The FDA has finally acted on the risk of cancer associated with laparoscopic power morcellators. For years, the FDA has known these morcellators can spread cancer, including leiomyosarcomas, throughout the abdomen and pelvis.
This is a good step towards protecting women from dangerous medical procedures.
The FDA is
- warning against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women;
- recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications.
“Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
The FDA estimates that about 1 in 350 women who undergo hysterectomy or myomectomy for fibroids have an unsuspected uterine sarcoma. The laparoscopic power morcellation grinds up tissue and spreads it throughout the abdominal area. If this tissue is cancerous, 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.
The Morcellator Boxed Warning
The FDA is requiring a new boxed warning for laparoscopic power morcellators. This type of warning alerts medical professionals to the severity of the complications associated with product use.
FDA is requiring the boxed warning to inform health care providers and patients that:
- Uterine tissue may contain unsuspected cancer.
- The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.
This information should be shared with patients when considering surgery with the use of these devices. If this information is not shared with a patient and the morcellator causes spreading cancer, the patient may have a medical malpractice claim. However, this is little consolation to the patient and her family.
Two Contraindications
In this case, a “contraindication” is a specific situation in which a procedure should not be used because it may be harmful to the patient. The FDA has issued 2 contraindications:
- Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: a) peri- or post-menopausal or b) candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision. Because these groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy, the morcellators should not be used for most of these surgeries.
- Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.
Other Options
There are other surgical treatment options available for women with symptomatic uterine fibroids, such as traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision (minilaparotomy).
It is critical that doctors discuss the risks and benefits of all options with their patients.
The FDA is continuing to review the many reports of cancer associated with the use of laparoscopic power morcellators and may take further action.
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