Essure Injury Attorneys in Boston
The most common complications patients have with Essure are the following but not limited to:
- Fetal death
- Perforation of organs
- Ectopic pregnancy
- Device breakage or migration
- Migration of the device can range from a vast variety of ways. The device itself could migrate out of the fallopian tubes by not taking hold and then find its way all the way to the uterus. In the event that the migration can or will cause damage, the resulting consequence can be an unwanted surgery or a hysterectomy.
As of July of 2018, Bayer announced that they would no longer market the Essure device and were recalling it completely with intended effect at the close of 2019. This comes after they had already halted the sale of Essure in every country besides the United States. Furthermore, this comes after well over 30,000 women have come forward stating their pain and suffering to what they believe is attributable to Essure. The FDA continues to monitor the status of Essure and over the next 5 years will continue to do annual reports on the device releasing the results to the public in September of each year through 2023.
Essure was initially brought into the market with PMA (pre-market approval), potentially limiting actions against the manufacturers, Bayer. However, In August of 2016, Judge Winifred Smith in California ruled that a group of women were no preempted under federal or state law from making claims against Bayer. Specifically, the Judge found that the failure-to-warn claims were potentially valid as Bayer failed to adequately warn the public of the serious side effects and/or the severe consequences of an Essure placement surgery. It is Bayer’s position that the benefits outweigh the risks.
Other Allegations Against Bayer:
- Failing to report and actively concealing adverse reports
- Failing to disclose a vast amount of medical device complaints
- A lack of training to doctors and representatives
- Faulty risk analysis over Essure
As a device, Essure is composed of two small metal coils. These metal coils consist of nickel, titanium, and stainless steel among other materials. While initially hailed as a viable alternative to other forms of birth control, the FDA soon began investigating complaints about Essure in 2015. Following their investigation, in 2017 the FDA required a ‘black box’ warning, the strictest label the FDA can give to be placed on the Essure device. In April of 2018, the FDA restricted sales of Essure to medical centers and physicians who agreed to adhere to a strict standard checklist with patients when it came to inserting Essure. While the FDA initially took the stance that Essure’s benefits outweighed the risks, after receiving over 16,000 complaints with injuries ranging from fatigue and heavy blood loss all the way to punctured organs, they stated the warning label on Essure must be updated.
While cases represent varying factors based on an individual’s circumstance, if you or a loved one were implanted with an Essure birth control device and the device caused a severe injury, please contact us to speak with an experienced Essure injury attorney at the Jeffrey Glassman Injury Lawyers and we will help you get the compensation you deserve.
Approved in 2002, Essure is a permanent birth control device for women originally manufactured by Conceptus, Inc., but in 2013 was purchased by Bayer AG and became a fully owned subsidiary of the German pharmaceutical company. Introduced into the market as an alternative to tubal ligation, Essure does not require an invasive surgical incision as instead it is inserted by a doctor through the vagina into the fallopian tubes. After 90 days, the patient would meet with the doctor to ensure that the device has taken hold properly. The goal is for scar tissue to build up overtime around the device, keeping sperm from reaching the eggs and as a result stopping the chance of conception.