Laparoscopic Uterine Power Morcellator Lawsuit Help
In a Safety Communication dated November 24, 2014, the FDA cautioned that laparoscopic power morcellators should not be used on most women undergoing myomectomy or hysterectomy for treatment of fibroids, due to concerns that the procedure can spread cancer.
If you or a loved one has undergone one of these surgical procedures, and you have a question regarding your legal rights, please contact the Law Firm of Eric H. Weinberg for a free legal case evaluation at 1-877-934-6274.
What are Laparoscopic Power Morcellators?
Laparoscopic power morcellators are medical devices that may be used during procedures to treat uterine fibroids, including hysterectomy (removal of the uterus) and myomectomy (removal of the fibroids). The devices work by dividing or fragmenting the excised tissue into small pieces for removal through the small incision sites created during a laparoscopic surgery.
How serious is the problem?
The FDA estimates that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.* The agency also stated that at this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.
The FDA Urges Morcellator Manufacturers to Strengthen Product Warnings
The FDA urged manufacturers to include two new contraindications and a new boxed warning to laparoscopic power morcellator labeling.
The FDA recommended labeling contraindications warn that laparoscopic power morcellators should not be used in the following situations:
- Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision. (Note: These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
- Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
The FDA recommends that the following Boxed Warning should be added to power morcellator labeling:
“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.”
The FDA advised healthcare providers to be aware of these warning recommendations; and to carefully consider all available treatment options for women with uterine fibroids, and to discuss the benefits and risks of all treatment with patients.
Contact The Law Firm of Eric H. Weinberg for a Free Power Morcellator Lawsuit Evaluation
The Law Firm of Eric H. Weinberg is currently investigating claims on behalf of women who may have been injured as the result of power morcellator use during a hysterectomy or myomectomy. We are ready to help you. For a free, nonobligatory power morcellator lawsuit evaluation please submit the easy-to-use Lawsuit Evaluation Form found on this page, or call us toll free at 877-934-6274.
References
*http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm
