Birth Control System Linked To Serious Side Effects
Essure Permanent Birth Control System is a prescription-only form of permanent and non-reversible birth control marketed as an alternative to female sterilization procedures like tubal ligation (tying tubes). The United States Food and Drug Administration (FDA) approved the product in 2002, and in 2013 Bayer purchased Conceptus, the company that originally made the device, for $1.1 billion. According to reports, approximately 750,000 women have had this device implanted in order to prevent pregnancy.
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Bayer No Longer Selling Essure Implants
On July 20, 2018, Bayer announced that it will discontinue sales of this product by the beginning of 2019. After spending years combating thousands of lawsuits from women severely injured by this implant, the multinational pharmaceutical and life sciences company will finally take Essure off the shelves. This announcement follows the Food and Drug Administration’s (FDA) requirement for Bayer to begin fully informing women about the potential risks they could face when using this product. During that meeting with Bayer, the FDA reported that it had received an estimated 27,000 reports from women who suffered adverse effects because of Essure between 2002 and 2017. The true number could be much closer to 30,000 women though, according to at least one former FDA official
“With side effects ranging from hair loss and tooth loss to chronic pain, severe bleeding, miscarriages and even death, the benefit risk profile touted by Bayer simply didn’t jibe with the data that was pouring into the F.D.A. from both patients and physicians,” former FDA official, Madris Tomes, who now runs a company that analyzes adverse event data said.
In order to properly warn women about the risks of using Essure, the FDA ordered Bayer to put a black box warning on its product that would include a note that it was at risk of migrating into users’ abdomens and pelvic cavities, something that would require surgery to properly treat.
How Does Essure Work?
The device is inserted using a thin, disposable metal catheter that contains the compressed device coils. They are inserted through the vagina and positioned at the entrance of each fallopian tube before insertion. Once inserted, the coils expand and anchor themselves in the tube’s walls.
In the three months following this procedure, scar tissue slowly builds up around the coils and eventually blocks the fallopian tubes. In some cases, the tissue may take longer than three months to build up, so a follow-up visit is required to confirm that the tubes are completely sealed off.
Dangerous Side Effects Associated With Essure
While Bayer continued to market Essure after merging with the original manufacturer, thousands of women have come forward and asserted that the device caused them to suffer from a number of devastating side effects, including:
- Severe pelvic pain
- Perforated organs
- Autoimmune diseases
- Unintended weight loss
- Allergic reactions to nickel
- Migraine headaches
- Abnormal menstrual bleeding
- Device displacement
- Device breakage
These victims claim that their problems were ignored by both the FDA and by their doctors and that Bayer failed to properly warn them of these negative side effects. Some are turning to the legal system to secure compensation for lost quality of life and to cover the medical bills that piled up in order to treat their symptoms, and some are filing lawsuits in order to raise public awareness and protect other women from this product.
Did You Suffer These Serious Side Effects?
If you suffered any of these serious side effects associated with Essure, you may be able to file a lawsuit in order to secure compensation to cover your medical bills and any other damages you may have incurred. Our drug injury lawyers at Bailey Cowan Heckaman PLLC have dedicated their careers to providing injured victims with the legal representation they need to secure the compensation they deserve. Give us a call at (888) 367-7160 to discuss your case with one of our lawyers, or fill out our online form to request a free case consultation today.