May 8, 2018 – San Diego, CA. A noted obstetrician and gynecologist based in Chicago has recently talked to the media about the hundreds of women he’s treated with the Bayer birth control device called Essure. He wants to make sure women know of the potential health problems with this permanent contraceptive implant. But what is Bayer’s Essure device?
What is the Essure Contraceptive Implant?
Essure is a type of permanent contraceptive implant made by Bayer and has been on the market for about ten years. Bayer HealthCare Pharmaceuticals claims that this device is 99% effective in preventing pregnancy, and mentions that it’s the only device that you can get with a “non-surgical” procedure.
The device is a small metal polyester coil that once placed into a woman’s fallopian tubes makes her completely and permanently sterile. It acts by creating an inflammatory response in the body which creates scar tissue and basically blocks the fallopian tubes passage way.
Recently, news stories have reported problems women have had once they’ve had the device inserted.
Dr. Brett Cassidy is based in Yorkville, Illinois and has worked at several hospitals in the region. He specializes in Obstetrics & Gynecology. He recently did a video for the Chicago Tribune where he discussed the problems associated with trying to remove the Essure coils from women’s uterus.
Watch the full video here: http://www.chicagotribune.com/lifestyles/health/98365218-132.html
What are the problems or complications with Essure birth control?
Essure has been linked to a multitude of adverse side effects by thousands of women who had the metal coils inserted. Side effects can range from mild to severe; some may even be life-threatening. In 2017 the FDA received 12,000 new adverse (hurt or injured) reports related to Essure.
The following symptoms and side effects have been reported by women who had Essure inserted:
- Heavy or irregular menstrual cycles
- Weight gain or loss
- Allergies to nickel
- Pregnancy, ectopic pregnancy
- Device migration
- Perforation of organs
- Broken or missing coils
- Chronic pelvic pain
- Pain – lower back, hip, joint, chest, leg, neck, spine
- Hair loss
- Hair growth in new places
- Headaches or migraines
- Nausea, vomiting
- Malaise, general feeling of illness or discomfort
- Severe bloating
- Night sweats
- Loss of libido
- Bleeding/spotting after sex
- Painful intercourse (dyspareunia)
- Yeast infections
- Bacterial vaginosis
- Urinary tract infections (UTIs) or bladder infections
- Blood in urine
- Swelling, inflammation of cervix or vagina
- Itching, burning, stabbing pain at vaginal opening
- Breast pain, tenderness
- Constipation, gas, diarrhea
- Metallic taste in mouth
- Mood swings
- Tingling sensations
- Brain fog, forgetfulness
- Fainting/black out spells
- Blood clots
- Vitamin D or B12 deficiencies
- Anemia, iron deficiency
- Hives, rashes, skin irritation
- Dental issues
- Thyroid disease
- Swelling of legs, feet
- Muscle spasms
- Vision problems
- Excessive sweating
- Dry skin, hair or eyes
Can Essure birth control fail?
Yes. Essure has been linked to hundreds of unplanned pregnancies, in some cases after a woman has undergone a hysterosalpingogram (HSG) to ensure the tubes are closed.
While no form of birth control is 100 percent effective all of the time, women may be at a greater risk of becoming pregnant with Essure than tubal ligation. One study published in the journal Contraception estimated that 9.6 percent of women could become pregnant within 10 years of undergoing the Essure procedure. That is about four times the risk after tubal ligation.
Between 2002 and 2015, over 630 pregnancies were reported to the FDA by women who had Essure inserted but became pregnant anyway.
Women who have Essure inserted and subsequently become pregnant are at a greater risk for ectopic pregnancies. Ectopic pregnancies occur when the fertilized egg implants itself anywhere except the uterus. Oftentimes, the fertilized egg implants itself in the fallopian tubes. Ectopic pregnancies are serious and life-threatening to both mother and baby. In most cases the baby does not survive.
Essure is made with metals – is this a health concern?
The Essure device consists of two small metal coils that are placed inside each fallopian tube. The metal coils are made of an outer nickel titanium alloy coil and an inner stainless steel coil. It is the nickel metal that is of major concern.
How is a nickel allergy linked to Essure?
The Essure insert is made of materials that include a nickel-titanium alloy. Once the inserts are placed inside the body, small amounts of nickel are released from the inserts. Women who are allergic to nickel could potentially have a severe allergic reaction to the inserts.
According to a study reviewing reported adverse events associated with nickel hypersensitivity in patients with Essure implants, the suspected nickel hypersensitivity is small, but is reported as very painful and severe. Reports were reviewed from 2001 through July 21, 2010 and over 650 patients’ results were tested.
Wrapped around the inner stainless steel coil are PET (polyethelene) fibers. Please read our blog titled: Autoimmune Disease and Metal Exposure | Essure contains metal – what you should know.
The PET fibers stimulate the growth of scar tissue by acting as an irritant to the fallopian tubes. The inner coil holds the PET fibers in place while the outer coil is intended to act as an anchor and hold the entire device in the fallopian tubes.
Why is Essure still being sold if it creates health problems?
Bayer has halted sales in many European countries in the last two years stating “slow sales”, however many of these countries health departments have banned the Essure device claiming numerous health risks or violations.
What about American sales? Bayer continues to sell this product in the U.S. despite being slapped with a FDA Black Box warning, the strongest consumer warning the agency has. Since the package warning was applied – sales dropped about 70% in the last two years, yet still being offered.
The FDA took further action recently by mandating all doctors must have women who are thinking about Essure sign-off on a sheet explaining the dangers of the device. They must also read the black box warning.
We applaud Dr. Brett Cassidy in talking and creating a video to explain his experiences with treating women who have elected to have Essure removed.
Essure Claims Evaluation
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