FDA Reported Endometrial Ablation Complications Still Thought To Be Rare

Endometrial Ablation Complications Reported to the FDA in their Manufacturer and User Facility Data Base, as reported by Drs Brown and Blank in the journal Obstetrics and Gynecology, and serious complications are still thought to be rare. Prior to the advent of the minimally invasive devices like the NovaSure or the thermal balloon physicians performed these surgeries by manual laborious techniques and there were complications that we do not see any longer with the newest devices. These physicians evaluated over 800 reported complications of endometrial ablation in 9 categories of use in the years from 2005 to 2011. This type data is kept on all medical devices. The reports are obtained in a variety of ways, hospitals and licensed facilities are required to report any device related deaths or serious injuries, but it’s been noted that these events are under reported. In addition to a hospital or manufacturer reporting difficult cases both physicians and patients can all report complications to this data base. There are 5 approved devices for endometrial ablations which spare the uterus and yet treat heavy menstrual bleeding. This type of procedure has been preformed for over thirty years but these specially designed devices, which allowed the average gynecologist to perform the procedure, have been around for about 15 years. Except for hydrothermal ablation the procedures are performed blindly and the authors state that thermal injury in non target tissues, such as the bowel and the bladder, is the biggest worry. The report also found use outside the FDA guidelines is common. The most common and treatments like a second procedure, for when the first fails, is an example of how not every patient has been treated within the approved guidelines. Out of 829 reports of problems to this database over those years, Radiofrequency Ablation (like NovaSure) was responsible for 227 injuries, the Hydro ThermAblator for 545 injuries, interestingly the Cryoablation device had only 3 injuries and the Thermachoice balloon had only 16 device related complications. Bowel injuries, which are serious, was least likely with the Cryoablation device. Complications included infections, bowel injury, injury to the uterine wall (not just the lining tissue as intended). For the Hydro ThermAblator genital tissues or skin burns were the most common complication, and accounted for 529 of the 829 complications reported. The design of the Hydro ThermAblator was in part to blame for the heat issues and in 2009 the design of the device was improved after a device recall, but the injuries occur annually even still. Since we do not have data that reports the overall case numbers, the rate of these problems is not able to be calculated exactly, but based on some of the reports, this is a very small percent of all the cases done, and it is important to note that the complications may be operator dependent. About 8% of all injuries reported were associated with use of the device beyond the manufacturers recommendations for use. Hematometra, responsible for most of the post endometrial ablation cases only occured in about 1% of cases. Physicians have the ability to use a device in an individual case, but performing the surgery within manufacturer's guidelines is likely to create greater safety, and before you have a repeat procedure discuss options for your care with your gyno.




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