Here you will find all the frequently asked questions about Essure, Conceptus Inc’s controversial birth control device, its danger, risks and much more (FAQs).
GENERAL AND SAFETY QUESTIONS
Q: What is Essure?
A: Essure is a permanent contraceptive method that does not require laparoscopic tubal ligation surgery. It consists of two metal coils implanted inside a woman’s fallopian tubes without any need for anesthesia or invasive surgical procedures. Within three months, scar tissue will form around the two coils effectively blocking sperm cells from reaching the eggs. This device is manufactured by Conceptus Inc. and Bayer AG and was approved by the US Food and Drugs Administration (FDA) at the end of 2002.
Q: Do I still risk becoming pregnant after being implanted with Essure?
A: The manufacturer granted that this device can prevent pregnancy in up to 99.83 percent of subjects tested. However, a very recent study published in the medical journal Contraception showed that about 10% of women who were implanted with Essure were still able to conceive children. Also, the original research that proved this device’s alleged effectiveness did take into account only women from 21 to 45 years old.
Q: Can I remove Essure after I have been implanted with it?
A: Technically it’s possible to remove this device whenever its side effects become unbearable, but it’s not a simple procedure. Hysterectomy will entirely remove a woman’s reproductive apparatus, with long-term consequences such as incontinence and organ prolapse. Alternatively, salpingotomy is less invasive, but it is a very delicate and uncommon procedure that will require a specialized surgeon.
Q: What are the Essure side effects and symptoms I should be worried about?
A: The symptoms that should alarm you are those which may indicate an internal hemorrhage or organ perforation. These include heavy bleeding, chronic fatigue, excruciating pain, constant headaches and muscle pain. Also, symptoms which may point to a nickel allergy such as skin rashes, blisters, itching or redness should not be underestimated as they may lead to anaphylactic shock. Seek immediate medical advice in case you suffer from one or more of these symptoms while under treatment with this drug.
ESSURE SIDE EFFECTS AND DANGERS
Q: Why is Essure dangerous?
A: Many women complained several types of side effects after being implanted with this device. According to their stories, some of them suffered permanent damage after the device broke or migrated to other organs, perforating them and causing tremendous injuries. Other well-known Essure side effects may be less severe, but they can still significantly affect a woman’s quality of life such as weight gain, headaches, constant pain, heavy menstruations, depression and mood swings.
Q: Can I die after being implanted with Essure?
A: Although very few death cases have been registered by the FDA Adverse Event Reporting System (FAERS), the risk still exists. Essure can kill you as a consequence of organ perforation, or a severe reaction to nickel in allergic subjects.
Q: Is Essure going to be recalled since it is so dangerous?
A: After the FDA had issued a recent panel to reassess this device’s safety, the regulator determined that real-life data provided additional evidence about its other risks. Although the FDA did not issue a product recall, a “Black Box” warning was added to the device’s label to inform the public about its dangers. Now both patients and physicians as well need to sign an informed consent before Essure can be implanted.
Q: Is there anyone who I can talk to if I want to share the problems I had with Essure?
A: In the last few years thousands of women complained about all kind of Essure problems, many of which so serious their lives were permanently affected. You can find a lot of similar stories on the web by seeking the famous E-sisters who are taking their fight against Bayer and Conceptus Inc. The famous consumer advocate Erin Brockovich also began campaigning against the Big Pharma to defend women’s rights and protect them from discrimination.
Content written by: Dr. Claudio Butticè, Pharm.D.