Jenna Vanderhoof and Archell Banta both decided two children were enough, and each opted for a permanent, irreversible birth control procedure via a device called Essure.
That’s where the stories of the Albany women began to diverge.
Vanderhoof is part of the vast majority of patients for whom Essure, a set of metal and polymer coils quickly and easily implanted in the fallopian tubes, works brilliantly.
Basically, she doesn’t even know the coils, put in place three years ago, are there — and she hasn’t gotten pregnant.
“The procedure was very simple, considering what it’s doing, and it hasn’t changed anything about my normal body function,” Vanderhoof says.
Banta, however, is among the roughly 1 percent of patients who blame debilitating conditions on the device, which she had implanted in March 2013.
The troubles reported by her and others — there’s a Facebook page called Essure Problems, and consumer activist Erin Brockovich maintains a website, essureprocedure.net — include back, joint and pelvic pain, bleeding, extreme lethargy, headaches, menstrual irregularities and weight fluctuation.
Banta says her gynecologist didn’t think severe discomfort and fatigue, and generally feeling awful, were related to the Essure coils.
But Banta switched doctors — she declined to provide their names for the record — and two months ago underwent a second procedure: the surgical removal of her fallopian tubes, uterus and cervix.
Her case illustrates the point that while Essure proves safe, effective and trouble free for nearly everyone who chooses it, if you’re unlucky enough to fall outside that “nearly everyone” category, the results can be spectacularly bad. That’s the message Banta wants to get across.
A 12-year history
Essure has been available since 2002. The device’s manufacturer, Conceptus, was purchased by Bayer Healthcare in June 2013.
After the coils, made from the same materials used in heart stents, are implanted in a woman’s fallopian tubes, scar tissue forms around them. The scarring creates tubal blockage that performs the same function as a tubal ligation (tube tying) operation.
Unlike tubal ligation surgery, which requires general anaesthesia and must be done in a hospital or surgical center, the Essure procedure is done in a doctor’s office.
“It’s a safe procedure,” said Albany gynecologist Paul Daskalos, who performed the implant on Vanderhoof. “It requires essentially no anaesthesia, it’s incision free, and it’s hormone free.
“I’m an advocate of the procedure, but it has to be individualized, and not everybody is a good candidate. But if you’re looking at permanent sterilization options for women, this procedure has many advantages. It’s well tolerated, and there’s essentially no recovery; they can go back to work later the same day.”
Over the past 31/2 years, Daskalos has performed the Essure procedure about 50 times. It’s been verified as successful — by an X-ray exam at three months to make sure the coils are positioned properly and scar tissue has developed — roughly 40 times.
Some of the 10 cases Daskalos can’t ascertain as successful involve patients not coming back for follow-up, he says. One patient, he adds, complains of some pelvic pain.
“The far majority of cases we do come back with the expected result,” Daskalos says.
Backup contraception must be used for at least three months following the implant of Essure.
Conceptus, the Essure manufacturer, did a five-year follow-up study and determined that when the coils are correctly placed, they are 99.83 percent effective in preventing pregnancy and that serious side effects are rare, according to the Food and Drug Administration.
According to Bayer, Conceptus’ new owner, Essure is correctly placed on the first attempt 96.9 percent of the time.
Other studies say initial placement success ranges from 84 to 98 percent, according to a 2011 review by Mayo Clinic researchers.
The procedure is trickier in women with misshapen uteruses and/or abnormal fallopian tubes.
The FDA approved Essure as a Class III medical device. Class III devices have undergone the agency’s most rigorous premarketing review.
Patients who think they were harmed by a Class III device cannot sue the manufacturers in state court because federal law gives the FDA the authority to determine a device’s safety, the U.S. Supreme Court ruled in 2008.
If a patient insists on having Essure coils taken out, Bayer recommends surgically removing part or all of the fallopian tubes. Some physicians believe a hysterectomy is needed, though other doctors consider that to be excessive.
While sympathetic to those who think Essure has caused them problems, Daskalos and other physicians say it’s possible that what’s actually happening is that symptoms long concealed by the use of hormonal contraception come to light when that use stops.
“If they had been on birth control pills and are no longer on birth control pills, now you’re getting general menstrual and general premenstrual symptons that had been masked by birth control pills,” Daskalos says.