Essure is a Bayer Pharmaceuticals product that is a permanent birth control device for women. The device is implanted in women via a surgical procedure. Essure was considered a permanent birth control device. This means that it was not intended to be removed.
Over the past several years the FDA noticed a larger number of complications and adverse events around Essure. Some of those events according to the FDA website include, persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. In addition, some women have undergone invasive surgical procedures to remove the device. A failure on behalf of the Essure device has also lead to unintended pregnancies.
In 2018, the Food and Drug Administration required a black box warning on Essure products. The black box warning is the highest and most significant warning a pharmaceutical can have.
On July 20, 2018 Bayer Pharmaceuticals announced that the company would stop selling Essure, the companies birth control device in the United States. Bayer has claimed that the reason for the withdrawal is “inaccurate and misleading publicity”. Bayer has not specifically commented on the injuries or complications suffered by so many women. It is defending thousands and thousands of lawsuits surrounding injuries from the use of Essure.
Some women have been fighting to have the Essure device withdrawn from the market for more than five years. Those fights included rallies in front of the Food and Drug Administration building in Washington. Some of those women have also met with FDA officials about the complications and injuries which resulted from the use of Essure.
Recently, CNN ran a piece on how Bayer paid millions of dollars in consulting fees to thousands of doctors in regard to Essure. The payments have not been deemed to be illegal, but some have questioned the payments nonetheless. The full article can be read here. https://www.cnn.com/2018/07/27/health/essure-bayer-doctor-payments-eprise/index.html
Injuries From Essure
In addition to the above listed injuries, reported injuries from Essure include:
- Pelvic discomfort
- Vaginal bleeding
- Perforation of the fallopian tube
- Unintended pregnancy
- Allergic reactions
- Weight losses
- Hair loss
- Mood changes
- Device displacement
- Device malfunction
Recently, a Netflix documentary, “The Bleeding Edge” discussed the controversy surrounding the medical device industry and how the push for marketing and sales can lead to untested and dangerous products coming to market which in turn have caused significant harm to patients.
Free Legal Consultation
If you or someone you know would like to speak with one of our attorneys about an injury suffered from an Essure product, contact our New Jersey Essure Attorneys today. Our lawyers represent individuals who have suffered injury as a result from Essure products throughout the state. Our lawyers will meet with you and discuss all of your options. Call us today.