Essure Birth Control Side Effects
(Updated March 28, 2018)
Essure, the permanent form of birth control, has been linked to serious complications. The device, which consists of two metal coils inserted in each fallopian tube, may break and migrate within the body, causing chronic pain and other side effects.
In 2016, the FDA issued a black box warning for Essure—the highest warning it can issue—for its health risks.
Women have complained of side effects like chronic pain, menstrual irregularities, and device migration on support websites like Essure Problems as well as in formal complaints to the FDA.
Thousands of lawsuits filed against Bayer, Essure’s manufacturer, allege that the company was aware of Essure’s high risk for complications but failed to properly warn the public.
If you or a loved one suffered side effects after being implanted with the Essure device, you may be eligible for a lawsuit. Contact our attorneys today for a free case review.
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Essure Side Effects and Complications
Though Bayer advertised Essure as a less invasive alternative to tubal ligation, the device's side effects likely outweigh any benefits.
By the end of 2017, the FDA received more than 25,000 adverse event reports for Essure and 40 reports of death.
Common complications reported by women include:
- Patient-device incompatibility (such as metal allergy)
- Pregnancy losses
- Migration of device or device component
- Malposition of device
- Device not operating as expected
- Device breakage
- Device difficult to insert or remove
Some women have also complained of unexplainable persistent pain after receiving Essure. In some cases, the pain is so debilitating that it interrupts their daily activities.
Essure lawsuits complain of the following side effects:
- Back pain
- Abdominal pain
- Severe cramps
- Pelvic pain
- Kidney pain
- Joint pain
- Weight fluctuations
- Menstrual changes (heavier periods, irregularities, etc.)
- Painful intercourse
Some of these side effects may indicate an autoimmune disorder like lupus. Though the risk is low, a Bayer representative did confirm that there is a chance some Essure patients will develop one of these life-altering diseases.
Essure Coils Can Fracture and Migrate
One of the primary causes of Essure-related pain and complications is the device fracturing and migrating in the body. The coils can break into multiple pieces and migrate within and outside of the fallopian tubes.
Fragments from the metal coils can perforate or embed within the fallopian tubes, uterus, and other organs. Women are not only susceptible to additional injuries when the device moves in this way, but they may also face more complex Essure removal surgeries in the future.
More than half of Essure is made from nickel-titanium alloy. However, nickel allergies are common—the FDA estimates that 20% of women are allergic to nickel.
Often, women won’t know whether or not they have a nickel allergy until they are implanted with the Essure device. Because of this, it’s important to be aware of common nickel allergy symptoms, including:
The FDA initially required that patients were tested for a possible nickel allergy before receiving Essure. Unfortunately, they have since removed that requirement.
Bayer says Essure is 99% effective in preventing pregnancy. But research shows that its failure rate is much higher: 9.6%.
Essure defends against pregnancy by triggering an inflammatory response in the fallopian tubes. This reaction causes scar tissue to build up, which provides a barrier against egg fertilization.
This process, however, takes about three months. Until then, women need to use alternative forms of birth control to prevent pregnancy.
Outside of this three-month period, Bayer says the device is 99% effective in preventing pregnancy. But, research shows that the Essure failure rate is much higher: 9.6%.
Cecilia Bogle told Refinery29 that during her three-month follow-up appointment, she learned that one of the Essure coils had migrated, leaving one of her fallopian tubes open. Ten days later, she discovered she was pregnant.
The FDA has received 1,826 reports of pregnancies in Essure patients. Nearly half of these resulted in pregnancy loss.
Essure's pregnancy risk is greater than older forms of birth control, like tubal ligation. A 2014 U.C. Davis study found that women who used Essure were more than 10 times likely over a 10-year period to get pregnant than women who underwent tubal ligation.
Essure Removal Often Prompts Hysterectomies
Because the Essure device can fracture and migrate, removing the device often requires invasive surgery. Some women have complained that they had to undergo multiple procedures in order to remove the device. In some cases, the metal coils remain indefinitely.
Follow-up surgery is more likely after Essure implantation than tubal ligation. A study published in the British Medical Journal found that one year after receiving Essure, 2.4% of patients required follow-up surgery, compared to only 0.2% of women who underwent tubal ligation surgery.
Hysterectomies (procedures that remove the uterus) are sometimes the only way to remove Essure. This is often the last course of action for Essure patients, as it results in early onset of menopause. Sadly, even young women are often desperate enough to undergo the invasive surgery in hopes of relieving their pain.
Injured by Essure?
Our attorneys are filing lawsuits against Bayer on behalf of Essure victims. If you or a loved one were implanted with the Essure device and suffered complications, you may be entitled to compensation.
Contact us today for a free, no-obligation case review. Our attorneys have the experience and resources to tackle complex litigation such as this. To date, our firm has recovered more than $4 billion for our clients.