If you are one of the more than 750,000 U.S. women who have had the Essure Permanent Birth Control System implanted in their body, you should be aware of the serious complications it may cause. You also may be able to seek compensation for any injuries related to the device.
The tiny, spring-like, Essure birth control device sold by the Bayer Corporation -- approved by the U.S. Food and Drug Administration (FDA) in 2002 -- is inserted into a patient's fallopian tubes, where it creates a barrier and prevents pregnancy. The device was widely considered safe upon its release, but thousands of patients have reported perforated fallopian tubes, severe abdominal pain, unwanted pregnancies, and even the need for hysterectomies. Several patients have reportedly died from complications caused by the device.
Despite these and other reported Essure birth control issues, the product remains on the market. There have been a few lawsuits filed against Bayer for its Essure device, including claims of failure to warn and negligent misrepresentation. However, because of the preemption of state tort laws by the FDA approval process, many of the patients' claims have not been allowed to move forward. Below are answers to some of the most frequently asked questions about Essure birth control issues.
Q: What is Essure and how does it prevent pregnancy?
Essure is a permanent, non-hormonal birth control device consisting of coils made of stainless steel, nickel-titanium, and polyethylene. It is inserted into the fallopian tubes through the vagina in an office procedure that requires no general anesthesia, making it an attractive alternative to tubal ligation ("tying one's tubes") and other forms of permanent birth control.
After insertion, the coils expand against the walls of the fallopian tubes, causing the build-up of scar tissue and blocking access to and from the ovaries. While the ovaries continue to release eggs on a regular cycle, they cannot pass through the fallopian tubes and into the uterus, thereby preventing conception.
Q: What serious health complications have been associated with Essure birth control?
More than 5,000 women have reported serious side effects from the use of Essure, ranging from abdominal cramps and vomiting to perforation of the fallopian tubes or uterus and device migration. Since the device is intended to be permanent, removal is not always an option and some patients have had to have hysterectomies and other invasive procedures to correct some of the more serious complications. Some of these interventions have caused additional complications, such as infections.
The FDA received 9,900 reports related to Essure birth control issues. The most common side effects were abdominal pain, menstrual irregularities, headache, fatigue, and weight fluctuations. Other reported problems include allergies to nickel, migration (movement) of the device, breakage of the device, malposition of the device, and as many as 631 reports of pregnancies.
Q: Have there been successful lawsuits for injuries caused by Essure?
None of the claims against Bayer for Essure have been adjudicated (as of May 2016).
Q: When was Bayer first sued for problems related to its Essure birth control device?
The first lawsuit against Bayer for its Essure birth control device was filed by Heather Walsh in 2013. According to Walsh's claim, one of the coiled devices was lodged in her colon. As a result, she underwent a hysterectomy and a separate procedure to remove the coil from her colon. She claims she suffered extreme and prolonged pain and autoimmune disorders as a result. She claimed that Bayer failed to properly train doctors or warn her about the possible complications.
Q: What did the FDA know about the potential Essure birth control issues, and when?
Essure was approved in 2002 through the FDA's pre-market approval process, which requires proof that the manufacturer has put the device (or drug) through particularly rigorous testing. In exchange, the manufacturer is shielded from liability (federal preemption of state torts). Plaintiffs claim irregularities in the process and even deliberate manipulation of clinical trial results, suggesting Bayer violated the terms of the pre-market approval process.
The FDA convened an advisory committee in September 2015 to determine the safety and effectiveness of Essure. While the agency didn't pull Essure from the market, it ordered Bayer to conduct more studies about its risks and also required additional warnings and product labeling.
Q: So is Bayer shielded from liability for its Essure birth control issues?
Not entirely. A judge in the U.S. District Court of Pennsylvania ruled in March 2016 that five plaintiffs (including Walsh) may move ahead with two of their seven claims against Bayer -- negligent misrepresentation and failure to warn.
Q: What should I do if I have suffered injuries or pregnancy after having an Essure device implanted?
If you haven't sought out medical attention for your Essure birth control issues, do so immediately. If you'd like to explore your legal options, including learning more about the strength of your claim, contact an experienced drugs and medical devices attorney near you today. An attorney will be able to discuss the specifics of your claim with you and advise you about your legal options.
Contact a qualified product liability attorney to make sure your rights are protected.