids do not cause problems. However, uterine fibroids can cause unpleasant or even painful symptoms, such as:
• heavy or prolonged menstrual bleeding,
• pelvic pressure or pain, and
• frequent urination
Between 500,000 and 600,000 women undergo hysterectomies in the United States every year. Up to 40 percent of these procedures are to treat painful fibroids.
What do I think?
I’ve had concerns about power morcellation for some time: I think it’s an expensive and dangerous technique that does not improve surgical outcome. While I’m in full support of the FDA’s safety advisory, I think they should have gone even further and taken the devices off the market until a solution is found. Fortunately, there are some good alternatives to power morcellation, including a small lower abdominal incision, manual extraction though a laparoscopy incision, and manual morcellation via posterior colpotomy (an incision in the back of the vagina). I believe that posterior colpotomy is the best option in many cases because it is safe and associated with minimal postoperative pain and excellent cosmetic outcomes.
If you’re considering treatment for uterine fibroids, be sure to discuss with your physician all the available treatment options, including the benefits and risks. If you’re in the area, give me a call to set up an appointment.
Additional information on uterine fibroids
Extensive information on uterine fibroids can be found at:
FDA Safety Communication: Laparoscopic Uterine Morcellation, April 2014
National Institutes of Health: Uterine Fibroids Fact Sheet, March 2013
John M. Garofalo, M.D.: Uterine Fibroids
About the practice
Dr. John Garofalo, M.D., is a gynecologist located in Fairfield County, Connecticut. He has more than 20 years of practice and surgical experience covering many facets of obstetrics and gynecology.
Laury Berwitt is a nurse practitioner specializing in women’s health in Fairfield County, Connecticut. Laury has a passion for providing quality women’s health care in a safe and comfortable manner by creating a trusting patient-practitioner relationship. She has been in practice for 10 years, caring for women of all ages.
For more information, go to www.garofaloobyn.com. John Garofalo, MD and Laury Berkwitt, APRN can be reached for personal consultations by calling 203.803.1098.