On Monday, November 24, the FDA released a warning against the use of laparoscopic power morcellators in both hysterectomy and myomectomy surgeries. The warning came after findings showed that the use of power morcellators in such procedures carried an increased risk to women with uterine fibroids. The warning came as an Immediately in Effect (IIE) guidance, where the FDA also called on manufacturers to include a "black box" warning on their product labels, as well as two separate contraindications.
The boxed warning would warn healthcare providers and patients alike that there is a chance that uterine tissue may contain undetected cancerous cells. In fact, the FDA has stated that 1 in 350 women who have a laparoscopic hysterectomy or myomectomy may have an undetected sarcoma. If power morcellation is used during the surgery, the cancerous cells may spread aggressively throughout the rest of the body.
The two contraindications recommended by the FDA are that power morcellators should not be used:
To remove uterine tissue containing potential fibroids if patients are either:
- Peri- or Post-Menopausal
- Candidates for En Bloc Tissue Removal
- In gynecologic surgery where the tissue is either known or suspected to be cancerous
While the FDA has issued the strongest warning for this surgical tool, critics are stating that it falls short of a complete ban, which would better protect consumers from this dangerous device. As one opponent of the morcellator said, "I think the wording is such that no sound practitioner would use it, but there are still people who won't know who will be at the mercy of their physicians." The American College of Obstetricians and Gynecologists has since stated that they are pleased by the decision; however, they are seeking to obtain further clarification on the use of power morcellators on women who are eligible for the procedure.
For example, some gynecologists have stated that the IIE guidance from the FDA would not likely have any effect on the way that they currently practice as they routinely work with women who are younger and therefore more prime candidates for use of the morcellator. Critics, however, point out that doctors would be taking a gamble with their patients—even with young women who have a comparatively lower risk.
If you or someone you love has been diagnosed with cancer after having a surgery performed with the use of morcellation, do not hesitate to get the help you need from an experienced medical injury lawyer.