Women across America are being harmed by Essure birth control injuries caused by the defective contraceptive implant. Victims need a knowledgeable injury attorney or defective medical device lawyer to protect their legal rights with an Essure lawsuit.
Jim Adler & Associates’ experienced injury lawyers in Houston, Dallas, San Antonio and Channelview can fight for your legal rights if you have suffered an Essure birth control injury.
Harmful Essure side effects can include:
Since its approval by the U.S. Food and Drug Administration (FDA) as a contraceptive device in 2002, the Essure Permanent Birth Control System has been used by almost one million American women to prevent pregnancy.
Essure is a 4-centimeter micro-insert that’s implanted in the fallopian tubes to prevent pregnancy by triggering severe inflammation that can completely and permanently block the tubes. This happens when the implanted micro-inserts expand and anchor in the tubes.
The expanding coil is made of a stainless steel inner coil, a nickel titanium expanding outer coil and polyethylene (PET) fibers. These fibers create the inflammation, causing scar tissue to form over the coils and prevent fertilization. The process takes around 90 days.
Beyond the harmful Essure side effects listed above, a major problem is that one in eight women are allergic to the nickel in the device — nickel which can cause severe pain. Also, Essure is very hard for many physicians to implant successfully, sometimes leading to repeated implants.
In 2013, pharmaceutical giant Bayer purchased Conceptus, Essure’s creator. Then Bayer spent millions of dollars on ads marketing Essure as the “only non-surgical, permanent birth control available.” In doing so, Bayer evaded the product’s significant defects.
Thousands of American women have suffered from Essure implants. Indeed, at least 32,000 women have reported adverse Essure events to Bayer, and 10,000 have made Essure complaints to the FDA. Their injuries have led to around 1,000 Essure injury lawsuits so far against Bayer for its negligence in making, marketing and selling the dangerous product.
Bayer has countered that it’s protected by “federal preemption” provided by the 1976 Medical Device Amendments Act. That means courts cannot enforce state laws on medical devices which have had premarket approval (PMA) by federal agency the FDA.
However, courts recently have begun disregarding federal preemption as an excuse for Bayer not to pay its victims of Essure injuries. Some courts have held that by state law, medical device claims are valid against PMA devices when the state law’s restrictions are the same as corresponding FDA restrictions.
Thus, Essure birth control lawsuits are proceeding.
Also, Essure lawsuits are contending that Bayer’s premarket “conditional” approval of Essure by the FDA is invalid, due to Bayer’s many failures in living up to the FDA’s conditions.
Such conditions meant Bayer was required to alert the FDA about any information it received which reasonably suggested Essure might cause serious injuries. Bayer did not do this. In fact, Bayer hid the fact that women’s bodies suffered perforations because of Essure.
The FDA also required Bayer to be “truthful, accurate and not misleading” about Essure’s safety and effectiveness, which Bayer also failed to do. Bayer even used non-conforming materials while making Essure at an unlicensed facility, and it gave physicians financial incentives to persuade patients to use the device.
Bayer’s clear non-compliance with the FDA’s conditions — and its concealment of that — is being used in court to strike down Bayer’s claim of federal preemption and to allow women to sue Bayer for their Essure injury damages.
If you’ve suffered Essure side effects injuries, get an Essure lawsuit attorney from among the discrete and experienced injury lawyers at Jim Adler & Associates. Contact us today for a free and private legal review of your case — a confidential review which comes at no obligation to you.
You may be legally entitled to substantial financial compensation for your Essure birth control injury losses. That may mean payments for your:
You should not have to suffer these losses when Bayer was responsible for your Essure injury. Contact us today, and let us help you to seek and gain justice.