FDA Alert
FDA Response to Morcellator Problems
In April of 2014, the FDA made an unprecedented move to warn physicians and consumers against the ongoing use of power morcellator devices for the removal or uterine fibroids and/or hysterectomy procedures. The agency made this move after data revealed a serious risk of the spread of deadly forms of cancer when the morcellator was used to segment and suction the diseased tissue.
Essentially, their studies uncovered the fact that one in every 350 women who undergo a hysterectomy or a myomectomy (fibroid removal) also has an undiagnosed (often unsuspected) form of cancer. This cancer is Leiomyosarcoma (LMS), and it is treatable when it is local, but almost impossible to control once it has spread.
Unfortunately, the uncontained manner in which the morcellator segments the tissue allows cancer cells to enter the bloodstream and/or to be spread throughout the abdominal area. This allows the cancer to metastasize freely, and can turn a case of quite treatable LMS into what many call a “death sentence”. Because the data revealed such enormous threats to patient safety and health, the FDA issued the warning (a “safety communication”) that described the threat, and provided suggested steps for manufacturers, surgeons, and consumers to take.
The Suggestions and the Update
The suggestions included that the FDA discouraged the use of any morcellator gear for hysterectomy and/or myomectomy, that it should not be used at all in women suspected of having any sort of uterine cancer, that all treatment options be considered, and that the risks of the treatments be discussed with the patient.
Additionally, the FDA mentioned the use of a hysteroscopic morcellator, or one with a specimen bag system as a wiser option since it contained the tissue and minimized the threat of spread.
In November of 2014, the FDA released an update to its initial report and expressed ongoing concern around the use of the gear. The group clarified that it now warned, “Against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” (FDA.gov, 2014)
The statement also indicated that the FDA would like makers of the gear to include all of the newest findings on their product labels. Additionally, the FDA officially stated that the morcellators were contraindicated for removal of uterine tissue with fibroids (within the most likely age group), as well as being contraindicated for removal of tissue suspected of containing any malignancy.
The Firm Stance
In the updated statement in November, it was clear that the FDA was unlikely to budge from the original concerns. The second statement made it clear that the initial worries about the threat of the spread of LMS remained and that the organization had taken pains to uncover even more facts.
The FDA statements about morcellator problems have been addressed directly to consumers, health care providers, cancer advocacy organizations, hospitals and healthcare centers, and makers of the devices. This establishes it as a serious concern and validates the fact that a true threat exists.
While the use of laparoscopic procedures is tremendously beneficial to many of the patients who receive them, the statistics show that there is far too much risk for the spread of a deadly disease if a woman with fibroids allows herself to be operated on with a morcellator.
As minimally invasive as morcellators may be, by their very action they increase the threat of systemic cancer to a tremendous degree. And though most fibroids are non-cancerous, studies have shown that LMS tumors are more often discovered during operative removal than during the pre-operative state. With one in every 350 women at risk, the FDA response has been reasonable and responsible.
Source
FDA.gov. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. Nov. 2014. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm