Michelle Morton's chronic pain may have been caused by her birth control.
Michelle Morton, a North Carolina mom of three boys, woke up with a mysterious abdominal pain one cold winter day four years ago. At first she didn’t think much of it.
“It felt very similar to trapped gas,” she remembers. The sharp, constant pain clawed at her lower right side, and after a couple weeks, it still had not gone away.
That’s when Michelle, now 45, became concerned.
She went to her ob-gyn, who examined her and found nothing abnormal on an ultrasound. The OB suggested it might be a gastrointestinal issue, so she visited a specialist and underwent a colonoscopy. Everything was normal.
She went to a urologist, growing increasingly desperate for answers. Every day, she was waking up feeling bloated, as though she was about to get her period. Fatigue set in, hampering her daily activities, like caring for her sons and running her own business as a self-employed professional organizer.
“I bounced around between my gynecologist, gastroenterologist, and urologist,” she says. “But nothing was ever found. And the pain wouldn’t go away.”
Several years passed, as Michelle’s health declined. She had to let a lot of her business go as her condition worsened. At one point, her adrenal glands started to fail. These two glands, which sit just above your kidneys, are essential for life, producing a variety of hormones like adrenaline and cortisol that help your body function.
Still without answers, Michelle saw three different endocrinologists — specialists who treat hormonal disorders — and was tested for multiple autoimmune diseases. Again, the results came back negative.
But Michelle had no doubt that her body seemed to be shutting down.
It wasn’t until she came across a friend’s Facebook post last October that she finally put together the pieces of her nearly four year medical mystery.
The Facebook post linked to a news article about a birth control implant called Essure. The article detailed how the FDA had held a panel meeting to evaluate Essure’s safety after thousands of women complained of harmful side effects they’d allegedly suffered as a result of its placement.
“My chin dropped,” Michelle says. “This made absolute sense.”
Around the time her pain started, in early 2012, she’d elected to have the Essure device, a metal coil, inserted into each of her fallopian tubes as a form of permanent birth control. Bayer, the manufacturer, markets Essure as a nonsurgical alternative to getting one’s tubes tied. The coil is meant to induce inflammation in the fallopian tubes, impeding any egg from becoming fertilized.
The short procedure was performed by Michelle’s gynecologist in the office. Michelle was told that some discomfort afterward was normal. But later, when she went back complaining of abdominal pain, the gynecologist never suggested Essure could be the cause.
Armed with her newfound suspicions, Michelle requested all her medical records and created a timeline of every symptom and test, starting after her Essure implant.
“When it was all there in black and white, it was very eye-opening,” she says now. “It really made a huge difference to go through and write everything out.”
She immediately joined a Facebook group of women who had encountered health problems after getting Essure. The closed group, called “Essure Problems,” has more than 27,000 members.
Further research led her to consult with several new specialists about how to recover from her ordeal. After weighing three or four different opinions, she opted to have her uterus removed in December.
For her, it was, she says, “the safest route.”
However, some doctors believe that opting for a hysterectomy is overkill for many patients with Essure.
“There are safe, thorough ways to remove Essure without a hysterectomy,” says Dr. E. Scott Sills, a fertility surgeon at the Center for Advanced Genetics in Carlsbad, CA. He’s removed about 100 Essure coils via a minimally invasive procedure, and some of his patients have gone on to become pregnant and give birth to healthy babies through IVF.
“There still will be some women who need a hysterectomy,” he acknowledges, “like those with fibroids, endometrial polyps, or other gynecological problems, but it’s a small minority of women.”
Only six weeks after surgery, Michelle feels shockingly improved. Her fatigue, bloat, and pain have disappeared.
“I feel so much better,” she remarks. “I’m hoping it stays like this.”
She now believes that her strange autoimmune issues developed as a result of an allergy to nickel in the Essure coil. The device is marketed as stainless steel, but Michelle’s attorney, Holly Ennis, says nickel components exist in it and patients are not being told.
In addition, Ennis alleges, in many cases, the coils have broken or fractured within women’s bodies, or migrated to unintended places like the uterus or the abdominal cavity, producing inflammation and scar tissue.
“I talk to women every single day who have had problems,” says Ennis, of the law firm Ennis & Ennis, P.A., whose Essure-related clients number in the hundreds. Around 750,000 women have received Essure.
But Bayer has defended its safety. In a letter to physicians last year, Bayer’s VP of U.S. Medical Affairs, Edio Zampaglione, wrote, “I want to assure you that, although some media articles may imply otherwise, the safety and efficacy profile of Essure has not changed. All of the available data and analyses continue to confirm that Essure is a safe and effective permanent birth control option.”
Michelle, like many women, strongly disagrees. She has considered legal action, but because Essure received a certain kind of FDA approval in 2002 based on stringent clinical testing, any lawsuits are “pre-empted,” meaning that it is granted immunity from lawsuits.
“All of these women who have been significantly injured and undergone hysterectomies basically have no legal recourse,” says Ennis, who is working to circumvent the pre-emption with some strategic maneuvering that she likened to “threading a needle.”
Questions have also been raised about the validity of the original clinical trials that led to Essure’s approval; according to Ennis, 197 women tried the device for two years and 30 percent of them were “lost” during the follow-up phase, which Ennis believes may imply that those who suffered adverse events were eliminated from the data.
So far, the FDA has not decided to recall Essure, which Ennis says would help patients like Michelle mount lawsuits. Instead, this week, the FDA called for new, mandatory research to determine the risks of Essure, and announced plans to mandate a box warning explaining “the adverse events that have been associated with” use of the product.
Still, Michelle is committed to taking her fight to the top. She’s already visited Washington, D.C., with a fellow Essure patient to lobby her congressman to ban the device altogether. And she’s hoping to help others organize their own medical records and take charge of their health care.
“I’ve really learned that the best advocate is yourself,” she declares. “It’s hard because doctors can make you feel like you’re crazy, but we know ourselves and you have to trust that.”
From Cosmo US
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