Essure

Essure is a non-surgical, permanent birth control device manufactured by drug giant Bayer Health Care. Considered to be a breakthrough in women's reproductive health, the device's manufacturer promised it to be completely safe. Essure quickly became a highly recommended form of contraceptive device for women who wanted permanent sterility. Because it was touted to be nearly 100 percent effective and with a very short recovery time, the device became the choice of tens of thousands of women around the country.

However, many women who have the Essure device implanted have experienced serious complications from the non-surgical birth control device. These complications include, but are not limited to: rashes, bloating, allergic reactions, device migration causing pelvic pain, excessive bleeding, organ perforation, miscarriage, and even ectopic pregnancy (also known as extra-uterine pregnancy and tubal pregnancy; a condition in which a fertilized egg implants in the fallopian tube or somewhere else, but does not implant, as it should, in the uterus). As a result of these life-changing complications, there are tens of thousands of women who report problems with the device; on social media, these women are known as "E-sisters."


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About the Essure Device

Conceptus Inc. developed the Essure device and it was first approved for use by the United States Food and Drug Administration on November 4, 2002. It is inserted rather than surgically implanted. Women receiving Essure do not need general anesthesia during the procedure. In addition, the permanent birth control device is non-hormonal. The insertion procedure only takes about ten minutes to perform and can be done in a doctor's office.

The Essure device contains flexible coils and is inserted into the patient through the vagina and cervix, and placed in the fallopian tubes. After the contraceptive is put in-place, scar tissue begins to grow around it over a three-month time period. The device and subsequent tissue growth work together to form a blockage inside the fallopian tubes, preventing sperm from reaching and fertilizing eggs, providing the patient with permanent contraception.

After the initial three-month time period in which the tissue growth occurs around the birth control device, the patient sees a radiologist for confirmation of the blockage of the patient's fallopian tubes. The test consists of a simple procedure in which a dye (known medically as a "contrast agent") is inserted through the patient's cervix and the patient is X-rayed to verify none of the contrast agent, or dye, leaks past the Essure coils, thereby confirming no sperm can reach the eggs and result in pregnancy. Since the device is intended to be permanent and not removed from the fallopian tubes, the patient will remain permanently sterile.

Because the birth control device was marketed as being almost 100 percent effective, had quick recovery time, and did not require surgery, its popularity grew rapidly. Drug giant, Bayer Health Care, made news in April 2013, when it agreed to purchase Conceptus Inc. for approximately $1.1 billion, Bloomberg Business reported; and, the Essure device continued to grow its market share.

Essure Side Effects, Problems, and Risks

Unfortunately for thousands of women who have experienced problems with the Essure device, the benefits of Essure promised by its manufacturer provide little comfort. The short-term risks identified by U.S. Food and Drug Administration about Essure include symptoms and complications ranging from mild to moderate pain, cramping, back pain, pelvic pain, and vaginal bleeding. However, the Essure device also has long-term risks, according to the FDA, which include the following:

  • pelvic pain;
  • possible nickel allergy resulting in rash and itching;
  • migration (the unintended movement of the Essure device falling out of the fallopian tubes into the patient's lower abdomen and pelvis);
  • perforation (a puncturing of the uterus or fallopian tubes);
  • unplanned pregnancy; and,
  • ectopic pregnancy (also known as tubal pregnancy and extra-uterine pregnancy).

Sadly, women who received Essure may experience any of these complications at any time after being implanted with the permanent contraceptive.


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FDA Complaints, Black Box Warning Labels, and Recall Status

Since the Essure device hit the contraceptive market on November 4, 2002, the U.S. Food and Drug Administration has received more than 5,093 reports related to problems from women who have Essure. The vast majority of the complaints have been made voluntarily. This demonstrates a strong indication the Essure device is not as safe as it was marketed to be by its manufacturer. As of May 2015, reported problems to the FDA include:

  • nearly 3,4000 complaints about heavy menses and/or menstrual irregularities;
  • more than 1,400 complaints about experiencing headaches;
  • almost 1,000 complaints about fatigue;
  • over 900 complaints about fluctuations in weight;
  • about 500 complaints about device migration or movement;
  • over 300 complaints about the Essure device performing differently than expected by patients; and,
  • approximately 250 complaints about the contraceptive breaking.

Unfortunately for women who have the contraceptive and experience device migration or device breakage, it may take several surgeries to remove Essure. What's more, device breakage or migration might require a hysterectomy. As a result of these complications, multiple lawsuits have been filed against Bayer.

The U.S. Food and Drug Administration met with Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee in September 2015 to learn about clinical and scientific opinions, along with various patients' experiences. However, the FDA has not yet issued a recall of the Essure birth control device.

In the wake of thousands of complaints and lawsuits against the drug corporation, the United States Food and Drug Administration announced in April 2016 that it's requiring Bayer to, "undertake new safety studies on its permanent birth-control device Essure, after thousands of women complained about suffering complications from the controversial implant," The Washington Post reported. In addition, the FDA requires the Bayer corporation to add a "black box" warning label to alert women about the possible serious side effects -- along with providing a checklist for doctors to help them discuss potential risks associated with Essure when consulting patients.


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About Essure Lawsuits

Though there are thousands of complaints and many lawsuits being filed against drug giant, Bayer, over issues and complications related to the Essure device, there is not at this time a "class action lawsuit." A class action is when numerous plaintiffs file civil lawsuits against a defendant. Only a small group of plaintiffs represent the many more; and if successful, all members of the group are provided with a blanket settlement. It is more likely the Essure lawsuits will combined into what's known as "multi-district litigation," or MDL. Unlike a class action, member plaintiffs' cases are resolved individually and are only joined together as a means to facilitate discovery and investigation. This means that no one plaintiff is forced to accept a settlement like in the case of a class action lawsuit.

The first lawsuit against the Bayer corporation was filed in Philadelphia in mid-2014, and since that time, many more lawsuits have been filed. Vititoe Law Group is accepting women’s cases in all 50 states who have medical complications from receiving Essure.

Because each state has different statutes of limitations, time to pursue a legal claim could be running out quickly. If you or a loved one has been implanted with the Essure contraceptive device and has experienced any issues or problems, it is imperative you speak with an experienced attorney immediately to learn about your rights and legal options.


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