Essure contraception side effects have become the center of controversy for Bayer HealthCare, as thousands of women report serious complications. The large number of injury reports regarding Essure contraceptive side effects has prompted the FDA to issue a black box warning label to be added to the Essure birth control warning label.

The FDA issued the black box warning after 13,800 reports of Essure contraception side effects was submitted, with injuries ranging from mild sickness to death. The FDA is also requiring Bayer HealthCare to conduct a new clinical trial to examine long-term Essure contraception side effects.

The clinical trial is set to begin in 2017. It will analyze the outcomes of 1,400 Essure patients and compare the results to women who underwent surgical female sterilization.

Even as the number of Essure contraception side effects reports keep increasing, the FDA opted not to issue a recall at this time. The FDA stated that even with the number of injury reports, the agency cannot ignore the device’s benefits. The Essure birth control device is the only non surgical form of female sterilization, and has been a popular choice for female sterilization since its release in 2002.

The FDA has issued the following statement in regards to Essure contraception side effects:

“After significant review and analysis of available information, the FDA has concluded that Essure is safe and effective for many women but also that some women experience very serious and sometimes debilitating problems … Banning Essure would remove the device from the market for all patients and would limit the options available to physicians and patients. The FDA will continue to consider regulatory options that appropriately balance benefits and risks for the Essure device.”

Overview of Essure Contraception Side Effects

Originally developed by Conceptus Inc., the Essure birth control device was approved through the FDA’s fast track review system. The contraception received quick approval as an innovative alternative to tubal ligation. However, it has been alleged the quick approval process did not allow researchers to fully investigate Essure contraception side effects.

Women typically opt for the Essure birth control device as an alternative to surgery, due to its fast recovery time. The Essure birth control device consists of two metal coils, which are directly implanted into each of the woman’s fallopian tubes. The tissue will eventually swell inside the fallopian tubes, which will ultimately prevent sperm to egg fertilization. The procedure is reportedly 99% effective and only takes 10 minutes.

But despite the convenience of the device allegedly overshadowed the risks of Essure contraception side effects. Since 2002, there have been at least 5,000 injury reports of Essure contraception side effects including:

• Abdominal Pain
• Headache
• Fatigue
• Back Pain
• Cramps
• Vaginal Infections
• Unusual Menstruation
• Allergic Reactions
• Device Perforation and Migration
• Ectopic Pregnancy

Even though these Essure contraception side effects can be potentially devastating for patients, plaintiff in the litigation over Essure say that Bayer HealthCare allegedly failed to warn the public. Patients who experienced Essure contraception side effects may be eligible for legal action and should contact a knowledgeable Essure lawyer.