April 17, 2014
The FDA has saved lives today by announcing that they discourage surgeons using an FDA-approved device called a power morcellation device to remove the uterus or uterine fibroids.
This announcement is the result of excellent media coverage explaining that when uterine fibroids contain undiagnosed cancer, the use of power morcellation during laproscopic surgery can spread the cancer. The result is that a small contained cancer can spread and become a stage 4, fatal cancer.
This example indicates several major flaws in the system intended to protect patients from unsafe medical products and procedures:
- FDA standards for approving medical devices is much too low, resulting in unsafe devices such as the power morcellation.
- While many patients have been irreparably harmed by power morcellation devices that spread their undiagnosed cancer, surgeons and other health professionals rarely reported when that happened. The voluntary system of reporting serious medical harm from devices, including deaths, is not working because most physicians are not reporting most incidents, regardless of how serious they are.
- The FDA apparently hardly noticed the problems with power morcellation until two Boston physicians, Amy J. Reed and her husband, Dr. Hooman Noorchashm, became outspoken advocates against it in the media. Dr. Reed was diagnosed with a rare uterine cancer as a result of morcellation of what was thought to be a benign fibroid, and she and her husband have used their medical connections and the media to try to prevent that from happening to any other women. We thank them for their courage in speaking out and our prayers are with them.
The FDA needs to do more to prevent these and similar tragedies due to inadequately tested medical products that too often are used by physicians who are inadequately trained to use them safely. And patients need to be better informed of the risks of medical procedures, not just of the possible benefits.
To read a recent medical journal article on power morcellation, see http://jama.jamanetwork.com/