Virginia Essure Injury Lawyers
Essure, A Dangerous Birth Control Device
Thousands of women have filed lawsuits against the drug company Bayer over the Essure birth control device. The contraceptive is linked to a wide range of side effects. Some women had a hysterectomy operation to remove the Essure device and repair internal organs. Essure is linked to deaths and the perforation of the uteris of users.
What is Essure?
More than half a million women in the United States use Essure for birth control. It’s a non-hormonal prescription-only form of permanent birth control. The device comprises of two flexible, stainless steel coils. It also contains polyethylene fibers and nickel titanium. The fibers encourage the surrounding tissue to attach to the contraceptive device. It creates a barrier of scar tissue that stops sperm from reaching the eggs. Doctors insert Essure into a patient’s fallopian tubes. It’s non-reversible. According to Bayer, it’s 100 percent effective in preventing pregnancy. The U.S. Food and Drug Administration (FDA) approved Essure in 2002. It was originally manufactured by Conceptus Inc., a company acquired by Bayer in 2013.
What Are the Side Effects of Essure?
A large number of side-effects have come to light during mass tort litigation against Bayer. They include:
- Additional Surgeries - Many women have reported having hysterectomies to remove the Essure device and repair their internal organs.
- Severe Pelvic Pain
- Serious Autoimmune Reactions - Weight gain, hair loss, rashes and chronic fatigue have been reported.
- Ectopic Pregnancy - This is a dangerous and potentially life-threatening condition;
- Migration - of the parts of the device into the body. Parts can be undetectable but can cause pain, bleeding, and other side effects.
- Tears or Perforation - of pelvic organs such as the colon on the uterus.
- Serious Migraine Headaches - and allergic reactions to Essure or parts of the device.
Complaints About Essure
An FDA report in September 2015, stated more than 5,000 complaints were received about Essure. The device is linked to more than 30 deaths. The FDA did not issue a recall but it issued new advice about Essure. It said women with a hypersensitivity to nickel should not use it. Women suffering from autoimmune disorders, chronic pelvic pain or those who had uterine surgery should not use the device. Women have joined online support groups to document their issues with Essure. A group on Facebook boasts more than 27,000 members. There is also a group called the “E-sisters.” In 2015, the group introduced a bipartisan bill to Congress calling for the removal of Essure from the market.
In September 2016, the FDA approved Bayer’s postmarket surveillance study plan for the device after considering its adverse side effects. Data gathered from the report will help the FDA make representations. Alarmingly, Bayer has until Sept 1, 2023, to submit its final report to the FDA. However, an interim report will be released in March 2017, states the Regulatory Affairs Professionals Society (RAPS). The main areas of study include chronic pelvic or abdominal pain, serious bleeding, the surgical removal of Essure, and allergic reactions to the device.
In 2016, the FDA said it will require a new "black box warning" label for the device. Critics say far too few studies about the side effects of Essure have been carried out to date.
On April 9, 2018, the FDA took the almost unprecedented step of restricting the sale of Essure. The device can only be sold to only doctors and healthcare facilities who use an FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”. The sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients and allow them the opportunity to sign it.
Lawsuits Against Bayer over Essure
In Aug 2016, a judge in California allowed a number of Essure birth control lawsuits to proceed against Bayer, despite the drug company seeking to get them dismissed. The ruling is likely to usher in lawsuits from thousands of other women who say the device left them with serious permanent injuries. Alameda County Judge Winifred Smith’s Aug. 2 ruling allowed the claims of 14 women to who say they were harmed by Essure to proceed. She rejected three motions by Bayer to have the cases thrown out. About 200 cases have been filed in California. Lawsuits are also moving forward in Illinois and Pennsylvania. Bayer argued that under federal preemption law, the plaintiffs should be barred from filing lawsuits. They claimed Bayer was not liable for injuries because Essure was approved by the Food and Drug Administration. More than 17,000 cases against Bayer were filed by May, 2018.
What To Do If You Have Been Hurt by an Essure Device
Many medical devices have caused harm to patients and led to thousands of lawsuits. Essure, like many other devices, was allowed on the market because of a “fast track’ process. We do not believe it was properly tested, and many more women could be harmed by the time detailed trials are carried out. Many contraceptives have proved to be harmful to women, including Mirena and Yaz and Yasmin.
Contact Our Experienced Essure Injury Lawyers
The medical device manufacturers continue to push these dangerous contraceptive products despite the overwhelming evidence of the harm they do to women. Cooper Hurley Injury Lawyers has helped women who have been harmed by medical devices. We will give you experienced representation and ensure your personal claim is properly handled among many others in the mass tort litigation. Time may be short to act in these cases. Call us at 757.455.0077 or toll free at 866-455-6657 for a free consultation.