Essure is a permanent birth control system for women that is administered on prescription only. Manufactured by German pharmaceutical company, Bayer Healthcare, it was approved as a “high-risk” medical device in 2002.
Since then thousands of women have experienced frightening symptoms and ill effects from the device, and hundreds have filed personal injury lawsuits against Bayer. These claims allege that Bayer has been hiding evidence from the US FDA (Food & Drug Administration). More than 900 Essure-related lawsuits have been filed to date, but not one case has gone to court or been settled.
This might be about to change.
While Bayer has up to now kept the legal wolves at the door, a ruling by Judge Winifred Smith from Alameda County in California has the pharmaceutical giant worried. The judge ruled that the claims of 14 women were not expressly or impliedly preempted under federal or state law, effectively allowing them to progress to litigation.
How to file an Essure lawsuit against Bayer
Women who have suffered side effects from having the Essure inserted can file individual lawsuits against Bayer, as opposed to a class action suit. If you think you have a claim, contact a lawyer, preferably one with experience in Essure lawsuits or other similar defective medical devices.
Bayer is one of the largest pharmaceutical companies in the world, they have an army of high-powered lawyers and a legal war chest to rival a small country's GDP. They are no pushovers, which is why you need a strong, tough law firm with all the necessary resources and skills to take them on.
While your side effects may only have started a few years after insertion, you must hurry to file suit as statutes of limitation may apply. Wait too long and you may miss out on your opportunity to claim compensatory damages for your medical bills, loss of income, or any pain and suffering that you have gone through or are still going through.
The not-so-kosher history of Essure
When Bayer Healthcare first brought Essure to market, they touted it as a simple, safe and effective method of permanent birth control. It could be inserted without the need for surgery and was supposed to be the new ‘wonder device’ for female birth control. However, this has not been the case for thousands of women around the country who have suffered debilitating side effects from the device.
These side effects include:
- Chronic headaches and pelvic pain
- Colon Perforation
- Allergic reactions to the nickel used in the device
- Ectopic pregnancy risk
- Device movement
- A need for a hysterectomy following use of the device
A lawsuit has also been filed against Bayer claiming they violated the FDA conditional premarket approval in 2002. Bayer was obligated to notify the FDA about the more than 15,000 reports of side effects that they had received. The suit claims that their failure to do so in effect invalidates the FDA approval they received for their device. The suit claims this makes Essure adulterated.
Has Essure been recalled?
Not in the USA. Despite the thousands of complaints and lawsuits filed, the product continues to be legally available for sale. The FDA did tell the German drug company to conduct further safety studies in 2016. They also told Bayer that the product must be packaged with a "black box" label warning about the potential side effects. They are also obligated to add a checklist for doctors to discuss with their patients, making them aware of the possibility of side effects. Barely a slap on the wrist. And as for Bayer’s safety studies, well they might be ready in 2023, - if Bayer meets the deadline. Don’t hold your breath.
Brazil on the other hand has suspended the importing, distribution and marketing of Essure. The device was recalled, but it is unclear if this recall will involve removing the already implanted devices.
Complicating Things: New study proclaims Essure as “safe”
A recent study by a French company declared the Essure device safe. This seems rather disingenuous considering the thousands of complaints and some of the horrific stories of what some women have gone through. As mentioned above, Brazil has practically banned the device already.
In the meantime, thousands of women continue to suffer and thousand more are still choosing to have the device inserted. If you are considering using this device, we advise you to do your research thoroughly and know the risk that you are taking.
If you are suffering side effects from the Essure device, contact us, your local legal specialists and you may well have a case against Bayer. Even though the first case has not gone to court yet, it’s only a matter of time and Bayer could find themselves in a whirlwind of Essure lawsuits in the not too distant future.
Disclaimer: This blog is intended as general information purposes only, and is not a substitute for legal advice. Anyone with a legal problem should consult a lawyer immediately.