San Diego, CA May 22, 2015– Major news for victims of the Essure implant!
A Florida woman, the first to file a pending lawsuit against Bayer for negligence and breach of express warranties concerning the Essure birth control, has led the way for possible litigation by others who have been injured by this implant.
A motion for judgement on the pleadings has been filed for the case and depending on the outcome, there could be some real changes made to the Essure implant. If the court rules that the conditional approval for Essure is no longer valid, the thousands of other women suffering from this implant may be able to have their voices heard.
Inexperienced Doctors install the Essure Device
Heather Walsh, a victim of Essure, obtained the implant from a doctor who did not receive any training from Bayer on how to insert the device. She was hospitalized for severe pain and fainting spells almost two years after having the implant. Tests revealed that the implant had migrated in her body and lodged behind her colon. In order to remove the device, Walsh had a complete hysterectomy and other surgeries.
Walsh isn’t the only woman going through this ordeal. There have been more than 4,000 reports to the FDA of serious complications from the implant. There is even one report of a woman dying during surgery to remove the implant in January of 2015.
Angie Firmalino had the implant in 2009, and after two years, it was removed due to the coils breaking and migrating to her uterus. She also required a hysterectomy, and created a Facebook page to warn women of the risks of Essure.
Medical Device Act
Essure has been in use since the FDA issued a Conditional Premarket Approval in 2002, but Walsh is the first to bring forth an Essure lawsuit against Bayer in 2014. The Medical Device Act contains a preemption provision that prevents lawsuits for injuries caused by medical device manufacturers for devices that received pre-market approval from the FDA.
In her case, Walsh claims that her negligence and breach of express warranties are not preempted by the MDA because “the cause of action has nothing to do with the product itself, but rather Bayer’s negligence.” The manufacturer allowed untrained physicians to use specific equipment to erroneously implant the device.
FDA Violations
According to Walsh, the FDA and Department of Health cited Bayer for its failure to report results from trial studies. This includes failure rates that they “actively concealed” resulting from Essure implantations. The company was also qualified to alert the FDA when it took over Essure from the previous company of Conceptus.
Essure Pushed on Doctors Without Training
The complaint alleges that Bayer was neglectful in its distribution plan, failing to provide training to doctors on the insertion method of the implant. Bayer provided the doctors with specific equipment for the implant, even though they were inexperienced in their training. In return for this equipment, the doctors were required to purchase at least two Essure kits per month.
If you, or a loved one, had the Essure implant and suffered adverse side effects, you may be entitled to compensatory damages. Don’t let the manufacturer practice profit over people. Read more about Essure here: https://www.nationalinjuryhelp.com/defective-products/essure-contraceptive-implant-lawsuit/
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