Last Friday 12 members of the US Congress sent a request to the US Government Accountability Office (GAO) asking them to investigate the FDA’s monitoring of a potentially dangerous gynecological device. The laparoscopic power morcellator, has been in use since 1993. The tissue dissecting tool has been linked to the spread of cancerous cells in hysterectomy or uterine fibroid removal surgeries.
The letter from Congress stated that, “Hundreds, if not thousands of women in American are dead because of a medical device known as the laparoscopic power morcellator.” The members of Congress are concerned as to why the power morcellator was widely used for 20 years before the FDA issued safety warnings about the possible hidden cancer risk.
When the FDA first approved the device in 1993, they concluded that the risk was small with only about 1 in 10,000 women having the hidden cancer cells that might be spread. In late 2013, after reviewing their findings, the FDA updated the risk to up to 1 in 350 women having a hysterectomy might have an undetected cancer.
In 2014, the FDA warned against the use of power morcellators to remove uterine fibroids could spread uterine sarcoma cells. Before the warning, it is estimated that the device was used in as many as 50,000 uterine surgeries per year. Later that year, in November, the FDA increased the warning by recommending against the use of morcellation in hysterectomies.
The letter by Congress is calling into question the FDA’s approval process which allowed this potentially deadly medical device to be on the market for decades. It is hoped that this missive will lead to improvements in the FDA system and protect the health of the American people.