What is Essure?
Essure is an implantable birth control device for women. It was developed by Conceptus Inc., a subsidiary of Bayer AG, and was approved by the Food and Drug Administration for use in November of 2002.
The Essure procedure was touted as “less invasive” and “cheaper” than laparoscopic bilateral tubal ligation, the standard surgical method for sterilization.
More than a decade after its initial approval, the FDA issued warnings about the device’s long term safety. These warnings included possible complications such as (but not limited to), intractable pain and bleeding leading to hysterectomies, tubal perforations, possible device-related deaths and hundreds of unintended pregnancies.
Essure was designed to be a permanent method of sterilization. However, the drug was only studied clinically in a short-term premarket study. Only 92% of women followed up at the one year mark and only 25% followed up at the two year mark. Essure is still being marketed to women today.
What complications are associated with Essure?
Essure has been linked to a wide range of extremely painful and potentially life-threatening conditions. If you have an Essure implant and have experienced any of the following conditions or symptoms, contact your healthcare professional immediately.
- Perforation, expulsion, or other unsatisfactory location of the insert
- Complications resulting in hysterectomy
- Punctured uterine walls
- Pregnancy and increased risk of ectopic pregnancy
- Pain, cramping or vaginal bleeding
- Menstrual pattern changes; such as light periods at first, then longer and heavier periods lasting 6-8 weeks due to changing birth control methods to a non-hormonal solution
- Nausea and vomiting
- Vasovagal response (fainting)
- Allergic reaction to the materials
- Heightened allergic response to other allergens
- Heavy metal toxicity
- Itchy, raised rash
- Brain fog
- Autoimmune disease symptoms
- Weight gain
- Anxiety and depression
- Hair loss
- Severe anxiety
- Numbness of extremities
- Joint pain
- Back pain
- Suicidal thoughts
The FDA has received over 5,000 complaints about Essure. The device has been linked to seven deaths. Essure is still being implanted in women today.
Essure and unintended pregnancy
Essure has been linked to numerous cases of unintended pregnancy around the world. In a study published by Science Direct, results showed 10 unwanted pregnancies in the Netherlands alone. The study results showed that, “Most pregnancies occurred in patients with only one device placement and bilateral occlusion on hysterosalpingography (HSG). Other cases included misinterpretation of HSG, undetected abnormal device position by ultrasound, one undetected pre-procedure pregnancy, and two patient failures to follow up with the physician advice.” It went on to state, “A procedure with only a single device placement in a patient without a history of tubectomy of the heterolateral tube should be considered unsuccessful.” Many of these devices were implanted improperly by physicians, leaving women open to pregnancies they were attempting to avoid.
Essure and hysterectomy
A large portion of women who chose to have their Essure implant removed ended up having to undergo a hysterectomy; a surgical operation to remove all or part of the uterus. This procedure creates a complete change in a woman’s hormonal system, resulting in immediate or early onset menopause. Most of these cases were caused by device migration or perforation, which are outlined below.
Essure device migration
Device migration is when the Essure implant moves from its original position, causing pain and further complications. There have been numerous reports of Essure device migration. This condition is so prevalent that some doctors are choosing to specialize in the removal of the Essure device. One specialist’s website claims they have performed over 150 Essure removal surgeries in North Carolina alone. Symptoms of device migration include:
- Abnormal bleeding
- Abdominal pain
- Lower back pain
- General feeling of discomfort and illness
- Nausea or vomiting
Perforation of Essure is the most common adverse complication. It can cause extreme pain and uncontrollable internal bleeding. Perforations occur when the implant is inserted too far (or not far enough) into the fallopian tube. Even if Essure is implanted correctly, muscle spasms and normal athletic movement can cause perforations months or years later. Women suffering from a perforation often have to have emergency surgery. The device may perforate the fallopian tubes, uterus, cervix, fetal membrane, bowel or abdominal organs.
Has action been taken against Essure and Conceptus Inc.?
King 5 Washington reports,“A lawsuit filed in Nov. 2016 in the Alameda County Superior Court on behalf of dozens of women all over the country claims the company that created the sterilization device Essure didn’t warn women of serious and life-altering complications.” The story goes on to state major health complications women have experienced such as autoimmune disease, irregular bleeding, unintended pregnancies and abscesses. It was stated, “The doctors don’t believe them. The insurance companies won’t pay for removal. They get shuffled around to all these different specialists and they are desperate to have the surgery and have these devices removed.” This is just one of dozens of personal suits filed by women across the country, claiming the drug giant Bayer AG knew of the potential harm Essure could cause. Bayer AG posted profits of $4.83 billion in 2016.
Essure in their own hands
Recently those injured by Essure have rallied together on the popular petition website, change.org. With over 1,400 signatures, this petition aims to ask government agencies to force Conceptus Inc. to remove the device from the market. The woman who started the petition wishes to remain anonymous, but she was quoted as saying that they were simply attempting to “fight to get our lives back”. Essure is still on the market.
Essure and Conceptus Inc. in summary:
Essure is an implantable birth control device for women. It was developed by Conceptus Inc., a subsidiary of Bayer AG, and was approved by the Food and Drug Administration for use in November of 2002. Essure was touted as “less invasive” and “cheaper” than the alternative surgery for sterilization. Essure has been linked to a wide range of painful and potentially life threatening conditions including, but not limited to, perforation, unintended pregnancy, punctured uterine walls, pain, cramping, vaginal bleeding, menstrual pattern changes, and many more. The drug was only clinically studied in a short-term premarket study. Roughly 92% of women followed up at one year but and only 25% followed up at two years. The reasons for injury from Essure range from improper insertion of the device to allergic reactions to the metal. Dozens of personal lawsuits have been filed by women across the country, claiming the drug giant Bayer AG knew of the potential harm Essure could cause. Bayer AG posted profits of $4.83 billion in 2016. At the time this article was published, Essure was still being implanted in women all over the USA.