History of Essure Problems
Approved by the FDA in 2002, Essure was originally manufactured by Conceptus Inc., which was purchased by Bayer for $1.1 billion in 2013. Right around that same time, thousands of women began to come forward to discuss in public the “excruciating” pain and serious medical problems they suffered after being implanted with Essure. Despite Bayer’s claims that Essure is safe and effective, users say that the metal coils caused them to experience severe pain, migraines, neurological damage and fallopian tube perforation, and some women have even died as a result of their complications. Women who participated in Essure clinical trials have since claimed that Conceptus researchers intentionally concealed reports of users suffering severe pain after receiving the birth control implant, and even manipulated their findings to get the device approved.
Alleged Essure Complications
- Migration of the implant to other parts of the body
- Severe pain
- Perforation of the fallopian tubes or uterus
- Unintended pregnancy
- Allergic reaction to the implant’s nickel components
- Requiring a hysterectomy to remove the implant
- Wrongful death
What is Essure Birth Control?
Essure is a prescription, non-hormonal birth control device implanted in the fallopian tubes to provide permanent protection against pregnancy, an alternative to more invasive forms of surgical sterilization, like tubal ligation. Essure consists of two metal coils made of stainless steel, nickel titanium and polyethylene fibers designed to cause the buildup of scar tissue within the fallopian tubes, forming a barrier that permanently prevents fertilization. Insertion of the Essure device is intended to be nonreversible, and Bayer markets the sterilization implant as the only “FDA-approved permanent form of birth control with a procedure that can be performed in an office setting with general anesthesia.”
Why Are Lawsuits Being Filed?
Current Essure lawsuits claim:
- Bayer manufactured a defective and unreasonably dangerous device.
- Bayer marketers intentionally misled women implanted with Essure.
- The manufactuerer violated the conditions of its premarket approval from the FDA.
- The manufacturer failed to adequately warn consumers about the risk of Essure complications.
- Bayer failed to issue an Essure recall.
- The manufactuerer overstated the benefits of Essure and downplayed its risks
Essure Lawsuit Information
The first Essure lawsuit was brought against Bayer in Philadelphia civil court in July 2014, and the complaint stated that Essure “should never have been marketed or sold” to the plaintiff, who alleged that Bayer Healthcare intentionally misled women implanted with the sterilization device, and violated the conditions upon which it received premarket approval from the FDA. In the years since, women across the country have come forward with stories of chronic pain, bleeding, hospitalizations and autoimmune disorders they have suffered after being implanted with Essure. It wasn’t until February 2016, that the FDA finally required Essure to carry a “black box” warning highlighting the potential for the device to migrate out of position and perforate the uterus or fallopian tubes, although many believe Essure should have been recalled altogether.
It is estimated that about 750,000 women have been implanted with the Essure birth control device, and prior to the FDA panel review of the sterilization implant in September 2015, the FDA reported that it had identified as many as 20,000 complaints from women who shared their Essure horror stories on social media. As more information comes to light about the potential for Essure to cause serious problems in users, a growing number of lawsuits are expected to be brought against Bayer.
If you believe you have been adversely affected by side effects of Essure birth control, you may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering. Consult a knowledgeable product liability lawyer today to discuss the possibility of filing an Essure lawsuit against Bayer.
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