A 25-year-old Florida mother says she's one of hundreds -- possibly thousands -- of women across the country who have had to have hysterectomies after a reaction to a form of permanent birth control.
WKMG-TV reported that Nikki Morris from Haines City had an Essure procedure after having three children. The procedure involves a device being placed in a woman's fallopian tubes, causing tissue to grow around it and to thus prevent sperm from reaching eggs.
The micro-coiled Essure device is placed in the woman's fallopian tubes, causing tissue to grow around it and block sperm from reaching eggs. (Image source: YouTube)
The device, however, contains nickel -- a metal Morris later learned she is allergic to.
After the procedure Morris said she couldn't eat, sleep or even stand due to the pain.
"I remember telling my husband every night before bed to please check on me and make sure I keep breathing, cause I would go to bed every night scared to death I wasn't going to wake up the next morning," Morris told WKMG.
But Morris' doctor told her there wasn't enough nickel alloy in the device to cause such a reaction.
The only way to remove the device was for Morris to have her uterus and fallopian tubes removed.
"I was 25 years old and had to have a hysterectomy, I don't think that’s acceptable at all," Morris told WKMG.
And she's not alone.
Hundreds of women and doctors have filed Adverse Event Reports with the Food and Drug Administration about the birth control made by Conceptus, Inc., owned by Bayer, which was approved in 2002. One report said a woman died after being hospitalized with abdominal pain within a year of having the Essure device implanted, though the official cause of death was not determined.
"I laid in bed and told my husband, that pain is gone. Having the Essure coils was the worst decision I've ever made in my life. Having them removed was the best decision I've ever made in my life," Atlanta mother Holly Bruce said told WGCL-TV last week.
Thousands of woman have joined a Facebook group about the problems related to the device.
Erin Brockovich, the woman who championed a 1993 multimillion-dollar groundwater contamination case, has taken up the cause as well.
"There's something wrong with the device, in my opinion," Brockovich told ABC News. "It's a form of permanent birth control, and women's organs are being perforated … it's ridiculous that at any level we try to defend this. If 30 women did suffer harm for unknown reason, we'd investigate. We have thousands injured. I don't think it's safe."
Brockovich pointed out that women experiencing negative side effects from the device do not have legal recourse against the Bayer due to the FDA deeming it a class three device, qualifying it for preemption, which prevents lawsuits against the manufacturer.
Last week, the FDA was compelled to make a statement about the women experiencing problems with Essure. Here's a portion of the statement that ultimately defends its review and approval of the procedure (emphasis added):
The FDA has reviewed Essure patient reports of problems (including web-based testimonials) and adverse event reports submitted to the FDA from a variety of sources, including doctors, patients, and the manufacturer of Essure," the statement The agency also reviewed the results from a five-year follow-up post-approval study conducted by the device manufacturer that was required by the FDA as part of the product's 2002 approval. In addition, the FDA evaluated the available clinical literature to determine what long-term complications may be associated with Essure. To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement.
We take reports of problems with Essure very seriously and will continue to review them carefully. Since approval in 2002, there have been some 750,000 procedures performed worldwide. No form of birth control is 100 percent effective and scientific evidence reviewed by the FDA shows that Essure is a highly effective means of sterilization when used according to instructions. Essure is the only non-surgical sterilization choice for women who want permanent birth control. Although there is evidence of complications, as there are with all medical devices, overall results from the study did not demonstrate any news safety problems or an increase incidence of problems already known. We will continue to monitor the safety of this product to make certain its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks of the device.
Bayer's Head of U.S. External Communications Rosemarie Yancosek released a comment in response to the recent negative coverage about the Essure device as well.
At Bayer, we care about patients and 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, irrespective of the cause. Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effectiveness. Approximately 750,000 women worldwide rely upon the Essure procedure for permanent birth control. A recent practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) has recognized that hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost, and resource requirements.
No form of birth control is without risk or should be considered appropriate for every woman. It is important that women discuss the risks and benefits of any birth control option with their physicians.
Thank you again for allowing us to provide our commentary.
Watch Essure's video about how the procedure works:
WKMG included a fellow Florida mother, 44-year-old Heather Hare, who said she had problems with Essure, but after having a hysterectomy in October, felt better almost instantly.
Gynecological surgeon Dr. Steven McCarus told WKMG he has honest conversations with his patients about the risks of the Essure device.
"There's a lot of stakeholders in this process, we all have to collaborate, get the information to the patient, answers the patients questions and concerns and try to make a good decision," he said.