In 2009, Debra Logan had just taken three months' maternity leave from the Transportation Security Administration at Denver International Airport.
This was her second child, and, she hoped, her last. Logan assumed a tubal ligation (tubes tied) was her best option, though she was dreading asking for the extra time off work. Then her doctor gave her some surprising news.
"She said, 'Oh you can get this Essure thing we have now,'" Logan remembers. "She said ... 'You can come in on a Friday, be to work on a Monday.' And to me that was the selling point."
Following multiple trials, Essure was approved by the Federal Drug Administration in 2002. At the time it was manufactured and marketed by Conceptus, Incorporated — though the company was acquired by Bayer HealthCare in 2013. The device comprises two tiny metal (nickel-titanium alloy) and plastic coils placed in a woman's fallopian tubes, causing formation of scar tissue that seals the openings and prevents fertilization. Essure provides permanent birth control without surgery, and was considered a medical breakthrough when introduced.
Despite that, thousands of women have complained of minor and major side effects from Essure. The FDA reports that it received 5,093 reports on Essure, mostly from women who received the implant, from Nov. 4, 2002, to May 31, 2015. The most common complaints included "pain/abdominal pain (3,353), heavier menses/menstrual irregularities (1,408), headache (1,383), fatigue (966) and weight fluctuations (936)." The most frequent device problems were "patient device incompatibility (941) (for example, possible nickel allergy), migration of the device or device component (482), device operating differently than expected (301), device breakage (259) and malposition of the device (133)."
Logan, who lives in south Colorado Springs, says she was surprised when her doctor put two coils into her body, because she only had one ovary, the left one having been removed due to a cyst two years earlier. She reminded her doctor of the procedure, but she says her doctor insisted both coils were needed. Soon she began experiencing pain on her left side, along with other bizarre symptoms like persistent nausea and panic attacks so bad she had to take medication. She went to her doctor but was told everything was fine.
It wasn't until she discovered the Facebook page "Essure Problems" years later that she began to suspect that something was seriously wrong with the implant. As it turned out, Logan was not only missing an ovary, she was missing a fallopian tube. With nowhere else to go, her left Essure coil had fallen out and landed on her uterus. Logan had surgery to remove the coil, but metal fragments remained in her uterus. In 2014, she had a hysterectomy. Her symptoms disappeared.
Now Logan, 40, is an administrator for Essure Problems and for a regional offshoot Facebook page. The main page has more than 23,000 members worldwide. Like her, many group members have turned to hysterectomies to remove all of Essure's pieces, which can sometimes migrate.
On a sunny Tuesday, Logan invited three other members of Essure Problems to her home to talk about their own experiences. None of the women — 45-year-old Shannon Wofford, 39-year-old Jennifer Abeyta and 41-year-old Leah Spencer — had originally sought out Essure.
In 2006, Wofford was told by her doctor that another pregnancy would kill her. She had just given birth to her fourth child, but had been on bed rest the entire pregnancy. (Wofford had also previously served as a surrogate mom, giving birth to two sets of triplets.) Wofford asked her doctor to give her a hysterectomy, but she was at a Catholic hospital in Missouri, and the doctor refused on moral grounds. He convinced Wofford, a former nurse, that Essure was safe.
Both Abeyta and Spencer were newly married when they got Essure. Abeyta wanted her tubes tied, since her husband wasn't yet on her insurance and thus a vasectomy wouldn't be covered. Spencer was looking for birth control that would work for her — taking pills had landed her in a psychiatric ward with suicidal ideation. Both say their doctors convinced them Essure was their best option.
Abeyta described a dizzying list of symptoms that followed the procedure, from decreased thyroid function to low Vitamin D, cysts and acne, brain fuzziness, pain, anxiety, hair loss, vomiting and more. Two years after getting Essure, in 2013, her ovary twisted, cutting off blood flow. The ovary inflated and burst, causing internal bleeding.
"They had to do emergency surgery to remove it," Abeyta says. "But of course, they left the coil, which migrated to the left side and landed on a nerve. So I was bedridden for about three months, waiting for a hysterectomy."
During the wait, she discovered Essure Problems. After the hysterectomy, she says all her symptoms, except for hair loss, immediately disappeared.
Spencer went through a similar debacle. Getting Essure implanted was incredibly painful, and afterward, sex became excruciating. In fact, just about everything caused her pain.
"My cat would barely touch me and it would just send me through the roof," she says. "So I went to see my doctor, and she was like, 'Oh, you have fibromyalgia.' And I'm like, 'Where did all this come from?' And she goes, 'Well, you're getting old.'"
More symptoms followed. Her thyroid wasn't functioning correctly. Her Vitamin D levels were low. She was anemic. She had dental problems. One ear itched constantly.
She took tests, and saw specialists, even a neurologist.
"I literally thought I was going crazy," says Spencer, who was then living in Iowa.
Then, in 2013, she found Essure Problems. After a hysterectomy, most symptoms (with the exception of vertigo and migraines) disappeared.
Wofford still has her Essure. She discovered Essure Problems this summer, after moving to Colorado, and says she's waiting for her insurance to kick in so she too can get a hysterectomy.
Her teeth are falling out, her body is covered in cysts, one ear rings constantly, her period is irregular and she's had two cardiac events.
She's so tired that she drinks energy drinks constantly to stay awake at her job. She says she's mad at herself for not looking into Essure before getting it.
"I feel like the Tin Man all day long," she says, "needing to be oiled."
The women have their suspicions about what's caused their symptoms. All claim to have an allergy to nickel, which is in the coils, and they point to the possible dangers of plastic, and of hormonal reactions to blocking the fallopian tubes. But they can't sue Bayer because the device is considered "Class III" by the FDA, meaning it underwent extensive reviews. Because of this, personal injury suits are preempted under federal law.
Essure Problems has lobbied for the medical device to be banned. U.S. Rep. Mike Fitzpatrick, R-Pa., plans to introduce the "E-free Act" on Nov. 4 in response to the problems, though his office has declined to comment on exactly what the act would do.
FDA spokesperson Deborah Kotz notes in an email that in response to patient outcry, the FDA "convened an advisory committee meeting on September 24 to hear expert scientific and clinical opinions on the risks and benefits of the device and to hear more from women who have used Essure."
The FDA is reviewing the data to see if further actions are warranted.
Meanwhile, the FDA continues to be criticized for approving Essure in the first place, when initial and subsequent trials were neither resoundingly positive (adverse effects included pain, pregnancy and perforated fallopian tubes, for example) nor complete. In May 2013, The New York Times ran an article detailing those trials, noting, among other things, a long-term study on Essure's effects failed to include data on 30 percent of the participants.
While stressing risk factors and advising women to consult with their physicians before implanting Essure, Bayer is standing by its device. A recent press release said Bayer was taking patient concerns seriously, but that the benefits of Essure outweigh the risks, and the product has been tested on more than 10,000 women.
"Since there is a high percentage of women who use permanent birth control, it is critical that they have access to a wide range of safe and effective birth control options to fit their needs," the press release stated.
"The safety and efficacy of Essure is supported by more than a decade of research and development and real world clinical experience."
Well Ill give ya that one Robert and agree.
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