A device which contains a 4 cm, micro-insert with an expanding coil in which the inner coil is made of stainless steel, an outer coil made of nickel titanium and polyethylene fibres was found in 2002. The device was named Essure and the micro-inserts are inserted into the fallopian tubes and the coils will expand after releasing. As a result of the swelling made by the PET fibres, the scar-tissue blocks the tubes and will bring permanent fertilization. The company named Conceptus introduced this device in the year 2002. During that time, this implant was a breakthrough as it was considered to be the best to surgical sterilization for women. In the year 2013, Conceptus was bought by Bayer Healthcare Pharmaceuticals.
Essure Legal Challenges
In the year 2015, the FDA initiated an investigation on this Essure Lawsuit device with response to recall petition. The petition had stated that the company Conceptus, performed fraud during the clinical trials of this device, breached the conditions of FDA’s approval, and infringed many federal laws in manufacturing and marketing of this device.
As this product was brought to the market after FDA’s approval, Bayer is currently protected from product liability petitions of this device. But the court documents show that a lawsuit currently pending in US District Court in the Eastern District of Pennsylvania, asks to remove this protection for women. When the Court states that the conditional approval for this device is not valid anymore, many other users who are injured by this device will be able to file a lawsuit to claim compensation for the injuries caused. The lawsuits claims to have many legal actions taken against Bayer Healthcare Pharmaceuticals which includes designing of a product with faults, inattention, failed to issue warning on health risks, violation of express warranty, fraudulence, not representing the safety and effectiveness of the device, not training the doctors on how to use the device.