Last year, leading gynecology experts sent an open letter to the U.S. Food and Drug Administration requesting that the agency rescind or revise a warning issued on a device used to perform laparoscopic procedures to remove uterine fibroids.
The FDA had concerns that laparoscopic power morcellators (LPM) used to remove uterine fibroids that are later discovered to be malignant may scatter fragments of cancer, leading to the spread of the disease.
However, 48 gynecologists, gynecologic oncologists, surgical oncologists, and women’s health advocates said that they believe the agencies decision, while well intentioned, was based on incorrect data.
William Parker, the lead author of an editorial written by the Leiomyoma Morcellation Study Group, had this to say about the data the FDA used when making the decision to issue the warning:
“The FDA’s estimate that 1 in every 458 women having surgery for presumed fibroids actually has LMS appears to overstate the risk.”
Parker went on to note that a recent analysis of 133 studies determined that the risk of finding a leiomyosarcoma was minimal. The risk of finding the cancer in a woman having surgery for presumed fibroids was actually 1,960 or 0.051 percent.
If you have been injured or experienced side effects due the use of a medical device or prescribed medication, you may be entitled to compensation. Contact the law offices of John Foy & Associates and let the “Strong Arm” attorneys fight for you. Contact us today.