The Essure Permanent Birth Control System is a non-hormonal permanent birth control procedure that creates a natural barrier against pregnancy. The way it works is a soft, flexible insert is placed into a woman's fallopian tubes. Over about three months, a natural barrier is formed around the inserts. Bayer, who sells Essure, is marketing that this procedure can be done in 10 minutes, usually in doctor's office. When you compare this to an invasive procedure like a hysterectomy, it is an easy sell for many women.
This artificial barrier keeps sperm at bay from the woman's eggs and prevents conception. After three months, a doctor administers a confirmation test to see if the inserts were placed correctly and the fallopian tubes are blocked appropriately. Bayer says that this is a nearly 100% effective form of birth control.Side Effects with Essure
The FDA received thousands of adverse event reports from women on Essure. In massive numbers, women were complaining that the device has caused them severe injuries. Specifically, they have claimed the following symptoms:
- autoimmune diseases
- pelvic, arm, leg and back pain
- perforated organs
- burning sensation
- abdominal pain
One way our lawyers get a feel for which drugs and medical devices are hurting people and should be recalled is: taking the pulse of patients online. There is a massive movement on Facebook with a group call Essure Problems that has nearly 10,000 likes. Women are pretty private about their birth control. But when this many women are standing up; it tells you a lot about the birth control.How Bayer Has Responded to Concerns
Bayer got involved with Essure when it bought Conceptus for over $1 billion, three years ago. Many doctors now say that more research needs to be done to establish what, if any, relationship exists between the device and the problems some patients have experienced.
The British Medical Journal reports that Essure users have experienced pain, allergic reactions, and complications due to the device which has caused these women to have surgery. These women were ten times more likely to need surgery, within a year, than women who had their tubes tied.
But Bayer is standing by its new purchase. Why would Bayer stand behind Essure in light of these concerns? When you are talking about drug and medical device companies, most questions end with a single word answer: profit.
Arguably, Bayer has been acting suspiciously. Bayer has been cited for:
- failing to report and actively concealing eight perforations, which occurred as a result of Essure which makes you wonder what else they have been hiding
- using non-conforming materials in the making of the device;
- manufacturing Essure at an unlicensed facility and without a license to do so.
Bayer has also had all sorts of problems with Essure's conditional Premarket Approval ("CPMA") which later became invalid because Bayer did not comply with all of its obligations, including reporting problems women have had with the device.
Does this mean that Bayer is knowingly standing behind a defective device that should not be on the market? No. But where there is smoke, there is often fire and Bayer certainly has financial incentives to defend Essure, which has already been sold to 750,000 women.
If Bayer's mistakes with Essure at some point lead to a class action settlement, no one will be surprised; including Bayer's shareholders - who have just gotten past settlements related to its birth control drug Yaz. One notable feature of the Yaz cases is the Bayer's Mirena IUD is also the subject of many ongoing lawsuits.
How can all of these Bayer birth control products end in disaster? Does Bayer just not know what it is doing? Or does it know exactly what it is doing and these lawsuits just an accepted part of doing business? When Bayer bought Conceptus, there were already Essure lawsuits percolating. You have to wonder how important these lawsuits are when you are a company like Bayer that is bringing in around $46 billion a year in revenues. Can Bayer make more money recalling Essure or just paying the class action settlements like it did with the Yaz cases?What is Next for Essure?
There was a big FDA meeting in October 2015 to discuss Essure, the growing concerns of women, and the best path for public safety moving forward. Bayer was wildly criticized at that FDA meeting for not providing the data to give the FDA -- and women and their doctors -- the information to make the right call. Will the FDA act? Anyone who understands the history of the FDA knows that it is almost invariably behind the curve. So it is reasonable to expect lawsuits, litigation and settlements before the FDA finally catches up.
There is also a bill in the House of Representatives ordering the FDA to pull Essure off the market. But, let's be realistic. Congress can barely tie its shoes, much less pass a bill to protect women. It has been referred to the Subcommittee on Health where it will almost certainly die without a vote.What Is the Settlement Value of the Essure Cases?
It is a little premature to be talking how much victims can expect to receive in any Essure lawsuit. If there are settlements, and we are likely a good ways from that even if things go well for plaintiffs. Nothing has been proven yet and it will take a lot of work in the ramp-up to these lawsuits to see just how strong these cases are. If there is a mass settlement in the Essure case , it will likely be based on the injuries suffered. So a perforated organ case is likely to be worth a great deal more than someone who has limited abdominal pain.Can I Get Compensation?
Miller & Zois is accepting Essure injury claims. If you have had a serious side effect from this medical device, you may be entitled to compensation. We can help you. Call us today at 800-553-8082 or fill out our free, no obligation claim review form.