Essure, a form of permanent birth control, consists of tiny coils that when inserted into the fallopian tubes via the vagina and cervix cause a type of deliberate scarring to form around them.

This scarring, if it works and maintains placement of the product, is supposed to prevent pregnancy permanently with a 99% success rate. Apart from its efficacy at preventing pregnancy, however, there have been many reports of adverse effects of Essure.

FDA Says Company Failed to Report Adverse Effects of Essure

Essure was approved for the market in 2002 after application was made by Conceptus Inc., the device’s developers. According to a ABC10news.com news story released in February 2017, the Food and Drug Administration (FDA) did two inspections of the Conceptus facilities in 2010 and 2013 respectively and found more than 15,000 reports of adverse effects of Essure that the company had not reported to them.

The FDA is supposed to kept in the loop on all reports of serious medical events (SME) or complaints on all approved medical devices and pharmaceuticals by their developers and manufacturers by law.

The FDA First Changes Essure’s Label Under Conceptus Pressure

Under pressure from Conceptus, the original label was changed in 2011 to remove a contraindication of use – nickel allergy.  The tiny coils of Essure are made from stainless steel, nickel titanium, and polyethylene terephthalate, also known as PET.

A competitor had produced a similar permanent birth control device to Essure, save the nickel components, and physicians were demonstrating a preference for its use.  This product was Adiana. Removal of nickel allergy warning from labeling of Essure would increase the product’s ability to compete in the marketplace.

The FDA Finally Changes Essure’s Warning Label for the Consumer

Over and above records found during 2010 and 2013 Conceptus inspections, reports of the adverse effects of Essure continued to mount. The Food and Drug Administration (FDA) eventually required the addition of what is known as a ‘black box’ warning to its label.  Essure’s black box label looks like this:

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or Fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.

Problems Not Listed

In addition to the risks listed in the black box warning on the new label, adverse effects of Essure may include the possibility of ectopic pregnancy leading to miscarriage or medically necessary abortion, hysterectomy, or removal of fallopian tubes and ovaries,.

If you or someone you love was implanted with the Essure device and suffered complications or injury, you may be eligible to pursue a Essure lawsuit against the manufacturer.