Jun 11, 2015

Posted by in Hospital Risks, Personal Injury | 0 Comments

History of the FDA and Power Morcellators

The Food and Drug Administration (FDA) is typically prominent when it comes to dangerous drugs, medical devices, and consumer products. It is, after all, the regulatory body that approves the introduction of these products to the general public. This includes medical devices such as power morcellators, that it cleared for medical use for the first time in 1991. In that particular instance, events unfolded that prompted the FDA to stand and take notice.

More than two decades after giving it the go-ahead, the FDA has issued a succession of safety communications to the public regarding the dangers of laparoscopic power morcellators for hysterectomies and myomectomies. By this time, the instrument had become commonly used, and thousands of women exposed.

The first warning came in April 2014, which discouraged doctors from recommending morcellation for these routine procedures, and manufacturers from marketing it. The data they analyzed indicated that one out of 350 women on which the morcellators are used develop uterine sarcoma. It is speculated that it resulted from cutting up unsuspected sarcomatous (cancerous) uterine fibroids. Immediately following this warning, Johnson & Johnson stopped sales of its laparoscopic power morcellators.

In July 2014, the FDA consulted with the Obstetrics and Gynecology Devices Panel to determine the at-risk populations with the use of morcellators. The discussion also revolved around how to mitigate these risks.

An Immediate in Effect second warning was released on November 24, 2014, and this time included recommended labeling guidelines for boxed warnings and safety statements on contraindications. The boxed warning specifically stated that unsuspected cancer cells may be lurking in uterine tissue, and that open morcellation can speed up its spread. Specifically, it should not be used for the removal of uterine fibroids in post- or peri-menopausal patients, or any gynecological procedure where cancer is suspected.

According to a website about morcellator lawsuits, however, the manufacturers should have known about these dangers much earlier in the day. The FDA warnings came out much too late for thousands of women that have succumbed or currently suffering the consequences of this oversight. If they had known the risks they were taking, they would probably have elected for a different way of getting the surgery done.

If you acquired uterine sarcoma or other complication linked to power morcellators, you may be a candidate for a dangerous product lawsuit. Consult with a morcellator lawyer in your area and find out more.

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