On July 20, 2018, Bayer announced it will stop selling or distributing Essure birth control devices in the U.S. on December 31, 2018.
This decision comes just three months after the U.S. Food and Drug Administration (FDA) threatened to impose criminal and civil penalties if Bayer did not comply with a restriction on the sale of these devices. The FDA mandated that Bayer could only sell the product to providers who required patients to sign a document stating they were informed about the risks and benefits.
Thousands of women who received these implants have suffered serious side effects, including chronic pain, damage to the uterus and fallopian tubes, ectopic pregnancy, and migration of the device into the pelvis or abdomen. There have been nearly 27,000 reports to the FDA about these and other side effects.
Bayer is facing thousands of Essure lawsuits from women who were implanted with these devices and suffered serious injuries and side effects. While Bayer’s decision to end sales of Essure devices ensures women will be protected from this defective product from this point forward, the countless women who did undergo an Essure procedure may have the right to take legal action against Bayer.
Our dedicated defective medical device attorneys at O’Connor, Acciani and Levy are ready to review claims on behalf of victims who developed serious health issues and complications after being implanted with the Essure device. We offer a free, no obligation legal consultation and do not charge for our services unless you receive compensation.
HOW DOES ESSURE WORK?
Essure is a small and flexible coil insert made from titanium alloy and nickel. During an Essure procedure, one coil is placed into each fallopian tube. The tip of each insert remains visible, so a doctor can confirm the accuracy of the implanted device. Over the course of three months, the body forms scar tissue around the inserts, creating a natural barrier to prevent pregnancy.
The advantage of this device compared to other permanent forms of birth control is that it is a non-surgical procedure. This means doctors do not need to make an incision to implant these birth control devices.
ESSURE SIDE EFFECTS
Following an Essure procedure, many women have reported adverse side effects. These have included short-term effects such as abdominal pain, bleeding, cramping, fatigue and weight fluctuation. However, many women have suffered serious health complications, including:
- Organ perforation
- Pain during intercourse
- Unintended or ectopic pregnancy
- Heavy or irregular menstruation
- Device migration or breakage
- Chronic abdominal or pelvic pain
There have also been 40 deaths attributed to Essure birth control devices, including 10 reports on the deaths of eight adults, 23 reports related to pregnancy loss, four reports of a death of an infant after live birth, two reports of ectopic pregnancies and one report of a death that may have been before or after birth.
If you suffered serious side effects after being implanted with an Essure birth control device, you may have legal options. Contact the defective medical device lawyers at our firm for a free legal consultation. We may be able to pursue fair compensation through an Essure lawsuit.
FDA WARNINGS ABOUT ESSURE SIDE EFFECTS
Since it hit the market in 2002, Essure was the first and only FDA-approved non-incisional permanent birth control product on the market. Bayer has continued to say these devices are safe and effective, repeatedly denying that the implant is dangerous or causes injury.
However, the FDA has received tens of thousands of reports of adverse events linked to these products. That is why the FDA has reviewed the safety of these devices numerous times in the past several years:
- In 2011, the FDA approved a label change warning about the potential for allergic reactions to the nickel in these devices.
- Another label change was issued in 2013 warning about the risks of chronic pain and device migration after an Essure implant.
- In 2016, the FDA added a black box warning on the product package. A black box warning is the strongest warning the FDA puts out and it notifies patients and health care providers about serious side effects. Essure’s black box warning said patients could suffer injuries, such as perforation of the uterus and fallopian tubes and device migration requiring surgical removal.
- In February 2018, the FDA commissioner met with women who suffered adverse reactions to the product.
- Concerned that women were not being properly educated on Essure’s risks, the FDA in April 2018 decided to restrict the sale of the device. The FDA order required all health care providers to inform patients of complications associated with the device. This included reviewing a brochure with the patient that covered the risks and benefits of the implant. The patient and his or her doctor was required to sign it.
The attorneys at O’Connor, Acciani & Levy can review your situation in a free legal consultation. We know how devastating the injuries from defective products can be, and that is why we are committed to fighting for your rights and pursuing just compensation.
AM I ENTITLED TO FILE AN ESSURE LAWSUIT?
Thousands of Essure lawsuits have been filed against Bayer by women who have reported severe and permanent injuries or illnesses. These lawsuits make various allegations against the company, including:
- Failing to ensure doctors who recommended this product were qualified to do so
- Failing to report side effects and taking steps to conceal this information
- Failing to properly train doctors about safe use of this product
If you or a loved one has suffered severe illness or injury after being implanted by an Essure device, you may be entitled to file a lawsuit against Bayer.
To determine if you are entitled to file an Essure lawsuit, our lawyers will review several factors and attempt to answer various questions:
- Was the Essure device defective?
- Was the Essure device known to be unreasonably dangerous?
- Did Bayer fail to comply with federal state laws?
- Did Bayer know of Essure’s side effects and fail to provide proper warnings?
- Did negligence play a part in your injury or illness?
Any woman implanted by the device who has experienced adverse side effects including chronic pain, irregular menstruation, ectopic pregnancy, device migration or preformation to the uterus, fallopian tubes or colon may be entitled to file a lawsuit.
CONTACT OUR SKILLED CLASS ACTION ATTORNEYS
To learn more about your legal rights, contact a skilled class action attorney at O’Connor, Acciani and Levy who can help hold Bayer accountable for their actions and recover the compensation you deserve.
We are here to help victims impacted by this dangerous and defective medical device. Our team of lawyers will provide you with a free, no obligation legal consultation to review your claim and determine whether your long-term injuries are related to having an Essure device implanted.
At our firm, we understand the difficulties caused by such a device and the emotional and financial struggles that it causes as a result. We work on a contingency basis which means there are no upfront legal costs or fees to worry about. Let us help you obtain the maximum compensation you are entitled.