October 31, 2017 – San Diego, Ca. — The DailyMail.com, a British publication, broke a news story yesterday on one woman’s horror story with the birth device called Essure. At age 43 she had a surprise baby and decided to get permanent birth control.
“Jackie was told her implant was an easy alternative to sterilization…but the reality was horrifyingly different”
Her story is one of many since Bayer Pharmaceuticals released the Essure device to the world. It’s estimated that close to 1 million women worldwide have chosen the Essure coils for birth control. Over 34,000 have complained and claim Essure has caused them numerous problems. In the U.S. there are over 10,700 lawsuits stacked up and waiting for litigation.
According to Jackie: “The doctor got one of the springs in but couldn’t get the other into position. I was told to come back eight weeks later for a traditional sterilization”. That’s when her problems started.
“I went back and forth to the doctor but kept being sent away with painkillers”
“Finally, last year I met a GP who took the problem seriously. She referred me to a kidney specialist who said she could see an unidentified object on an X-ray.
She sent me to a gynecologist who discovered that when they sterilized me with the clips, they had left the Essure in. I’ve now found out Essure is made of nickel which I’m allergic to.”
Background: What is Essure Birth Control?
Essure is a form of permanent birth control (sterilization) that involves placing two metal coils in a woman’s fallopian tubes. Essure is the only non-surgical form of permanent contraception available today. The procedure is performed in a doctor’s office usually in less than 30 minutes.
How does Essure work exactly? Essure works by blocking the fallopian tubes so sperm cannot reach an egg to fertilize it. The Essure device consists of two metal coils that are inserted into each fallopian tube by a doctor. The coils cause the body to create scar tissue, which blocks sperm from entering the fallopian tubes. This process is intended to be permanent and usually cannot be reversed; women who may want more children in the future should not get Essure.
What is the Essure procedure?
Essure is inserted into each fallopian tube by a doctor. The coils are inserted through the vagina so no incision is necessary. The doctor first inserts a small camera called a hysteroscope through the vagina, into the cervix and up the uterus until he or she can see the fallopian tubes. The doctor then passes the Essure coils through the hysteroscope and into the fallopian tubes.
The correct placement is essential in order for Essure to work as intended. About three to eight rings should extend into the uterine cavity; the rest of the coils should be inside the fallopian tubes.
What has the F.D.A. done about Essure other than a Black Box warning?
Note much has been done to halt or ban the sale of Essure in the U.S. Bayer has halted sales of Essure in most European countries but continues to sell in the U.S. Bayer’s general reason it halted sales was “due to slow sales”. Bayer also missed a key deadline when it failed to comply with the F.D.A.’s mandated 1 year postmarket study which was due on September 2, 2017. As of today, they still haven’t complied.
The FDA approved the device in 2002 after a fast-track review process. The FDA, in a redacted study, has now counted 5,019 adverse affects and problems related to Essure.
The original manufacturer, Conceptus, was acquired by Bayer HealthCare, which continued to heavily market the device. Bayer says that the product is in use in 23 countries and there may be as many as 750,000 devices currently in use. It is unsure of how many women in the U.S. have the device.
Bayer HealthCare is now being accused of possibly having provided fraudulent clinical trials of Essure to the FDA. 17 women, who were part of the trials, have now joined forces and created a consumer advocacy group on Facebook, https://www.facebook.com/groups/Essureproblems/, with 34,724 members as of August 2017.
Last November, the FDA announced it had approved Bayer’s proposed black box warning and patient checklist for its Essure permanent birth control device. The agency said the new warning and checklist, was added to the Essure label.
But is the Essure black box warning enough? According to a recent study, it was found that 90% of women offered Essure weren’t shown the black box warning or the new checklist from the doctors.
What about the Essure Lawsuits in the U.S. is there help for victims?
The lawyers and attorneys at Nationalinjuryhelp.com has issued this statement:
“Because we feel strongly that Bayer HealthCare rushed this product to market and the FDA did fast-track the process, women have been the unwilling victims of profit over safety. We intend to hold Bayer Healthcare responsible for the pain and continued suffering of thousands of women who have had the Essure Contraceptive device implanted. If you, or someone you love, has had the Essure Contraceptive Implant and has had ANY adverse side effect we’re on your side. Contact our lawyers and attorneys today for a FREE case review. Doing so will provide you with the knowledge that you need to make a sound decision regarding how you should proceed through this difficult time.” Read more about the Essure lawsuits here.