Essure Lawsuits and the Black Box Warning

Women implanted with the contraceptive device Essure are filing lawsuits after suffering horrific injuries such as a punctured uterus and fallopian tubes caused by its coils. Even if the company that manufactures this birth control method keeps saying it’s safe, at least 5,000 victims reported suffering from serious side effects after receiving an implant.

If you or a loved one suffered any long-term damage, including chronic pain or organ perforation after this medical device was inserted, you may qualify for a large cash settlement.

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What is Essure and how it works?

Originally conceived by Conceptus Inc., a subsidiary of Bayer AG, this device is as an alternative permanent birth control method for women that did not want to undergo surgical laparoscopic tubal ligation. The US Food and Drugs Administration (FDA) granted Essure approval on November 4, 2002 (1). The company should be held responsible for all the suffering and adverse reactions woman faced at the hands of Bayer. Among the lawyers representing the injured, the famous consumer advocate Erin Brockovich petitioned the FDA to order a recall of this device because of its purported lack of safety and advised many women to seek an attorney and file a litigation (2).
The primary benefit associated with Essure was to provide permanent birth control (female sterilization) without the need for invasive surgery or general anesthesia, thus avoiding all the risks related to these procedures. It does not require a surgical incision to be implanted. A doctor introduces the “micro-inserts” (two small metal coils) through the vagina and into the fallopian tubes. Scar tissue slowly forms around the two coils over a period of three months, blocking the tubes and preventing spermatic cells from reaching the eggs. Contraception of this kind is permanent and eliminates the need to use other forms of birth control, as well as avoiding any effect on the menstrual cycle (1).
 
However hundreds of women using this device experienced severe side effects and complications over time, including extreme pelvic and back pain or cramps that prevented them from performing daily activities, constant fatigue, heavy bleeding, headaches and weight gain. Other serious or even life-threatening complications and personal injuries included device migration and breakage that could lead to organ perforation, depression and suicidal thoughts, allergic reactions to nickel and the necessity for reoperation (3, 4).

Life Threatening Implant

If you or a family member suffered any kind of harm after being implanted with Essure, you need to file a lawsuit. Possible complications may include:

Chronic Fatigue

 

Device Allergies and Anaphylaxis

 

Organ Perforation

 

Device Breakage and Migration

 

Free Essure lawyer case review

The best way to get the compensation you deserve is to file a lawsuit against Essure

In the last few years, many victims emerged, claiming that this medical device caused them several serious injuries and health problems. Many women allegedly accuse Bayer of negligence in warning them about the potential long-term hazards since the company never mentioned there was a risk of organ perforation and extreme pelvic pain and often felt discriminated even by the FDA, who ignored their complaints.

Bayer, however, is actually shielded from all litigations filed against them as their medical product was approved via the FDA’s premarket approval process. However, some plaintiff’s attorneys sought to remove that protection, asking the U.S. District Court, Eastern District of Pennsylvania to invalidate the rules that ensured Essure’s approval. On March 2016, the court ruled that two among five of these cases can continue as they have been deemed reasonable (12). Filing a lawsuit against Bayer is not just a way to receive compensation for all the pain and damages you had to endure during these years. It is also very important to prevent other women from suffering the same fate and to make a statement against a pharmaceutical company that keeps selling its product regardless of the thousands of complaints filed by all those victims.

Call our number 1-800-553-0710 or use our form to file a claim against the company that ruined your life. We will help you evaluate your legal options for free and provide you with the highest quality legal consultation possible.

Essure Dangerous Side Effects

Essure is a contraceptive implant that represented a technology marvel when it first came on the market more than 10 years ago. This device allowed women who looked for a permanent method of birth control to undergo a sterilization procedure that did not require invasive surgical incisions. Implantation could be easily done in a day-hospital setting in just a couple of minutes. However, after more than 5,000 women filed their complaint reports claiming that the device caused them all kind of injuries and serious adverse reactions, the general opinion on this devices’s safety is a little more than just controversial. The number of complaints was so high that recently the FDA was forced to issue an investigation panel to determine if this medical device should be recalled in the near future.

  • Headaches
  • Abdominal Cramps
  • Device Breakage and Migration
  • Organ Perforation
  • Back, Neck and Legs Pain
  • Heavier menstrual bleeding
  • Unusual Bleedings and Discharges
  • Chronic Fatigue
  • Weight Gain and Bloating
  • Device Allergies and Anaphylaxis
  • Sexual Dysfunction
  • Depression and Suicidal Thoughts
  • Nausea and Vomiting
  • Mood Swings

The Unsettling results of Essure trials

Most side effects were reported by women just after being implanted with the instrument, and the over 16,000 patients who complained about these adverse reactions were never diagnosed with these issues before the operation. A study was published in 2003 in the clinical journal Human Reproduction, allegedly proving that the device was safe and sound. However, a closer look at the report’s results shows concerning data about this birth control method’s safety. Among the 200 patients who effectively received the implant, nine women suffered serious complications that required an additional surgery re-intervention. In these cases, one of the coils either perforated their fallopian tube, was expelled after a short while, or simply broke up and its fragments lodged elsewhere in their bodies.

