Essure is a birth control device used to prevent pregnancy on a permanent basis. It was approved by the FDA and introduced to the market in 2002, while manufacturing rights were still owned by Conceptus. Since then, and since Bayer acquired Conceptus and the right to manufacture Essure, many users have suffered serious medical complications after the implantation of their device.
Essure is implanted through the vagina in an outpatient procedure. It features two coils inserted into the fallopian tubes, which over time, cause scar tissue to form and prevent eggs from passing through the tubes. Essure is chosen by medical professionals and women when there is no desire to ever become pregnant but do not have the option of hysterectomy or other permanent procedure due to safety or inconvenience.
Despite its FDA approval, there is a great deal of evidence Essure puts women at risk for injuries related to the device, such as device migration that leads to damage in the user’s reproductive system or elsewhere in her body. There is also debate over how effective Essure is for preventing pregnancy, since many users have experienced ectopic pregnancies and various pregnancy-related complications.
According to KATU, a news station in Portland, Oregon, the FDA has required Bayer to conduct a study of 2000 patients comparing issues such as unplanned pregnancy and pelvic pain between patients getting Essure to those receiving traditional birth control surgeries (tube tying). FDA officials state they have reviewed more than 600 reports of women becoming pregnant after receiving Essure.
Essure users have also reported a range of symptoms ranging from mild to severe, including pain, weight fluctuation, menstrual irregularities, hemorrhaging, headaches, and issues related to device migration. There are some instances of allergic reactions to chemicals in the device, and many women have been forced to undergo hysterectomy surgeries to remove the device.
FDA Warns of Essure Risks
In response to the numerous reports, the FDA has issued warnings concerning Essure and many users have filed lawsuits in relation to their health complications. Nearly a dozen lawsuits have been filed against Bayer, Essure’s manufacturer, in relation to the injuries allegedly resulting from user of the device. Recently a California state court determined the lawsuits could move forward and there is a chance the cases could be heard in federal court.
Some of these cases were consolidated into a single case representing 14 women who claim their device left them with serious injuries that were far worse than any listed in information provided to them by their doctors and published by Essure. There are more than 200 additional lawsuits related to Essure throughout the California state and federal court system. Bayer lost its attempt to claim that because Essure was approved by the FDA, prior to Bayer owning the rights to Essure, it should not be held responsible for any injuries.
In addition to women claiming they were not properly warned of potential side effects, there might also be evidence that information submitted to the FDA for Essure approval was falsified.
Essure received approval through an FDA fast-track program that gave approval to Conceptus, the device’s original manufacturer. This approval was based on the commitment to studying Essure users for four to five years after implantation. That study was completed in 2007, but data was not published for eight years after.
Red flags were also raised when it was revealed that fewer than three quarters of the women implanted had been followed for the entire five years. Some women in the study even came forward admitting the information issued by Conceptus about their Essure use had been falsified.
As a result of those reports, the FDA investigated and found at least six cases of potential tampering, but determined it was “sporadic tampering” and did not show any pattern of intentional falsification. The FDA has since required a black box warning be placed on Essure boxes, but has yet to determine a complete ban on the devices is necessary.
Essure Lawsuits Include a Variety of Allegations
Lawsuits filed against Bayer currently include accusations of negligent misrepresentation, breach of express warranty, fraudulent representation, negligent manufacture, and negligent risk management. California lawsuits allege there was a failure to monitor and test the device, and that Bayer did not exercise reasonable care in its manufacturing and quality control. Women are also claiming their doctors were not properly trained and certified by Bayer to insert the device.
Time will tell how much blame juries place on Bayer, but many are concerned that in the meantime, women continue to be put at risk as Essure devices are implanted in new users.Show Sources