Defective pharmaceutical Essure is off the market, but lawsuits are still being filed
Choosing a method of birth control is a big decision for a woman. Almost every method of contraception has side effects and risks, so most women weigh the risks and benefits with their doctors to find the solution that best meets their needs.
Essure birth control is a tubal ligation procedure (sometimes referred to as having one’s “tubes tied”). Unlike birth control pills that you take daily or an intrauterine device (IUD) that needs replacing every few years, a tubal ligation is a permanent birth control solution.
The Essure device is placed inside the uterus with its metal coils inserted into the fallopian tubes. The coils trigger scar tissue that blocks the tubes and prevents an egg from being fertilized. Essure was a popular method of permanent birth control because, unlike other methods of tubal ligation, it did not require surgery and was implanted in a doctor’s office rather than a hospital.
Problems with Essure birth control
Essure was discontinued and taken off the market on December 31, 2018. However, because it’s a permanent device, women who already have received the Essure device are still experiencing side effects.
While tubal ligation became widely available in the US in the 1960s and is considered generally safe and effective, Essure birth control is a different story.
Essure was made by Conceptus and approved by the US Food and Drug Administration (FDA) in 2002. It was acquired by Bayer, along with the IUD Mirena and other birth control options, in 2013. However, news of the dangers of Essure was spreading and members of Congress, along with consumer groups, requested a recall of the device in 2015.
In 2016, the FDA added a black box warning to the device, which provides enhanced information to users about the risks. It was mandated to be included in instructions with the device and patients would receive an information checklist. More than 750,000 women worldwide have had Essure devices placed.
When Bayer announced in July 2018 that it would discontinue selling the device at the end of that year, there were already more than 16,000 Essure lawsuits underway and more than 30,000 serious adverse event reports were filed with the FDA.
What are Essure injuries?
It’s normal to have some side-effects following a tubal ligation. Immediate and expected side-effects include:
- Abdominal pain or cramping
- Fatigue and dizziness
- Gassiness or bloating
- Shoulder pain
- Discomfort at incision site
Once you’ve healed, you shouldn’t experience further discomfort or complications.
Essure lawsuits have been filed because women experience ongoing pain and complications from that particular device. Bayer claims the device is 99% effective at preventing pregnancy, and this seems to be true. But women say they weren’t warned about the other serious risks.
Essure lawsuits are based on complications reported to the FDA, including:
- Severe abdominal and pelvic pain
- Cramping
- Miscarriages and unintended pregnancies
- Nausea and vomiting
- Abnormal bleeding
- Device migration and perforation of the fallopian tubes or uterus
- Dizziness and fatigue
- Hair loss
- Device migration and expulsion
- Internal bleeding
- Autoimmune issues
- Allergic reaction to nickel
- Death
Four women died from complications associated with Essure. In addition, there were 18 miscarriages and deaths of two infants after live births when the mother became pregnant while using Essure.
In cases with extreme complications, the Essure device could be surgically removed. Doing so wouldn’t reverse the effects of the sterilization process (a patient’s fertility wouldn’t be restored), but the complications might be treatable.
Essure lawsuit updates
There are currently more than 18,000 Essure lawsuits pending against Bayer. Each is an individual lawsuit as there are no class actions or multidistrict litigation at this time. There are reports that Essure lawsuits have cost Bayer $413 million, in addition to hundreds of millions of dollars spent on legal defense related to Xarelto, Cipro, and Avelox. These costs are related only to the costs associated with a legal defense, not settlements offered to patients.
The cause of action for the defective device is that Bayer failed to warn women of the risks. There are also allegations that Bayer knew about adverse events, and not only failed to warn about them, but actually altered medical records of patients in clinical trials to make the device appear safer.
Essure approved by the FDA for use as a contraceptive device.
Adverse Event reports are steadily being filed with the FDA.
The FDA reports that it received over 5,000 complaints about Essure.
The FDA holds a public hearing and criticized the manufacturer for how clinical trials and data were handled.
Several articles are published that highlight the negative effects of Essure.
Lawsuits are filed against Bayer regarding Essure.
Bayer is ordered by the FDA to conduct additional studies of Essure, and also requires a black box warning.
Bayer stops selling Essure everywhere in the world except the US
Bayer’s Q3 report indicates that there were 10,000 Essure lawsuits filed in the US
The FDA restricts the sale of Essure unless any woman intending to use the device is presented with adequate information about the risks. The new labeling specifies how and to what extent women must receive information before the device can be used.
As of April, 2018, there were 16,800 Essure lawsuits against Bayer and 29,000 adverse events reports filed with the FDA.
What can I recover from an Essure lawsuit?
If you’ve suffered injury from Essure, you might be able to receive a settlement based on:
- Duration and severity of Essure side-effects and complications
- Costs of follow-up treatment or surgical removal
- Ongoing care, including prescription medications for pain
- Lost income from temporary or permanent disability
- Punitive damages (costs associated with pain and suffering)
An Essure lawsuit would be under the defective product liability category of personal injury litigation. Defective product lawsuits are filed when a person is injured because of a manufacturing defect, design defect, or (as in the apparent case of Essure) the manufacturer’s failure to warn of a product’s dangers.
Defective drugs and medical devices are even more specialized within the law. It hinges on the same elements, but sometimes there is more than one defendant. For instance, if the doctor who placed your Essure, or the hospital or clinic where the procedure was performed, didn’t adequately warn you of its risks, they could also be within the “chain of commerce” for a pharmaceutical liability claim.
Fortunately, there are lawyers who specialize in defective pharmaceutical cases. The Enjuris Personal Injury Law Firm Directory is a guide for you to find the right attorney based on where you live and what you need. In fact, there’s also a downloadable checklist to prepare you for the first meeting with a personal injury lawyer.
Your First Meeting with an Attorney
A worksheet to prepare for your first meeting with a personal injury attorney – what to bring, what they'll ask
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If you’re experiencing Essure side-effects, you shouldn’t have to suffer alone. An experienced, compassionate defective pharmaceutical lawyer will help you receive what you need for treatment and ongoing care.
See our guide Choosing a personal injury attorney.