Power Morcellator Black Box Warning
2014-11-24 FDA News Release; Power Morcellator Warning
The FDA has issued an Immediately in Effect (IIE) guidance with the below boxed warning and contraindications for power morcellator surgical devices.
The boxed warning informs 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.
The two contraindications advise of the following:
- Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or minilaparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
- 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.
Legal Help for Women Harmed by Power Morcellators
Over the past decade, power morcellators have been widely used in both laparoscopic hysterectomy and fibroid removal procedures. Patients who have developed cancer due to these procedures are now filing product liability lawsuits claiming that the manufacturers of power morcellator devices were aware of the cancers risks and failed to warn patients and doctors. If you or a loved one have undergone a procedure where a power morcellator may have been used, and later developed cancer or abnormal fibroid growth in the abdominal area; you may be eligible for substantial compensation. For a free, no obligation legal consultation, please fill out the contact form on this page, call Arentz Law Group at 1-800-305-6000, or text 800-440-4400.
Find Out If You are Eligible for a Power Morcellator Product Liability Claim
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