Our attorneys are accepting Essure lawsuit cases throughout Florida. If you or a loved one has had an Essure device implanted, you may be able to hold the manufacturer accountable for damages caused by the device. Give us a call to find out how our seasoned dangerous drugs attorneys can help. You owe us nothing unless we obtain a recovery on your behalf.
If you or someone you know has an Essure device, your time to bring a Florida Essure lawsuit and hold Bayer accountable may be limited. Every case must be brought before the expiration of the statute of limitations. So, remember, time is of the essence.
What Is Essure?
Essure is a permanent form of birth control for women. It is not a pill or hormone. Instead, it is a metal coil made from nickel titanium, stainless steel, and polyethylene fibers. It looks very similar to the spring inside some pens.
A doctor implants one coil in each of the woman’s fallopian tubes. It is an office procedure that does not require general anesthesia like other more invasive surgeries. This gives Essure a distinct advantage over other forms of surgical sterilization such as tubal ligation.
After the Essure coil is inserted, it causes scar tissue to build up in the fallopian tubes. After about three months the scar tissue causes permanent blocking of the fallopian tubes. The procedure is not reversable and the coil is intended to stay inside the woman for her entire life.
The end result is that sperm cannot get through the scar tissue and cannot fertilize the egg. Because the sperm cannot reach the egg, Essure is intended to permanently prevent pregnancy. Bayer has claimed it is nearly 100% effective in doing so.
How Is Essure Harming Women?
Although the manufacturer, Bayer HealthCare, continues to assert Essure is safe and effective, the evidence seems to indicate otherwise. It is estimated that over 750,000 women have had the device implanted. In September of 2015, the FDA reported that as many as 20,000 women have shared Essure horror stories on social media. A common pattern of injuries and damages have emerged. These women allege Essure has caused them to experience:
- Chronic abdominal pain;
- Chronic excessive bleeding;
- Unintended pregnancy including ectopic pregnancy;
- Migration of Essure into the lower abdomen and pelvis;
- Allergic reaction to the device;
- Autoimmune disease, joint pain, and fatigue;
- Unexpected surgeries including hysterectomy;
- Organ damage; and
Why Are There Lawsuits?
Essure lawsuits are being filed in Florida because Bayer is denying responsibility for these bad outcomes. The lawsuits allege:
- Bayer failed to warn of some potential side effects of Essure and that if Bayer warned of these side effects and risks, women would have chosen a different form of birth control;
- Essure was negligently designed so that it can break and or dislodge;
- Essure is a defective and unreasonably dangerous device;
- Bayer intentionally misled women about Essure;
- The manufacturer violated the conditions of its premarket approval from the FDA;
- Bayer failed to issue an Essure recall; and
- Bayer overstated the benefits and downplayed the risks of Essure.
A well-practiced lawyer in Florida can help you determine if you can hold Bayer responsible for your damages. A proactive attorney can also file a Florida Essure lawsuit on your behalf.
What Have Essure Lawsuit Lawyers Uncovered So Far?
Esure was first put on the market in 2002. Since that time more than 16,000 lawsuits have been filed. The lawsuits allege the Essure manufacturer took shortcuts in its safety testing both before bringing the device to market and after finding out about the device complications.
In 2015 The FDA created a panel to study the risks and benefits of Essure. As a result of the review, in February of 2016, the FDA ordered Bayer to conduct a study to evaluate the safety of Essure as it is being used in the real world. That study has not yet been completed. While the study is going on, the FDA is allowing Bayer to continue selling the device.
In November of 2016, the FDA to add a black box warning to include the known risk of perforation of the uterus and/ or fallopian tubes, persistent pain, and suspected allergic or hypersensitivity reactions. The FDA also required a patient decision checklist.
In April of 2018 the FDA restricted sale and distribution of Essure by requiring all health care providers to share with all patients contemplating Essure to review and sign a Bayer Patient Doctor Discussion Cheklist. The checklist advises patient of the known risks. Since the requirements were put in place there has been a 70 percent decline in Essure sales in the US.
In December of 2018 the FDA approved a revised study that extends Bayer’s mandatory follow up of women for an additional 3 to 5 years.
Essure Settlement Recall
Unfortunately, the FDA has not forced Bayer to recall Essure. However, On December 31, 2018, Bayer stopped selling the device in the United States. It is widely believed this occurred because of the restrictions placed on the device by the FDA and the rapid decline in sales since that time. Bayer continues to deny it failed to warn of product risks and the that Essure is safe and effective. Bayer claims the decline in sales was a result of “inaccurate and misleading publicity”. For example, a recent Netflix film called “The Bleeding Edge” documents the horror stories many women claim they have experienced as a result of Essure.
Given all the evidence of harm to women, it is difficult to understand Bayer’s position unless you follow the money. Bayer purchased Essure from another company for 1 billion dollars. To date Bayer has made in excess of 47 billion dollars. No one is claiming Bayer should not make a profit on selling legitimate medical devices. The real issue here is that Essure Lawyers believe Bayer should not make a profit by selling a device that harms women.
Although there is speculation that Bayer is ready to begin settling Essure cases, to date there have been no known settlements. There have also been no cases tried to a jury. On the other hand, Essure jury trials are expected in late 2019 and early 2020. As a result, it is too early to place a value on the damages Essure has caused.
Call a Florida Essure Lawsuit Lawyer Today
Distasio Law Firm is accepting Essure injury claims. Call our dedicated team of attorneys now to see if we can help you file a Florida Essure lawsuit. But do not wait too long to find out if you qualify because waiting could cause you legitimate claim to be barred by the statute of limitations.