Warnings on Morcellation Procedures
Morcellator Usage Expanding to Treat More and More Women
Every year, hundreds of thousands of women are diagnosed with some form of uterine cancer, fibroids, or other problem affecting their reproductive system. After speaking with their medical provider, nearly 60,000 women decide to have a hysterectomy performed to remove part or all of their entire uterus and possibly even their cervix, fallopian tubes, or ovaries.
One procedure that is commonly recommended to address these problems is laparoscopic morcellation. This method employs a thin, hallow, tube-like structure to puncture, mince, and remove the affected area of the body. While its physical makeup allows it to extract the section with minimal invasiveness, it does also add significant complications such as the possibility of the spread of cancer already existing in patients.
FDA Renews Warnings Against Morcellator Usage
In April of 2014, the U.S. Food and Drug Administration published a specific warning against the use of laparoscopic morcellation as a method of performing hysterectomies and myomectomies (the removal of fibroids found in the reproductive system). The full text can be read here: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm.
Specifically, it outlined the possibility that this operation could spread uterine cancer already existing in a small number of patients undergoing morcellation (approximately 1 out of 350 women). It went on to extend several warning to health care providers and women. To the former, it cautioned against recommending this procedure without considerable review and attention.
Further, it advised doctors to strongly disclose the potential risks of laparoscopic morcellation to each and every patient before the start of surgery. To the latter, it encouraged all women to study the advantages and disadvantages of every potential course of treatment. Additionally, it reminded them to continue treatment with their doctors after this surgery to monitor the presence or spread of cancerous cells.
In November of 2014, the FDA updated its warning and also took several actions on its own after research continued to link laparoscopic morcellation to the spread of uterine cancer, including the following:
- Issued a new warning for the use of laparoscopic morcellation, which reads as follows: “The FDA warns 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.”
- Published an internal report spanning thirty years of review. It estimates the prevalence of uterine sarcoma and leiomyosarcoma in patients undergoing hysterectomies and myomectomies as 1 in 352 and 1 in every 498, respectively.
- Urged manufacturers of morcellators to include information on their product labels regarding the possibility of the spread of existing cancerous cells following laparoscopic morcellation.
- Published content via its website regarding the safety implications of using morcellators in surgery as well as the possible alternative available to patients considering hysterectomies and myomectomies.
The full text can be read here:
Interestingly, despite a lengthy and vigorous debate on the relationship between uterine cancer and laparoscopic morcellation in the medical community, the FDA, as of yet, has not issued a recall complete full ban on its use in surgery.
Opinion of the Medical Community on Laparoscopic Morcellators
Since their recent arrival onto the medical stage, laparoscopic morcellators have become extraordinarily popular due in large part to their lack of intrusiveness. As noted above, this device is chosen thousands of times every year in the operation of hysterectomies and myomectomies. After questions arose recently regarding its use in patients with preexisting cancerous cells, doctors across the country have largely fallen silent and waited for direction from the government and other medical authorities.
After the FDA issued its latest warning regarding the use of morcellators, the American College of Obstetricians and Gynecologists issued a non-sequitor statement applauding the government for trying to protect patients from the possible spread of cancer and other harms. The full text can be read here: http://www.acog.org/About-ACOG/News-Room/Statements-and-Advisories/2014/ACOG-Statement-on-Power-Morcellation.
The lack of firm direction and action across the medical landscape might be attributable to the absence of new information linking morcellators to the spread of cancer. On the other hand, it might also stem from the lack of direction from the government, either of which might spur doctors to completely halt the use of these seemingly dangerous instruments.
For additional information on litigation related to power morcellators view our page here.