In July of 2018 Bayer announced that it would discontinue the sale of Essure medical devices by December 31, 2018. If you have suffered side effects associated with an Essure implant, talk to an attorney at Schneider Hammers today as you may be eligible for compensations.
Marketed as a “permanent contraceptive”, Essure is a non-surgical sterilization device consisting of two metal coils that are inserted through the uterus and placed in the fallopian tubes causing scar tissue to form, and permanently closing the fallopian tubes. While most prescription drugs and medical devices come with risks for adverse reactions, more than 16,000 lawsuits have been filed over Essure, “with women citing complications like migraines, hair loss, organ perforation and even unintended or dangerous pregnancies,” according to ConsumerSafety.org. In 2017 alone, nearly 12,000 adverse events were reported to the FDA regarding Essure.
At Schneider Hammers, we’re committed to helping injured victims get their lives back on track. A recently released Netflix documentary gives insight into the process of medical device approval that we, as a firm, are trying to change. The Bleeding Edge examines the FDA and the approval process that medical devices undergo before being released.
In 1976, the FDA began regulating approvals for the manufacture of medical devices. Medical devices on the market before 1976 were grandfathered in and went untested by the administration. Through the documentary, the viewer learns of two device approval processes, Premarket Approval (PMA) and Premarket Notification (PMN), called the 510(K) process. According to the FDA’s website “PMA is the most stringent type of device marketing application required by FDA.” To be approved under PMA, the manufacturer must test the medical device on humans, compile the scientific data, and present their findings to the FDA scientists who will decide if the device is safe and effective.
The main concern of critics in The Bleeding Edge is the 510(K) process which allows the release of devices without much clinical testing. Even though new devices are expected to go through premarket approval, some medical companies argue that, with the rate of innovation, “it’s too expensive to send each device through massive amounts of clinical testing.” When manufacturers apply under the 510(K) process, they only need to demonstrate the device is “substantially equivalent” to a device already on the market. Even if the prior device has been recalled, it will not affect the approval of the new device. 98% of devices on the market today were approved under the 510(K) process.
“We assume the FDA has the data they need to crack down on manufacturers that have bad devices or to recall a product, and they don’t have that.” – Madris Thomas, Former FDA Analyst, CEO, Device Events
The Bleeding Edge highlights how often former FDA officials are later hired by medical device companies, and conversely, how often business executives get cushy government positions. An anonymous sales representative from a medical device company lays out the financial incentives used to encourage surgeons to use the company’s products, in saying, “it’s gotten worse over time because of greed”. In 2016 alone, medical companies paid doctors more than $2 billion in grants and incentives for consulting. “The Bleeding Edge isn’t an anti-medical film; indeed, the filmmakers aren’t shouting ’Fire’ in a crowded theater. For them and their subjects, the inferno has already occurred. Now they’re sweeping up the ashes, and warning of new blazes sure to come.”
If you or someone you know has suffered harm in connection with the Essure contraceptive device, please call Schneider Hammers and speak with an Atlanta Essure lawyer today. Because each state has different statute of limitations, time is of the essence in getting the help you need. Our seasoned legal team may be able to help you recover compensation for the losses you have sustained through the use of the device, including pain and suffering, past and future medical bills, lost wages, and more. We have handled countless dangerous medical device cases in our years of experience and are not afraid to take your case to court to obtain the best results possible.