When it was manufactured, Essure had been hailed as a breakthrough in birth control for women. The product had been marketed as an easy way to achieve female sterilization. However, the reality of the product has turned out to be much different for those who have received this treatment. In large numbers, women have been reporting significant side effects from Essure, ranging from unintended pregnancy to more severe complications including death. Some of these problems have caused significant adverse consequences that has resulted in a variety of damages to recipients. As a result, there have been a large number of lawsuits against the manufacturer of this product. If you believe that you have been injured by Essure, you can join in these lawsuits.
Essure was originally developed and made by Conceptus Inc. The product received FDA approval in 2002. In 2013, Conceptus was acquired by German pharmaceutical giant AG Bayer. Since its approval by the FDA, over 750,000 women have received a treatment that has involved the insertion of Essure.
How Essure Works
Essure is an insert that is placed into a women’s fallopian tubes. It is considered to be an alternative to a tubal ligation procedure. Essure is a coil and is placed in each of the tubes. The coil is made out of stainless steel, polyester fibers and nickel-titanium. The insert is supposed to help form a barrier that can be a blockage that forms around the insert. The product is designed to cause an inflammatory reaction that acts on the tubes. This barrier is composed of scar tissue and is intended to prevent sperm from reaching the fallopian tubes. Essure is intended to be a permanent procedure. It is marketed as a minimally invasive and easy way to achieve permanent female sterilization.
Complications from Essure
In the early years that Essure was in use, there was a small, but steady number of complaints about adverse side effects from the procedure. However, after the potential adverse side effects began to receive attention online and in the media, the number of complaints grew dramatically. In 2011, a Facebook page was established where women shared stories of the health effects that they had experienced due to Essure. Between 2013, when the issues first began to receive attention, and 2015, there were over 5,000 complaints filed about complications that have been experienced as a result of Essure. The number of complaints still continues to grow as more women still experience side effects from the product. According to the FDA, as of the end of 2017, there were over 25,000 complaints filed with the FDA. Given the large number of women who have received the treatment, even a small rate of women suffering from severe side effects represents notionally a large number of complaints.
The side effects from Essure can be severe. There are side effects that occur within the first year after insertion of Essure. These side effects involve pain and cramping. The pain can be either menstrual or abdominal pain. It is the longer-term side effects that present more critical health dangers to women. These complications involve severe pain and extremely heavy menstruations. In some instances, the implant shifts and can impact other areas of the body outside of the fallopian tubes. In some of the most severe cases, patients had to receive a hysterectomy due to the complications from Essure. Other severe complications include a perforation or break in the coil which causes internal damage and bleeding. In addition, there is a variety of other less severe, yet still difficult side effects that have resulted from use of Essure including weight change, hair loss, fatigue and muscle weakness. There are several instances of death alleged due to Essure.
FDA Investigation
After the reports of the complications arising from Essure, the FDA launched an investigation of the product. Given the risks from Essure that have been documented, the FDA directed that the product include a warning on the box of the side effects. In addition, there is a checklist now required for doctors to discuss with patients before inserting Essure. Patients must know of all of the risks in order for them to give their informed consent to the procedure. Only doctors that have completed the checklist may purchase Essure for use in a procedure. In the meantime, however, sales of Essure have dropped precipitously due to the reports of complications. As a result, Bayer announced that it will discontinue selling the product in the United States.
Lawsuits Against Bayer
As a result of the numerous effects of Essure, Bayer faces a multitude of lawsuit seeking to hold it legally liable for the complications that have been caused. At present, there are thousands of pending actions in cases relating to Essure. These cases have been filed in jurisdictions across the country. One of the larger suits is currently pending in the Eastern District of Pennsylvania.
Given that Essure received FDA approval. It had largely been shielded from product liability claims. However, a federal judge has allowed some Essure-related claims to proceed under state law theories. Bayer has failed in its attempts to have these cases moved to federal court under a preemption theory.
Since Essure received FDA approval, many of these lawsuits allege illegality in the way that Essure has been marketed. The complaints take issue with the fact that Bayer is alleged to have paid doctors millions of dollars in consulting fees related to the product. These same doctors allegedly then used Essure in procedures for their patients. In addition, the lawsuits have alleged that Bayer inadequately trained doctors in how to use the product.
One of the more prevalent claims that Bayer has faced is that the product did not comply with federal law since it was dangerous and that Bayer failed to adequately warn users of the dangers associated with the product. The plaintiffs claim that Bayer made several negligent misrepresentations when marketing the product that induced users to opt for a procedure to implant Essure. One of these claims was that Essure would completely prevent the risk of pregnancy. However, the plaintiffs allege that it was known during the testing phase that some patients actually did get pregnant after receiving Essure. In addition, these suits claim that Bayer actively concealed instances in which the Essure caused perforation in the patient’s tubes.
If you have received an Essure implant and suspect that you have suffered complications from the product, you should immediately contact a lawyer. Once you do so, the lawyer can discuss with you your legal rights as well as your prospect for obtaining compensation for any harm that you have suffered, although there is no guarantee of a recovery.
Sources: https://www.nbcnews.com/health/womens-health/women-sounded-alarm-essure-birth-control-device-now-fda-cracking-n865531
https://www.nbcnews.com/health/womens-health/women-sounded-alarm-essure-birth-control-device-now-fda-cracking-n865531
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