While undergoing a permanent birth control procedure, you’re likely expecting a safe and effective means of preventing pregnancy. Permanent fallopian tube implants, like Essure, may seem like a safer and easier method than tubal ligation surgery (i.e. getting your “tubes tied”); however, it’s the unfortunate fact that thousands of women have suffered serious consequences as a result of these implants.
Because of these issues, over 16,000 lawsuits have been filed against Bayer for the side effects and issues associated with Essure, ranging from chronic pelvic pain to death. Our Omaha Essure birth control lawyers are keeping up-to-date on the current information that is being released by Bayer and the U.S. Food and Drug Administration (FDA), so we can fight for our clients who deserve justice in this matter.
If you believe you’ve suffered complications from the Essure birth control implant and are thinking about taking legal action, it’s important to understand the history of the device, the complications thousands of women have been experiencing, and what your rights are as a victim. Keep reading to learn more.
History of Essure
Essure is considered a hysteroscopic sterilization procedure. It allows for sterilization without an incision. If a woman chooses to undergo the procedure to have the device implanted, a mental device, consisting of a stainless steel inner coil and an expanding nickel titanium outer coil, is implanted into her fallopian tubes.
Essure was approved by the FDA in 2002. At the time it was marketed by Conceptus, Incorporated. Bayer acquired Conceptus, Incorporated and Essure in 2013. The device was initially subjected to the FDA’s most stringent review, using the pre-market approval (PMA) process. As a condition of the PMA, Conceptus had to conduct to post-approval studies that would gather five years of follow-up information on participating patients and evaluate the procedural success of newly trained physicians.
As a result of the PMA, the FDA has forced Bayer to make multiple label changes over the years to the device to ensure possible participants understand the risks. These label changes include:
- 2011: a nickel sensitivity warning
- 2012: an update including the results of the five-year follow-up
- 2013: a chronic pain and device migration warning
- 2016: a boxed warning and patient decision checklist
- 2018: a restriction on sale and distribution
As of July 2018, Bayer has announced Essure birth control will no longer be sold in the United States by the end of the year. While thousands of women have experienced side effects, Bayer is claiming to be halting the sale because of a decline in sales in recent years. They attribute this decline to women seeking impermanent birth control options and misleading publicity.
Essure Complications and Side Effects
The complications and side effects commonly associated with Essure are often a result of the nickel-titanium alloys causing an allergic reaction. Symptoms of the reaction include rash, itching, and hives.
In addition to the allergic reaction, some women may experience the following complications and side effects after having the Essure device implanted:
- Additional surgeries to remove the device or repair internal organs
- Autoimmune reactions including fatigue, rashes, and weight gain
- Brain fog
- Chronic pelvic pain
- Device breakage, expulsion, or migration
- Ectopic pregnancy
- Fetal death
- Hair loss
- Menstrual problems
- Migraine headaches
- Perforation of the uterus, color, or another organ
- Severe pain
- Unintended or unwanted pregnancy
Many of these side effects can result in severe, and sometimes life-threatening, consequences. If you currently use or have used Essure, it’s important to understand your medical options and legal rights.
If you’ve experienced side effects related to Essure or if you’re concerned about possible complications, you may be wondering what your options are to remove the device.
According to the device’s label, the procedure is permanent and generally cannot be reversed. But while it’s unlikely fertility can be restored, the device itself can be removed surgically; however, that comes with its own set of complications. If the device breaks apart during surgery or perforates an organ, additional surgeries are likely.
The removal procedure can cost thousands of dollars. A successful procedure typically lasts 30 to 45 minutes and is conducted under general anesthesia. Openings are made in the fallopian tubes, the device is removed, and the fallopian tubes are sealed.
Filing a Lawsuit with an Omaha Essure Birth Control Lawyer
While it’s rare for a class action suit to be filed against a medical device, this does not mean you’re out of options. You have the right to take individual legal action, like the other thousands of women who have sustained injuries and complications because of this dangerous device.
You may be able to file an Ensure lawsuit against Bayer if you’ve had an Essure birth control device implanted and the device caused any of the severe complications listed above. Many individuals in similar situations are seeking economic damages for the cost of medical care to treat their symptoms and complications due to the device’s malfunction. Some are also seeking noneconomic damages related to pain and suffering, as well as punitive damages to punish Bayer for the unsafe device.
To learn more about your rights and the possibility of compensation, our Omaha Essure birth control lawyer can help. We’ll review your case for free and explain what your options are. Contact us today.