Essure is a dangerous contraceptive device that marked thousands of women’s lives with its side effects that often caused gruesome long-term injuries. Originally advertised as a safe, permanent birth control method, Conceptus’ device eventually proved to be extremely hazardous to patients who were implanted with it. Punctured fallopian tubes, internal hemorrhages, chronic, unrelenting pain and organ perforation are just some of its most common, and most threatening, side effects.
What is Essure?
Essure is a permanent birth control device developed by Conceptus Inc. and Bayer AG that received clearance for marketing by the U.S. Food and Drug Administration (FDA) in 2002. It grants female sterilization without requiring a surgical incision, and it’s used as an alternative to laparoscopic tubal ligation. During the procedure, a surgeon inserts two small, flexible coils called “micro-inserts” inside the fallopian tubes. After a few months, scar tissue forms over the inserts, effectively blocking sperm cells from reaching the tubes, providing irreversible contraception.
Although Essure was advertised as a simple, convenient solution that let many women obtain reliable birth control without the need of a scary surgical intervention, the grim truth about its dangerousness rapidly surfaced in just a few years. At least 5,000 adverse reaction reports have been filed jus between 2013 and 2015, and the scenario depicted by most of them was as grisly as it could be. Some victims reported the coils broke and their fragments migrated to other organs, causing perforations, internal bleeding and permanent injuries. Others ended up in the operating room requiring emergency reoperation, and, in some instances, only a full hysterectomy could save them. The luckiest patients reported less threatening side effects such as recurring migraines, depression, cramps, bloating and chronic discomfort that still negatively affected their long-term quality of life.
Why is Essure a dangerous device?
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.
The number of complaints was so high that recently the FDA was forced to add a black box to warn doctors and patients about this device’s dangerous adverse reactions.
- 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
Essure complications found during clinical 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.
A prestigious study recently 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 also found convincing evidence that at least 30% of the data used by the manufacturer to prove Essure’s reliability was, indeed, faulty.
On top of all the injuries inflicted by it, the device is not even as effective as originally thought to be. In 2015, the FDA reported at least 600 unexpected pregnancies, of which almost 100 were ectopic ones.
Article by Dr. Claudio Butticè, Pharm.D.
