NovaSure and Other Endometrial Ablation Procedures Linked To Reports of Burns, Other Serious Injuries

A growing number of women indicate they have experienced problems from endometrial ablation procedures involving Novasure and similar devices, which are designed to decrease menstrual bleeding, but have been linked to reports of severe internal burns, the need for hysterectomies, and even some deaths.

A report published last week by MedPage Today indicates that the FDA has received hundreds of adverse event reports involving endometrial ablation complications over the last decade. In addition, the report found Facebook groups that include thousands of complaints by women who suffered endometrial ablation injuries, including petitions that call for NovaSure class action lawsuits and claims against other medical device manufacturers.

Endometrial ablation devices are used to theoretically decrease menstrual bleeding by inserting a device through the cervix into the uterus, which then uses radiofrequency (RF) energy to burn away the endometrial lining. If that lining is gone, there is significantly less bleeding during menstruation.

The most well-known of the devices is the NovaSure by Hologic, but there is also the Minerva, the Minitouch, Genesys HTA, Thermablate and Her Option. Another similar device, Johnson & Johnson’s ThermaChoice, has already been removed from the market.

The first NovaSure device hit the market nearly 20 years ago, and Hologic estimates the one device has been involved in about three million procedures.

The devices and procedure have been linked to a condition known as endometrial ablation failure, which is linked to a variety of complications which frequently require the woman to undergo a hysterectomy to resolve, leaving her infertile.

MedPage’s review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database over the last 11 years revealed 1,815 adverse event reports. The most common reported complication was perforations, with 519 reports. That was followed by 222 reports of hysterectomies, 213 reports of infections, 185 reports of burns, and 141 reports of the need for bowel surgery.

In addition, there were reports of sepsis, cardiac arrest or bradycardia, and at least six reports of deaths. Many of the injuries are often classified in the broad category known as thermal bowel injuries.

The number of women who have experienced problems and decided to speak out has been growing over the last several years. One Facebook support group has more than 5,000 members, and there is a petition for a class action lawsuit with 1,700 signatures.

Women often indicate they were advised to try the procedure by the obstetrician/gynecologist but were not fully aware of the risks.

Hologic representatives told MedPage Today that all of the potential adverse events, including the risk of death, are listed in the Instructions For Use. The company says its estimates are that thermal bowel injuries occured in less than 1 in 10,000 cases.