Women blame birth control Essure for medical complications, pain
9:47 PM, Nov 7, 2013
5:33 AM, Nov 8, 2013
Thousands of women have taken to social media to complain about a popular
birth control device they say has devastated their bodies, causing some to require hysterectomies. For many, the complications could come from a nickel allergy the device's manufacturer didn't always warn about on its label.
Harford County mom Krystal Donahue is prepping for a surgery many women her age usually don't have to consider for years.
"I never thought at 37 I would have everything gone. It's kind of like your womanhood is ripped out from you," Donahue said.
Maribel Zurita, 36, is also facing the same grim reality.
"I'm out of options. I've exhausted all options so now I'm due to get a total hysterectomy," Zurita told us.
These two women are taking drastic steps to get their bodies back to normal. They are finally going to put an end to the health nightmares they say started with two tiny metal coils.
"My body was just devastated," said Zurita.
Both women say their bodies were damaged by a birth control device called Essure.
The method of birth control uses coils placed into a woman's fallopian tubes, creating a similar effect to having your tubes tied. The coils eventually scar over, closing the path for good. Some women are attracted to the procedure because it does not require surgery.
Thousands of women however have claimed to suffer serious issues caused by Essure. Some of the issues reported include bloating, back and belly pain, headaches, cysts and more.
Almost 3,000 women have share their agony on a Facebook page designed to let women share their pictures, their anger and their stories.
"We pretty much all share the same problems. You pretty much throw them in a pot and you just pull them out one by one and everybody's got the same issues," Essure patient Vashion Merchant said.
"Every day I read the symptoms and I shake my head, [thinking] yeah, that's exactly what I'm going through," Donahue said.
The company that makes and sells Essure is required to report complaints to the Food and Drug Administration.
There are more than 943 adverse reaction reports from patients and doctors on the FDA's website dating back to 2002 when the device was first approved, records show.
More than 600 women (606) cited pain as a problem.
In more than 150 cases (153) doctors reported the device breaking or moving with the coils perforating the fallopian tubes or uterus.
Records show at least 91 women needed a hysterectomy to remove the device.
That's the procedure Donahue and Zurita will undergo later this month.
"I can't wait to feel normal again and I'm scared I'll never feel normal again," said Donahue.
Normalcy is all these women want after the pain they've gone through.
For at least one patient - the situation was tragic. At least one woman has died according to FDA records detailing Essure's reports.
Those records show the woman went to the emergency room with stomach pain. The doctor's report says her cervix, fallopian tubes and uterus were necrotic, essentially dying, when the patient was seen and that she had a form of strep.
But the report stopped short of blaming her death on the device with attending physician saying it was not related to Essure.
OB-Gyn Dr. Danielle Staecker was involved in the clinical trials for Essure when she worked at Howard County Hospital. The device was originally put on the market by a company called Conceptus, which was bought by Bayer in June.
Like Bayer, Staecker believes the birth control is safe. But she says only for the right woman—a woman without a nickel allergy.
"They are made of titanium steel with a little nickel, so another important thing to tell your doctor if you are interested in this is nickel allergy is very common," said Staecker.
Records show allergy problems have been reported again and again to the FDA, with as many as 113 reports related to potential nickel allergies.
When originally approved by the FDA, the device advised women to have a skin test performed before inserting the device.
However, in July 2011, the manufacturer convinced the FDA to remove that skin test warning and sent out a press release saying the label change expanded the number of potential patients who could use the device.
A Bayer spokeswoman says the current label does warn about nickel allergies. The company has since supplied a video statement in response to media inquiries about Essure.
"We take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause, " said Dr. Edio Zampaglione, with U.S. Medical Affairs for Bayer HealthCare.
The company also says the FDA complaints reflect just a small percentage of the more than 750,000 women who use the device worldwide.
The patients we spoke with want the device pulled from the market. But they know that's doubtful. So is their option to pursue legal action against the maker. Legally, they are not able to do so.
Essure patients cannot seek legal recourse through lawsuits because of an FDA rule called preemption that protects the manufacturer and makes them virtually impossible to sue. But the impacted women now have a big name activist in their corner to fight the rule, Erin Brockovich.
"I was just astounded at what I was reading and more angered that there was going to be no recourse for these women," Brockovich said, "I don't know what else it takes for us to look at a group of women,
thousands of them that are having a problem, that maybe something is wrong."