The Essure permanent birth control has been on the market since 2002, when the FDA approved the product as the only non-surgical female sterilization method. The Essure permanent birth control offers women who no longer want to have children an alternative to invasive hysterectomy surgery.

In contrast to traditional tubal ligation, the Essure permanent birth control is minimally invasive and does not require a long recovery period. The Essure permanent birth control product consists of two metal coils that are inserted into each of the fallopian tubes, which is supposed to spur growth in the surrounding tissue.

Once the tissue grows around the coils, it will prevent sperm to egg fertilization. With how convenient the permanent birth control method it is, it is not surprising that hundreds of thousands of women have opted for Essure.

Approximately 750,000 women have opted for the Essure contraceptive since its release. It has been a major success for Bayer HealthCare. While the permanent birth control device was originally developed by Conceptus Inc., Bayer had acquired the rights for the Essure shortly before its release.

Even though the Essure device is considered a breakthrough for the contraceptive market, a number of women have reportedly suffered serious device complications soon after implantation.

Overview of Essure Complications

The Essure permanent birth control coils are made of certain metals including nickel, which has reportedly been the cause of many allergic reactions in patients.

While Bayer HealthCare had allegedly reported that the permanent birth control device caused only mild side effects, the FDA had conducted its own investigation of the Manufacturer and User Facility Device Experience (MAUDE) database.

According to the FDA, the agency had received approximately 5,093 injury reports between November 2002 to May 2015, with most of the reports being voluntary submissions from women who experienced serious device complications including:

• 3,353 injury reports of Abdominal Pain
• 1,408 injury reports of Heavy Periods
• 1,383 injury reports of Headache
• 966 injury reports of Fatigue
• 936 injury reports of Weight Fluctuations
• 941 injury reports of Device Incompatibility
• 482 injury reports of Device Migration
• 301 injury reports of the device working in an unexpected way
• 259 injury reports of Device Breaking
• 133 injury reports of Change in Device Position

Other serious device complications associated with the Essure permanent birth control device also include organ perforation, miscarriage, and ectopic pregnancy. Women have alleged their unexpected pregnancies were results of device failure, which had also caused major pregnancy complications like miscarriage or an embryo forming outside of the uterus.

Even with these injury reports, the FDA has opted not to recall the Essure permanent birth control device from the market. The agency has noted that it considers the device to be an important option for women’s healthcare. Consumer advocates are currently trying to have the Essure recalled from the market, with many of them stating the device should not have received FDA approval in the first place.

Women who suffered serious Essure complications may be eligible to file legal action against Bayer HealthCare, for allegedly failing to warn the general public. Potential claimants can seek possible compensation for their injuries, which may have been caused by the Essure permanent birth control device.