A BLOG BY SHANNON FISHER
Erin Brockovich is giving a voice to many women who say, “No!”
UPDATE 11/12/13: There are now even more reasons to avoid the Essure device! (And more proof that the mission of the group of women spreading word about the device’s severe problems is an extremely valid one.) The manufacturer of Essure, Bayer, has agreed to add the potentially dangerous side effects of Essure to the patient information booklet. The FDA claims claim doctors have already been informed of these side effects – but, if that is true, most doctors have clearly not relayed them to their patients.
Link to ABC investigative report: http://www.abc15.com/dpp/news/local_news/investigations/bayer-changes-essure-patient-booklet-to-include-important-health-warnings-after-abc15-investigation
Erin Brockovich is leading a new crusade, and it appears she has another uphill battle on her hands. She is taking on the FDA and Bayer, the manufacturer of a sterilization device called Essure, in an effort to assist the throngs of women who have contacted her with reports of having experienced severe complications due to the device. Essure was approved for use in the United States in 2002, and more than 600,000 women have had the device implanted to date, but many of these women are being forced to have hysterectomies due to a myriad of Essure-related complications. The only method of complete removal of the device is removal of the uterus.
Essure is a “permanent birth control” device that provides non-surgical sterilization to women. Many gynecologists are implanting these devices in lieu of tubal ligation surgery due to the less invasive nature of the procedure. Small coiled springs containing plastic fibers are placed into the fallopian tubes by a catheter. Over the next three months, body tissue grows around the coils, forming a barrier in the fallopian tubes and thereby permanently preventing sperm from reaching an egg. Essure is essentially absorbed by the body as a permanent part of a woman’s reproductive system, so when complications arise from the device it is often necessary to remove the entire uterus. This negates the purpose of “non surgical” sterilization.
Dr. John Weinstein of Frisco Women’s Health in Frisco, TX, says of a patient, “She had pain on her left side every day after the procedure was performed. She underwent laparoscopy and hysteroscopy and was told the single Essure was removed by pulling it out from inside the uterus. You cannot just pull out an Essure, as it works by becoming part of your fallopian tube and uterus over a 3 month period. The only way to safely remove it is by hysterectomy. I found her Essure just sitting next to her tube, not in her tube at all. Her two years of pain was gone as soon as she woke up [from having a hysterectomy]!”
On her website dedicated to this cause, Brockovich states, “I have been amazed at the number of women who have written to me with their stories and the serious medical issues they are having due to the Essure implant. Stories from debilitating headaches, nausea, allergic response to the nickel the device is made of, hysterectomies, colon perforation due to device moving, to scans that cannot even find where the device has gone to pregnancy – and the women were told that they could not get pregnant, yet none of the women were told of the serious side effects.” You can read some of their stories here: http://www.essureprocedure.net/essure-stories.
More than 700 adverse events reports have been filed with the FDA, in addition to hundreds of letters from other women experiencing complications, with very little response. Knowing there are many more sufferers out there, Brockovich’s goal is to collect 5,000 signatures from women who have had problems with Essure in order to persuade the FDA to take a deeper look into the safety of the device. The goal is to either remove it from the market or mandate that the potential complications of Essure are explained to women before implantation. She also wants them to reverse a pre-emption status that prohibits women who are harmed by this device from seeking legal recourse. (Medical devices that have gone through premarket approval with the FDA can’t be held responsible for injuries caused by the device, even if it is defective.) Anyone suffering from issues related to Essure can connect with others having similar experiences via the website link above.
It isn’t just Brockovich who is taking notice of the rising number of women reporting problems with the device. Angie Firmalino and Michelle Garcia, two women at the forefront of the fight to expose the potential for serious complications with Essure, won a 2013 Justice Served Award from an organization called Let America Know, which grants awards to everyday citizens who fight the system. This award was given for their tireless efforts to raise awareness of the potential risks of this Essure. Their hope is that this issue will receive enough public attention that many more women who are experiencing these kinds of complications will come forward, thereby compelling the FDA to take their reports into account and re-assess the safety of the device.