Ever since your doctor recommended that you have one, you’ve been researching hysterectomies. You’ve been suffering from fibroid pain for over a year, and you’re not sure how much longer you can take it. When your doctor suggested a hysterectomy, although you thought it may be a little extreme, you were hopeful about being pain-free. However, after several months of research and discussions with your family, you’re not quite sure.
You discussed the risks of evasive surgery with your doctor. After a horrifying 30 minutes, he explained that it could also be done non-invasively with the use of a common tool called a morcellator. After being reassured of how easy the procedure was with that tool, you scheduled the hysterectomy and left that appointment feeling a little more confident with your decision.
Then you Googled morcellators—the result wasn’t good.
You read an article where the Food and Drug Administration (FDA) warned about the use of morcellators in hysterectomy procedures, and felt sick. Your doctor just told you that they were perfectly safe, and the only thing you had to worry about was a tiny scar. Now you learn that the FDA has warned the public about them.
What else don’t you know? What should you know? How is the FDA handling the concern?
FDA Recommendations for Enhancing Understanding and Device Safety
According to the Mayo Clinic 75 percent of women will develop uterine fibroids at some point in their lives. For some, these fibroids are not symptomatic and go unnoticed. However, for the unlucky, these fibroids can be excruciatingly painful and require hysterectomies to successfully alleviate the pain. The Centers for Disease Control and Prevention estimates that nearly 400,000 women a year undergo hysterectomies as a result of fibroids. Unfortunately, for these women, this is what the FDA is concerned about.
According to a recent FDA report, women undergoing laparoscopic power morcellation for the treatment of fibroids are at risk for the spread of cancer cells. Since the morcellator essentially grinds tissue, it could inadvertently disperse cancer cells into the abdomen or pelvic region, causing them to spread more rapidly.
In an effort to enhance understanding of this concern, and provide information on the appropriate use of morcellators, the FDA is taking the following steps:
- Demanding manufacturers include warning labels. Manufacturers of power morcellators specifically used during laparoscopic hysterectomy and myomectomy are to review their product labels and make sure that accurate risk information—for patients and providers—are included in packaging.
- Increasing awareness. A public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee will convene on the FDA’s recommendation to discuss the clinical role of laparoscopic power morcellation, options for enhancing the safety and effectiveness of these devices, and whether or not a “boxed warning” related to the risk of cancer spread should be required for laparoscopic power morcellators.
- Increasing research and studies into the problem. Adverse event reports, peer-reviewed scientific literature, information from patients, health care providers, gynecologic and surgical professional societies, and medical device manufacturers will be continuously reviewed and investigated.
Although the FDA has taken an interest into morcellator safety, the devices are still being used without proper risk management and precautions by medical professionals. If you believe that you have suffered adverse effects from a power morcellator being used during your hysterectomy, you deserve to know your legal rights. Call us today for a free consultation and review of your case. If the FDA recognized flaw with the tool has caused you harm—you deserve compensation, and we may be able to help you get it. Let us help you get the justice you deserve, while also helping others get the information they deserve to know about this device.
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