Removing fragmented or misplaced coil

In the Essure’s pivotal clinical trial, among the 464 women who received the implant, 16 of them could not rely on it “due to expulsion, perforation, other unsatisfactory micro-insert location, or loss-to-follow-up”. At least 8 women had to undergo additional surgery to be sterilized again or to remove a fragmented or misplaced coil. In an FDA five years follow-up report, five women required had to be later hysterectomized, and that at least one patient still became pregnant.

30% of Data was skewed

Data about this birth control method’s safety was skewed and demonstrated that the device was unreliable. The FDA investigators gave approval to this device following the fast-track process, yet they raised several concerns about the lack of proper data on its long-term safety and effectiveness. All studies published only examined small numbers of women for short time spans, and up to 30% of total patients were lost during the trials. To share their negative experiences and prevent other people from being harmed by this device, many women founded a large Facebook community, calling themselves “E-sisters”. Diana Zuckerman, their president, explained that the most common reason patients are lost during trials is because they had a serious problem.

Complications and adverse reactions

To be effective, this product relies upon one of the most negatively detrimental body reactions: inflammation. After the metal coils are inserted into the fallopian tubes, they trigger an inflammatory response to which the body reacts by producing scar tissue. This tissue will eventually block the tubes, usually within 2-3 months, preventing the sperm from reaching the eggs to fecundate them. Inflammation, however, is a harmful body reaction whose consequences are usually detrimental to a person’s health. It’s no surprise then how many women complained such a large amount of Essure side effects.

Other much more dangerous and life-threatening adverse reactions, however, included the much-dreaded breaking of the device itself. Reports from clinical trials and mass tort claims filed in court included 6 patient deaths and several instances of device breaking and migration. Consequent organ perforation, infections, and injuries forced some women to undergo additional surgical intervention that required many hours in the operating room.

FDA issues the “black box” warning

Pressed by the alarming number of women reporting all kind of adverse reaction and injuries, in 2015, the FDA published a full review of all patient reports, including web-based testimonials. According to their investigation, FDA received 5093 medical device reports related to Essure since 2002, although over the 80% of them were filed after 2013. Reports also included six death cases caused by the device, and five fetal deaths occurred in women who became pregnant following placement of the device. Patients like Heather Walsh and Tanya de la Paz brought their cases to a federal court after they had to undergo additional surgeries after the coils broke and migrated, causing life-threatening organ perforations.

In June 2015, the FDA announced that on September 24, 2015, Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will reevaluate the device’s risk and safety profile by conducting an evidence-based review of the available information. Information about their decision will be communicated publically on February 2016. The risks associated with the use of this device as a birth control method are in fact so significant that a recall of this product could be issued in the near future. Even the FDA’s Summary of Safety and Effectiveness Data about Essure admits that long-term safety of this device was never properly evaluated.

At the end of February, the FDA finally classified this contraceptive device as a potentially dangerous one, and requested the pharmaceutical company to add a “black box” warning to its label. The “black box” is used to alert patients about the potentially life-threatening adverse reactions of a device or drug, and it’s designed to call attention to the most serious risks. The regulator also determined that Bayer must conduct a new three-years study on over 2,000 women to properly assess Essure’s safety and effectiveness by comparing it with other similar contraception devices. Both patients and doctors must now sign a decision checklist before the device could be implanted, and a new test must be performed after three months to ensure its proper placement and functioning.

Essure Lawsuit

Essure side effects and lawsuits

Clinical evidence confirms the dangers

In the meanwhile, a recent study published in the British Medical Journal compared the risks of laparoscopic sterilization with those associated with Essure implantation (hysteroscopic sterilization). The study is the first one that evaluates this product’s long-term safety profile, and its findings are less than comforting. Researchers found that women who were implanted with the device were at a much greater risk of ending up again in the operating room. Dr. Art Sedrakyan, the study’s lead author, explained that the surgery required during reoperation will usually be much more complicated than the laparoscopic intervention patients tried to avoid in the first place.
The study concluded that hysteroscopic sterilization showed the same risk of unintended pregnancies compared to laparoscopic sterilization, but patients have a ten-fold higher danger of ending back to the operating room.

Written by: Dr. Claudio Butticè, Pharm.D.
Visuals and Design by: Luke Kist