Due to serious adverse health concerns, the U.S. Food and Drug Administration (FDA) has mandated that a “black box warning” be added immediately to all Essure packaging. The announcement was made Feb. 29 in response to the more than 5,000 grievances the FDA has received from women who have used the device.
Pharmaceutical giant Bayer, makers of Essure, have also been required by the FDA to include a Patient Decision Checklist to ensure that women are provided with and understand vital information about the product’s risks and benefits.
ESSURE AT A GLANCE
Designed to be a permanent form of birth control, Essure involves the insertion of two metal coils into a woman’s Fallopian tubes. After about three months, scar tissue formed around the coils acts as a barrier to prevent sperm from reaching the eggs, preventing conception.
BAYER FALLS SHORT IN RESPONSIBILITY TO COMMUNICATE
The FDA’s mandated packaging requirement is a specific response to lawsuit claims that Bayer deliberately misled consumers about the dangers of using Essure. While existing Essure labeling provides warnings of bleeding and pelvic pain just after the insertion procedure, many women have said that the problems never ceased and were so severe, surgery to remove the device was necessary.
The Patient Decision Checklist is intended to facilitate communication between physicians and their patients concerns of Essure use. It will emphasize the importance of an examination three months after the procedure to implant the device to make sure it is properly placed and that the scar tissue has formed.
Proper placement of the Essure coils is crucial because there have been complaints of the device actually migrating from the Fallopian tubes to other parts of their bodies, resulting in serious internal injuries.
GROWING OUTRAGE OVER ESSURE
Bayer has been in hot water over Essure ever since the product first received FDA approval in 2002. Consumer advocate Erin Brockovich has established an Essure website for education about the product and to provide a central location for Essure users to share their own stories.
About her site, Brockovich said, “It is a woman’s right to decide for herself if she wants a certain form of birth control but when they are NOT told of the devastating side effects, well that isn’t right.”
SYMPTOMS OF PROBLEMS FROM ESSURE
Below is a listing of just some symptoms that have been reported by women who diagnosed with having serious health issues related to Essure.
- Prolonged cramping
- Fallopian tube cysts
- Constant spotting
- Hot flashes
- Uterine infection
- Loss of libido
- Urinary tract infection
- Chronic pelvic pain
- Pain in the back, joints, chest breast, neck and spine
- Prolonged depression
You can read the full list of symptoms here. If you continue to experience these symptoms after your Essure procedure, we urge you to see your physician and consult with a personal injury attorney.
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