Defective Medical Device Lawyers Holding Bayer Accountable
Women seeking permanent birth control generally have two options: tubal ligation (having your “tubes tied”), or a medical device called Essure. The Essure System consists of two metal coils that are placed into the fallopian tubes. Scar tissue forms around the coils, keeping sperm from traveling down the tubes and reaching eggs, thereby preventing pregnancy. Unfortunately, reports of serious injury and death from this device are growing, and thousands of Essure lawsuits have been filed throughout the country.
Oct. 31, 2016
CASE UPDATE: FDA Adds Warning and Patient Decision Checklist to Essure Labels
To help women decide whether Essure is the right choice, the FDA just updated its labels to make sure women receive and understand Essure’s risks and benefits before implantation, Essure now includes a boxed warning and a Patient Decision checklist, which should be reviewed and signed by the patient and doctor during the decision-making process.
The Patient Decision Checklist and boxed warning can be found here, on pages 9 and 10.
Please call our firm if you suffer from any of these conditions after using Essure:
- Cyst/tumor linked to device
- Device migration and organ perforation
- Allergic reactions
- Neurological damage
- Certain autoimmune disorders
- Pain, bleeding, migraines or cramping
Our firm’s intensive, thorough, detail-oriented legal approach has allowed us to secure $60+ million in verdicts and settlements for our clients. Our experience is unparalleled—both in the years we’ve spent representing medical device clients and the sheer amount of injury cases we’ve handled.
Call (800) 794-0444 for a free case consultation as soon as possible. Let us help you get the answers and justice you’re looking for.
What Is Essure?
Essure’s manufacturer, Bayer, advertises the system as a 100% effective, non-invasive, quick form of sterilization for “women on the go.” The procedure takes about 10 minutes and involves implanting the device through a small incision, without anesthesia, in your doctor’s office. The only other form of sterilization – tying tubes – requires small cuts, anesthesia, and a longer recovery time, which is why Essure is so popular.
Once inserted, Essure expands and anchors into the fallopian tubes. Over the next three months, scar tissue forms around the Essure coils, blocking the fallopian tubes so sperm is unable to reach the woman’s eggs.
What Are the Injuries?
More than half a million American women have had Essure implanted since its approval in 2002. Despite Bayer’s claims of total safety and efficacy, more than 10,000 women have filed reports of serious, debilitating, and permanent harm from Essure.
Reported injuries include:
- Chronic pain
- Device migration
- Ectopic pregnancy
- Puncture or tear of the uterus or colon
- Severe migraines
- Allergy or hypersensitivity
- Death from infection, uterine perforation, air embolism, or other Essure-related ailments
Some of these injuries, like device migration or ectopic pregnancy, are painful, life-threatening, and require surgical intervention—including full removal of the uterus. A recent study found that women using the Essure system were 10 times more likely to undergo surgery within one year than women who chose to have their tubes tied. Essure was also associated with significantly higher hospital bills.
Essure’s manufacturer, Bayer, refuses to reveal how many women use Essure, making it hard for experts to study its true risks and benefits.
Grounds for Your Lawsuit
Essure injury lawsuits claim that Bayer knowingly hid Essure’s dangers. Experts allege Bayer withheld data from the FDA during its approval process, underplaying instances of serious injury and death. Medical experts who examined the science behind Essure’s initial studies found significant flaws. These flaws include exaggerated success rates and deflated failure rates.
Consumer rights advocate, Erin Brockovich, has joined the fight against Essure, starting the website EssureProcedure.net, which tells the stories of thousands of injured women. To date, nearly 16,000 people have signed a petition to remove Essure from the market altogether. The Essure Problems group on Facebook is currently at nearly 30,000 members, demonstrating widespread opposition to this product’s use and market availability.
More than 1,000 Essure lawsuits have been filed in five different district courts and are pending consolidation in a Multidistrict Litigation (MDL) in Pennsylvania.
The FDA Hosts a Public Meeting to Examine Essure’s Risks & Benefits
In September 2015, the FDA held a daylong meeting to hear scientific, clinical, and patient opinions on the risks and benefits of Essure. During the meeting, FDA panelists harshly criticized Bayer for failing to collect data that could have predicted the actual dangers to women. The agency requested public comment before and after the meeting, which resulted in more than 2,800 submissions.
As a result of the meeting, the FDA is forcing Bayer Corporation to conduct a three-year study on 2,000 patients. This study will examine the outcomes for women with Essure versus other sterilization methods.
In addition, in February 2016 the FDA required all Essure products to have a black box warning—the most severe warning the FDA can issue. Essure must also come with a patient checklist.
Turn to Our Experienced Medical Device Attorneys in Chicago
When it comes to choosing a lawyer, you need someone who has experience handling medical lawsuits, gathering evidence, and arguing in courts across the nation. Those are our strengths, and how we stand apart from the rest; since 1985, we have handled 10,000+ injury cases—many of which involving complex medical issues and device injury.
We fly out to our clients across the United States to prepare their case and provide counsel during an extremely difficult time. We thoroughly investigate every case, creating a legal solution that effectively addresses each client’s needs and presents the facts of their injuries. Then, we partner with the top litigators in the nation to ensure the highest specialized skill and recovery.
Call (800) 794-0444 for a free case consultation. We’ll help you get the answers and help you need.