Please be advised that O’Connor, Acciani & Levy are no longer accepting cases for Essure Birth Control.
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. Our Cincinnati Essure birth control lawyers 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
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.
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
- 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?
