The Problem: Essure a permanent birth control device is alleged to have serious complications ranging from mild to fatal.
The Response: The FDA continues to issue label updates regarding reports of serious complications.
What Can We Do to Help: Our experienced attorneys can review your medical records and advise you if filing a case is in your best interest.
The attorneys at Gallon, Takacs & Boissoneault are investigating allegations that women have developed serious complications from the implantation of the Essure Permanent Birth Control Device. If you or someone you know developed serious complications from the Essure Permanent Birth Control Device, contact us today. Find out if you can seek compensation for your injuries by completing our free case evaluation.
In hundreds of cases, the device has “operated differently than expected,” broken, or been difficult to remove. In some instances, the device has damaged the soft tissues and organs of patients.
Essure, a permanent birth control implant manufactured by Bayer, hit the market with FDA approval in 2002. Since that time however, many women have come forward complaining of various complications, including continual pain and device migration. Essure lawsuits against the manufacturer and physicians who improperly implant the devices are on the rise.
The FDA has recently stepped in, ordered Bayer to conduct more studies on the device’s safety, and mandated changes in the product’s labeling to reflect the dangerous potential side effects.
What kinds of problems are patients experiencing with Essure?
Essure, a device comprised of flexible coils, is a nonsurgical means to permanently prevent pregnancy. Doctors insert the flexible device through the vagina and cervix, and into the fallopian tubes.
After implantation, the body begins to manufacturer scar tissue around the device, which creates a barrier that ultimately is supposed to prevent sperm from reaching the eggs. It takes about three months after implantation for the scar tissue barrier to develop.
However, thousands of women have suffered complications, ranging from mild to fatal. Some of the problems women are having include the following:
- Menstruation issues, including heavy bleeding and multiple periods in a single cycle
- Headaches, dizziness, nausea
- Weight fluctuations
- Chronic, debilitating pain (in the back, abdominal, and pelvic region)
- Allergic and hypersensitive responses
- Unwanted pregnancy (the FDA has received reports of well over 600 women with Essure devices who conceived.)
There are far worse complications than those above, too.
There is a risk that Essure can perforate or puncture women’s uteruses or fallopian tubes. In other cases, the device has dislodged and migrated to the pelvis or abdomen, causing severe damage along the way. Additionally, there have been over two dozen fatalities associated with Essure, including deaths of patients, fetuses, and infants.
What is the FDA doing about Essure complaints?
Since Essure’s release, the FDA has issued several changes to the product’s label. For instance, in 2011, the FDA mandated that Bayer update the physician labeling to include a nickel sensitivity warning. Then in 2013, Bayer once again had to update the Essure label, this time to warn patients about the risks of chronic pain and device migration.
In the FDA’s most recent press release concerning Essure, the agency alerted consumers about some of the risks of the device and ordered a new, mandatory clinical study of its potential dangers.
This new post-market surveillance study will “provide important information about the risks of the device in a real-world environment…and help the agency to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation. The study will also evaluate how much these complications affect a patient’s quality of life,” the FDA explains.
The agency also announced in this February 2016 press release that it was mandating that Bayer put a “boxed” or “black box” warning label on Essure, the most serious type of warning label that denotes “serious or life-threatening risks.”
If you have experienced serious problems with the device, you can file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
What kinds of Essure lawsuits are in the works?
In some instances, patients (plaintiffs) have filed medical malpractice suits against their doctors for making unreasonable mistakes with the implantation, such as incorrect positioning. When doctors use improper procedures, do not explain risk factors, or fail to check for fertility after implantation, patients can suffer serious harm, giving them just cause to sue for damages.
Given the serious complications associated with Essure, many patients (or their loved ones in fatal cases) are also filing suit against the manufacturer. Most of the lawsuits allege that Bayer failed to sufficiently inform consumers about the risks of serious side effects.
Some women have had to undergo hysterectomies (the only way to completely remove Essure), some have gotten pregnant and given birth to infants with birth defects, and some have died. Plaintiffs are suing on the grounds that Bayer downplayed the hazards, even touting on its Essure site: “Worry free: once your doctor confirms that your tubes are blocked, you never have to worry about unplanned pregnancy.”
One complaint in which 32 women were suing Bayer for serious and permanent injuries, notes, “Bayer purposefully deceived not only the FDA, but our nation’s physicians and ultimately their patients who entrusted their lives, health and well-being on the promise of a safe, effective product.”
What do I do if I sustained injuries from an Essure implant?
If you have suffered serious complications as a result of Essure, we encourage you to seek legal counsel. You may be entitled to damages including for your medical bills, rehabilitation, lost wages, disability, emotional injuries, the cost of caring for a child with birth defects, pain and suffering, and other losses associated with your injuries.
Gallon, Takacs & Boissoneault Co., L.P.A. strongly advocates for patients’ rights, and we are spearheading claims and litigation against Bayer for the harm they have caused.
We facilitate both product liability and medical malpractice cases for patients and their loved ones, and in each case, we make valiant efforts to maximize our clients’ settlements and help them fully recover financially. They deserve it. Winning a suit cannot undo the pain and harm that our clients and their families suffered, but it gives patients funds to take care of their needs and peace of mind to move on with their lives.
If you or anyone you know has serious complications from using the Essure Permanent Birth Control Device, you may be entitled to compensation. The Essure Permanent Birth Control Device Attorneys at Gallon, Takacs & Boissoneault are dedicated to ensuring manufacturers are held responsible for the dangerous side effects of their products. Call our Essure Permanent Birth Control Device Attorneys at Gallon, Takacs & Boissoneault or fill out the free case evaluation. We want to help you.