In November, 2014,the FDA responded to articles published in The Wall Street Journal on the safety of the laparoscopic power morcellator. The articles emphasized risks connected to the device; therefore, the FDA cautioned physicians to refrain from using it on most women.
Morcellators have been used to remove fibroids within the uterus as well as used to perform hysterectomies for more than 20 years. The FDA found that woman having the fibroid surgery face a higher risk of uterine sarcoma than previously stated. The problem with the morcellator is fibroids are cut in segments and removed, which could cause a malignancy to spread.
America’s Health Insurance Plans called for the laws for approving and tracking in the Medical Device industry to become tougher. Using the risk factors connected to the laparoscopic power morcellator as an example of a flawed system in approval of such devices as well as how well they are observed once out in the field.
Three of the four largest insurers are either considering or have put limits on using the morcellator.
Although under fire, the FDA’s system for clearing a medical device, known as 510(k), has been called “overwhelmingly safe” by the president and chief executive of the Advanced Medical Technology Association Steve Ubl.
The American College of Obstetricians and Gynecologists has stated the device is an important tool. Many gynecologists believe the FDA over-reacted and they continue to use the morcellator but are asking patients to sign a consent form after being told the reported risks. Still others believe the device should not be used until further studies can prove them safe.
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