The FDA first issued a warning about the use of power morcellators in hysterectomy and myomectomy procedures in April 2014 and then expanded and clarified it in Sept 2014.
Since that time there have been growing voices of disquiet against the devices, with the first lawsuits being filed in Pennsylvania in March 2014, and up to two dozen cases pending in federal court as of July 2015, according to Trial Magazine.
It is worthwhile to re-visit the two original FDA warnings to see how the scope expanded even in just the six months between the two dates when they were issued, to get a flavor for how this issue is likely to mushroom over the coming years.
The first key difference is in the audiences to which the warnings were targeted. The original April 2014 update targeted the following medical specialties: Internal Medicine, Pathology, Obstetrics/Gynecology, Nursing and Oncology. While the September warning added in Obstetrics/Gynecological Surgery and also, crucially, General Surgery into the mix.
General Surgery is a specialty that focuses on the content of the abdomen, including the liver, stomach, pancreas, esophagus, small bladder, bile ducts and gall bladder. As well as some diseases of soft tissue, breast and skin. In effect then it covers a massive amount of medical ground. According to CDC statistics, for example, there were 6,027,000 operations carried out on the digestive system in 2010, which is over 12 times the number of hysterectomies. So its inclusion on the September 2014 FDA warning would seem to indicate that the FDA is anticipating the issue of the safety of power morcellators to spread much more widely than they had originally anticipated.
This ‘upgrading’ of the potential risk is also evident when you compare the stated ‘purpose’ of the two warnings.
In April 2014 the FDA had the statement as:
“Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
But by September 2014, this had been upgraded to:
“The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids.” (My highlights)
The scope of the problem has clearly been considerably expanded in the eyes of the FDA, despite the fact that the original figures of 1 in 350 women undergoing those two procedures being affected has remained unchanged.
This concern though is understandable, given that both of these procedures are very common, with around half a million hysterectomies performed every year in the United States, of which 11% are said to have been performed with the help of a power morcellator. So even a very low statistical number of problems, can equate to potentially thousands of women being adversely affected in the real world.
The September warning also added in two new contraindications that hadn’t been mentioned in April. As well as a new box warning for the devices to say that uterine tissue could contain unsuspected cancer.
More recently, in August 2015, 12 members of Congress sent a letter to the Comptroller General of the United States, Gene Dodaro, requesting further investigation. They opened up their letter with this line:
“Hundreds, if not thousands, of women in America are dead because of a medical device known as a laparoscopic power morcellator.”
We have not heard the last of this issue.