As reports of Essure birth control injuries seem to mount, many are questioning why the coils, sold as a convenient, non-invasive method of ensuring permanent sterilization, were allowed pre-market approval by the U.S. Food and Drug Administration (FDA). Based upon confirmed medically-adverse events in the FDA databases, there have been 4,500 reports of Essure birth control injuries.

The History of Essure

Essure was approved by the FDA in November 2002 and, because of its novelty as a non-surgical way of permanently preventing pregnancy, was allegedly rushed through the review process. This hasty review process supposedly occurred because of the quicker healing time the procedure promised when compared to tubal ligation. Essure is made and promoted by the Bayer Company, which acquired rights to the device after purchasing Conceptus, the original developers of the coils.

According to a postby the Mayo Clinic, Essure coils are placed into the fallopian tubes bilaterally using a hysteroscope—a tiny camera on the end of bendable tube that allows the physician to correctly see and place each coil correctly within the tubes.

The hysteroscope must be used a second time in three months to review the progress of scar tissue development around them. It is this scar tissue which occludes and prevents the meeting of mature egg and sperm after intercourse leading to pregnancy.

The Mayo Clinic article indicates that the time it takes for this occlusion to occur can vary among women. It may take upwards of six months for some people.  In the meantime, recipients of the coils are highly advised to use back up methods of contraception such as condoms and spermicides.

The pre-market approval process for Class 3 medical devices such as Essure is very strict, but many consumers believe is not strict enough when viewed in the light of mounting Essure birth control injuries. The FDA says it required Conceptus to collect data via two post-approval studies.

These studies were to evaluate the accuracy or placement rate for doctors trained in bilateral insertion of the coils for a five-year period. In addition, the FDA wanted a five-year following of pre-market clinical trial participants for further safety evaluation.

The Benefits, Risks, and Problems Associated with Essure

While it is true that there is little scarring and none of the inconvenience associated with a surgery under general anesthesia such as tubal ligation, Essure has produced problems in a great number of women.

According to Bayer, the risk of pregnancy is very minimal once occlusion of the fallopian tubes has been confirmed. The insertion can be completed during the length of a typical doctor appointment—usually 30 minutes. This allows women to return to work and other activities a lot quicker.

Nevertheless, according to the Mayo Clinic, many recipients have reported gross allergic reactions to the nickel that makes up the coils. These allergic reactions have often been demonstrated systemically with outbreaks of hives, facial swelling, and itching.

Other Essure birth control injuries have included ectopic pregnancies where eggs become fertilized in the Fallopian tubes and cannot descend to mature. These ectopic pregnancies may result from faulty placement or migration of the coils. They usually require surgical intervention and may require partial hysterectomy. Finally, some recipients report Essure birth control injuries from migration of the coils or perforation of other organs by them. This can cause severe cases of infection.