FDA to Revisit Safety of Essure

Essure is the only nonsurgical permanent birth control option approved by the FDA. And thousands of women are wondering why it’s still on the market.

Many women who have undergone the procedure to implant Essure have had it removed after experiencing a range of side effects, including chronic fatigue, migraines, joint pain, digestive issues, back pain, heavy periods full of clots, difficulty concentrating, abdominal pain, hair loss, tooth deterioration, depression and severe bloating.

Amanda Dykeman, 33, was one of those women. In a story by NPR, she said, “Physically, it has permanently ruined my body inside and out.”

Approved by the FDA in 2002 for women ages 21 to 45, Essure is a soft, flexible metal spring made from a nickel-titanium alloy. An obstetrician/gynecologist inserts one coil into each of a woman’s fallopian tubes. As scar tissue grows around the foreign body, it blocks the tubes and prevents eggs from entering the uterus and becoming fertilized. The principle is the same as an IUD, but it’s placed higher up the reproductive organs.

Women who have had Essure implanted must return three months later for a follow-up X-ray using dye to confirm that the tubes are fully blocked, at which point it’s considered 99.83% effective against conception.

Dykeman participated in a Facebook group of more than 18,000 women who have experienced problems with Essure. Although it’s supposed to be permanent, many of the women, like Dykeman, have had it removed and don’t understand why their doctors, the FDA and Bayer, the manufacturer of the device, for years have dismissed their concerns.

Bayer noted the product passed a detailed analysis by the FDA before it was put on the market. “Essure was reviewed through the premarket approval process for Class III medical devices, the most stringent type of device marketing application, according to the FDA,” a spokeswoman for Bayer told NPR.

Bayer said approximately 750,000 women have been implanted with the device.

But as of this summer, the FDA finally seems to be hearing the complaints. It updated the short- and long-term risks listed on its website as affiliated with Essure, as well as adverse events reported through May.

Patients and doctors can report problems that occur after implantation of a medical device to the FDA’s Manufacturer and User Facility Device Experience database (MAUDE), but the device surveillance system is passive, NPR explained. That means anyone can report anything that happens, whether it’s related to the device or not. Some problems might be reported several times, and others not at all.

Since Essure’s approval, the FDA has received more than 5,000 reports of medical problems linked to it, primarily abdominal pain, headaches, fatigue and weight fluctuations. More than 400 accounts by patients or doctors have reported that Essure coils migrated from the fallopian tubes to other parts of the reproductive system, and five reported fetal deaths after Essure failed to prevent pregnancy. But it’s unknown how many of those 5,000 reports are duplicates, and how many are problems caused by Essure.

The FDA has scheduled a public advisory meeting of its Obstetrics and Gynecology Devices Panel for September that will include experts, physicians and patient and industry advocates to review the data and hear public comments from women.

Among measures it might consider are whether Bayer must amend labeling, whether Essure should be removed from the market and whether additional studies are required about its risks and benefits.

For a clear risk/benefit picture of Essure, any problems associated with the device would have to be compared against the risks of laparoscopy, pregnancy and other forms of birth control. (Laparoscopy is minimally invasive surgery in which a fiber-optic instrument is inserted through the abdominal wall to view the organs in the abdomen or to permit a surgical procedure.)

It’s unclear now if Essure actually causes many of the problems women report, and how common they are.

Dr. Elizabeth Micks, an Ob-Gyn and contraception specialist at the University of Washington Medical Center in Seattle, said women often voice complaints they attribute to their method of birth control, even if that method cannot feasibly cause some of them.

“Some are valid, and some may not be valid, and it’s hard to really know in some cases whether the method is causing the patient’s complaints,” Micks said. “I think it is very clear that some women have been harmed by the Essure device. Whether that means it should not be an approved method isn’t clear.”

Based on the data from the clinical trials conducted before Essure was available to consumers, about 9 in 100 women experience mild to moderate pain during the procedure, and 13 in 100 experience it immediately afterward. Other known effects immediately after the procedure include cramping, vaginal bleeding, nausea, vomiting, fainting and pelvic or back pain for several days. Rarely, the body can expel a coil.

Long-term risks, according to the data, include rare cases of chronic pelvic pain; allergic reactions to the nickel; a coil that perforates the fallopian tube or uterus; or cases in which the coil migrates through the tubes, requiring surgery. Women with Essure also have a higher risk of ectopic pregnancies (conception occurs not in the uterus, but outside, usually in the fallopian tube).

Bayer reported that five years after the device went on the market there were no significant new safety concerns, such as extreme fatigue, depression or weight gain, or an increase in known ones.

But that’s insufficient, Dykeman and her fellows on social media say, because most research to date has been funded by Bayer or by Conceptus Inc., the company that developed the device and was then acquired by Bayer.

Micks wants more data on long-term complications. The longest study currently available is a 10-year retrospective study, which mostly analyzed pregnancies and contraceptive effectiveness.

“Most of the data we have are from the clinical trials, and you can’t necessarily go by the clinical trial data in looking at complications because obviously some women in real life practice aren’t following up,” Micks said, “so we don’t really know if they have a malposition of their coils. … I feel like the terrible cases I’ve seen are really people who were not properly informed about the risks and benefits ahead of time. I think the bigger problem is what physicians are communicating with patients.”

Dykeman probably would find that … disingenuous. Her pain and symptoms prompted her to request a hysterectomy nearly three years after she got Essure. Her surgical report noted chronic inflammation of the cervix, several attached blood clots and a photo showing a coil outside her left fallopian tube.

Her symptoms improved after the surgery, but they’re not gone. “I was recently told my entire abdomen is full of adhesions that attach my organs together with bands of scar tissue, making it hard for my food to digest,” she said.

Micks has observed complications from Essure she attributed to physicians not following standard clinical practice for its use. For example, one woman’s follow-up X-ray showed improper placement of the coils and the patient did not receive the proper procedure to remedy it – laparoscopic surgery. Instead, she became pregnant, underwent the Essure procedure a second time and later was found to have three coils perforating the uterus on one side.

What in the world was that practitioner thinking?

“Essure is not perfect, but no method is,” Dr. Jeffrey Jensen told NPR. He’s director of the Women’s Health Research Unit of the Center for Women’s Health at Oregon Health and Science University in Portland. “It is an important option that should be available to women as an alternative to general anesthesia and laparoscopy.”

He hopes the FDA will allow Essure to remain on the market, but whatever the agency decides, it should be based on data, not case reports, he said.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information