April 30th, 2014|
UPDATE 4/30/14 4:34 p.m.: Johnson & Johnson pulls its morcellators off of the market and several hospitals have announced they will not use the devices pending further investigation.
The FDA has issued a Safety Communication regarding cancer risk and the use of a medical device used during some laparoscopic surgeries for fibroid tumors.
The device, called the power morcellator, can be used during minimally invasive hysterectomy and myomectomy. These two procedures are frequently performed to treat uterine fibroids (leiomyomas).
Minimally invasive hysterectomy can include the use of a laparoscope and/or a robot. On rare occasions, the uterine fibroid may be cancerous. If a power morcellator is used and cancer is present, this could spread the cancer cells to other areas of the abdomen. According to the FDA, spreading the cancerous tissue would significantly worsen the patient’s likelihood of long-term survival.
On April 17, 2014, the FDA sent a Safety Communication to health care providers.
The Safety Communication included the following:
Recommendations for Health Care Providers:
- Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.
- Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.
- Carefully consider all the available treatment options for women with symptomatic uterine fibroids.
- Thoroughly discuss the benefits and risks of all treatments with patients.
- For individual patients for whom, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option:
- Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
Be aware that some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis