BBI Contributing Writer

In August 1999, BBI reported on endometrial ablation as an alternative to hysterectomy in order to eliminate dysfunctional uterine bleeding (DUB). Since then, several companies have submitted PMAs for devices that perform endometrial ablation and are now waiting to hear back from the FDA.

Dysfunctional uterine bleeding is excessive menstrual bleeding (menorrhagia) with no associated medical condition or cause. DUB can cause anemia, fatigue and greatly impacts the normal lifestyle of the woman affected. It affects 10 million women in the U.S. annually and until Gynecare's (Newark, New Jersey) approval of the first endometrial ablation device, hysterectomy was the most prevalent treatment for it. In fact, of the 550,000 hysterectomies performed annually in the U.S., about 25% of those were performed to eliminate dysfunctional uterine bleeding. Many feel that an effective endometrial ablation program is critical for a viable practice.

There are many approaches to treat DUB, often starting with hormone drug therapy, dilation and curettage (D&C) and transcervical resection of the endometrium (TCRE). None of these approaches have demonstrated good long-term results or eliminated a trip to the operating room. Although TCRE is less invasive than a hysterectomy and leaves the uterus intact, the procedure still requires a specially trained gynecologist, general anesthesia and an OR setting. The market demand is for an office-based, simple procedure that can conserve the uterus (Table 5 on page 92 and Table 6).

In 1997, Gynecare, a division of Johnson & Johnson (New Brunswick, New Jersey), received the first PMA for an endometrial ablation device for its Thermachoice. Market acceptance of the product was immediate, with 650 units installed in U.S. sites by the end of 1998 and annual sales reported to be in the $30 million to $35 million range. Since then, at least three other companies – Cryogen (San Diego, California), BEI Medical (Teterboro, New Jersey) and Novacept (Palo Alto, California) – have been vying for the next approval to gain entry into this marketplace, with others behind them.

Each device uses a selected form of energy such as heat (Gynecare and BEI), RF energy (Novacept) or freezing (Cryogen) to ablate the uterine lining. In theory, devices that use a balloon may miss some nooks and crannies of the uterus. On the other hand, with free circulating hot saline it is possible to get cervical burns since the fluid is not contained within a balloon. With cryotherapy, it is difficult to control or measure the depth of freeze, but the ice ball is visible upon ultrasound. While RF energy is controllable, it does not provide visualization. Although clinical studies on all these forms of energy – as well as others – are under way, it is still uncertain as to which one of these approaches will produce a better outcome.

Next approvals

Industry sources predicted that Cryogen would obtain the next approval; however, at the panel meeting held in February, the FDA granted Cryogen a conditional approval dependent on the company making some product changes and performing additional studies. In fact, it appeared to those present at the panel meeting that the FDA may have been signaling potential guidelines for future panel meetings. Those criteria being:

1) Demonstration of consistent treatment protocol among all patients/surgeons.

2) Consistent safety and efficacy results from all centers in study.

3) Acceptable device malfunction rate (under 10%).

Cryogen also was asked to include in its product labeling that ultrasound guidance, conducted by a trained ultrasonographer, be used on all cases. It may be that the FDA is establishing a visualization criteria or some safety mechanism be present in every device.

With Cryogen now having to obtain additional information, it puts BEI Medical and then Novacept next in line for PMA acceptance. And approximately two years behind them are several other anxious entrants, including Microsulis (Waterlooville, United Kingdom) and ESC Sharplan (Norwood, Massachusetts), both of which have clinical trials going on in the U.S. on products that already are on the market in Europe.

New niche

A new niche that seems to have arisen from this market is one of lifestyle change. It was discovered during the clinicals that many of the women had no periods (amenorrhea) following the endometrial ablation procedure and appreciated that additional benefit. Some of the companies have found that this may be an additional market niche, especially for those women who have completed their families, have not yet reached menopause, and would prefer not to have a monthly period. Although no company has approached the FDA for this claim, it could attract patients who would otherwise be on the fence for having an endometrial ablation procedure, thus driving the market numbers higher.