Essure® is a non-surgical, non-hormonal permanent birth control for women. Originally developed by a company called Conceptus, it was later brought by Bayer Healthcare in 2013.
Since its FDA approval in 2002, Essure® has been implanted in over 750,000 women.
It is designed to cause severe inflammation, blocking the fallopian entirely and thus preventing pregnancy. The inflammation results in scar tissue that permanently blocks fertilization in women.
Bayer has touted the safety and effectiveness of its product, saying complications are rare and it is the only non-surgical permanent birth control device, with a 99% effective rate at preventing pregnancy. However, the patients and their complications speak for themselves.
Complications and Side Effects
As of September 2015, the FDA had received over 10,000 reports of serious complications that occurred from using Essure®. Women have reported serious, permanent injuries as a result of Essure®, including autoimmune diseases, organ perforation and severe pain.
Women who have used Essure® for birth control have also reported the following side effects:
- Device breakage
- Malposition of the device
- Abdominal pain
- Allergic reactions
- Excessive bleeding
- Heavy and/or irregular menstruation
- Organ perforation
- Weight fluctuations
- Pelvic pain
- Ectopic pregnancy
For many women who experience complications after the device has been implanted, it is due to a nickel allergy. While the FDA originally advised doctors to test patients for a nickel allergy before implanting the device, they removed that recommendation after being asked by Conceptus to do so. Some estimate that up to 12% of women are allergic to nickel. An allergic reaction to nickel may cause contact dermatitis as well as dry patches of blistery skin. Other signs of an allergic reaction may include:
Essure Class Action Lawsuit
Originally, women who suffered from the use of the Essure® birth control device were told they could not sue for damages due to a legal principle called federal preemption. In broad terms, federal preemption means that federal law trumps state laws and regulations.
With regards to this issue, the Supreme Court ruled in 2008 that the preemption provision in the federal Medical Device Act prevents patients who have been injured from filing claims against medical devices that have received premarket approval from the FDA. Because of this ruling, a judge must first invalidate the premarket approval of the Essure® device before victims can seek compensation from Bayer.
Victims have sued to have the premarket approval invalidated based on claims that Bayer mislead the FDA and failed to report problems with the device that they were aware of. In the Supreme Court ruling mentioned above, the justices also stated that once a device received premarket approval, it needed to be manufactured with almost no deviations from the specifics used in the approval process.
As part of the approval process, the FDA granted Bayer’s device a “conditional approval”. This meant that they had to comply with certain conditions in order to manufacture and market it. One of those conditions was that Bayer must alert the FDA immediately if it received information that suggested the device may have caused serious harm. Additionally, Bayer was required to provide safety and effectiveness information to its patients that was “truthful, accurate and not misleading.”
According to the lawsuit, Bayer failed to uphold the conditions that were imposed on them in multiple ways, including:
- Incorrectly using non-conforming materials in the manufacturing of the device
- Manufacturing the device at an unlicensed facility
- Failing to report knowledge of perforations that occurred due to the device
Currently, there are a number of lawsuits against Bayer seeking compensation for a variety of legal actions, including:
- Designing a faulty product
- Breach of warranty
- Failure to warn the public about health risks
- Willfully concealing the dangers of the product
- Misrepresenting the safety and effectiveness of the product
- Failing to properly train doctors on how to use the product
This past August 2016, a California judge ruled that a number of lawsuits against Bayer can move forward. Cases in Pennsylvania and Illinois are also moving forward, potentially opening the door for thousands of victims to seek damages.
In March 2016, the FDA ruled it would require Bayer to add a black box warning to Essure® as well as require additional safety studies to be conducted. The black box warning will notify potential patients that the device has been linked to adverse reactions including “perforation of the uterus and or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain and allergy of hypersensitivity reactions.”
It remains to be seen if Bayer will ultimately be held responsible for these complications. The information provided here is meant to be informative and does not constitute medical or legal advice in any way. If you are experiencing concerning symptoms or are considering the Essure® device, be sure to speak with a medical profession for proper diagnosis and recommendations.