Essure Birth Control
Complications from EssureBirth Control
The use of Essure female contraceptive devices has been linked to a wide range of serious health complications in women around the globe. The complications caused by Essure have resulted in health consequences ranging from bleeding to death.
Have you been diagnosed with a health complication due to the use of Essure? Allan Berger & Associates is accepting cases involving complications with these female contraceptive devices in the New Orleans area and nationwide.
Studies Show Failed Sterilization Linked to Use of Essure
A recent study published by JAMA found that hysteroscopic sterilization or sterilization through the use of Essure was significantly associated with a higher risk of gynecological complications such as failure to work or requirement of a second round of sterilization. According to the study, around one million women worldwide have undergone the procedure.
When compared to typical means of sterilization or “tube-tying”, Essure resulted in a higher percentage of failure. In the study, 4.83% of Essure patients saw failure after one year and 5.75% after three years, compared to 0.69% and 1.29% of those who experienced the traditional method.
Another study conducted in 2014 found that 9.6% of women could become pregnant within 10 years of undergoing sterilization with Essure. This is nearly four times the estimated risk after a laparoscopic tubal litigation, the more traditional method. According to their study, 96 of every 1,000 women who undergo the Essure sterilization would get pregnant within 10 years.
The manufacturer of Essure states that clinical trial shows the procedure is 99.83% effective at preventing pregnancy over a five-year period when used according to instructions. However, if the insert is not placed correctly or if the patient does not use an alternative form of birth control for three months after placement, pregnancy could still result.
From Black Box Warning Label to Restricted Sale
In 2016, the FDA directed Bayer to conduct a new safety study and add a “black box” label to Essure, which is the strongest type of warning. This warning is only placed on prescription drugs or products by the FDA when there is reasonable evidence of an association of a serious hazard present. Presence of the warning means that a reaction to the drug or product may lead to death or serious injury.
Beyond the black box warning, the FDA directed Bayer to add a comprehensive patient-decision checklist to the label that doctors would need to use to discuss all relevant risks with their patients. Currently, the United States is the last country that allows the sale of Essure. However, as of July 2018, Bayer announced that sales of the birth control device would be halted by the end of 2018. According to Bayer, the removal was due to a “business decision” after a decline in sales.
What is Essure Birth Control?
Essure is a permanent birth control device that is offered as an alternative option to tubal ligation, the more traditional method of sterilization. Essure is marketed as a non-surgical form of birth control, making it sought after for its simplicity.
A small Essure insert is permanently placed into each of the fallopian tubes by a doctor, forming a natural barrier that keeps sperm from reaching eggs, preventing pregnancy. The small, flexible coil insert is made from a nickel and titanium alloy. The barrier is caused by scar tissue that forms around the inserts. According to Essure, the barrier takes approximately three months to form and an alternative form of birth control must be used during this time.
Although Essure is marketed as requiring no anesthesia and done in-office, patients reported many health complications ranging from severe pain to death.
Injuries and Health Complications Caused by Essure
Since Essure’s approval in 2002, women have reported nearly 15,000 Essure-related adverse events and at least 30 Essure-related deaths to the FDA. From 2015 to 2016 alone, the FDA received 11,192 adverse event reports. Some of the most commonly reported problems were:
- Pain, especially in the abdomen
- Heavier menses/menstrual irregularities
- Bleeding
- Headaches
- Fatigue
- Weight fluctuation
- Device incompatibility
- Device migration or breakage
- Allergic reaction to nickel
- Device not operating as expected
- Malposition of the device
- Unintended pregnancies, including ectopic pregnancies
- Fallopian tube, uterus and colon perforation
In 2016, it was reported that Essure could have possibly caused over 300 fetal deaths. However, the FDA currently reports the deaths of four adult women, 18 pregnancy losses, two infant deaths after birth and a possible stillbirth. For women experiencing symptoms from Essure, other complications can arise such as the inability to work, infertility and life-altering surgical procedures to remove the device after migration.
Should I File an Essure Claim?
If you or a loved one has undergone the Essure implantation process, you could be eligible for compensation for your injuries. The majority of states allow plaintiffs to pursue damages and compensation for emotional distress, maternal lost wages, pain,and suffering relating to wrongful pregnancy, medical expenses associated with pregnancy and other expenses associated with failed sterilization.
It’s important to see your physician if you are experiencing any of the side effects or symptoms listed above. Although Essure will no longer be on the market for purchase, individuals with the implant currently could develop symptoms in the future.
If you decide to file a claim, your attorney will work closely with you to build a case by examining your medical records and other pertinent information. Should a case be found, your attorney will file a lawsuit on your behalf.
Call Us For Your Case Evaluation Today
Health complications resulting from Essure are painful both physically and emotionally. At Allan Berger & Associates, we have been successful in many cases involving prescription medications and products. To receive your free case evaluation today, reach out to us by calling or send us a message now.
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