Ennis & Ennis, P.A.
FDA To Investigate Possible Ban On Essure Birth Control Device
04/03/2015 - Thousands of women injured by the Essure sterilization device may be a step closer to having the device banned from the market. These women have taken the bull by the horns, refusing to accept both the continued sale of this dangerous device in the U.S. and the blocked path to the courthouse due to a legal defense called preemption. In response to a petition signed by more than 2,100 women urging the FDA to remove Essure form the U.S. market, the FDA announced it would investigate the disturbing allegations contained in the petition.
Essure consists of a pair of metal coils placed into the fallopian tubes to prevent pregnancy by causing severe inflammation creating a total blockage of the fallopian tubes. The coil also contains polyethylene (PET) fibers, which irritate and inflame the tubes, causing scar tissue to form over the coils, blocking subsequent fertilization. Unfortunately the PET fibers which create the irritation to form the scar tissue, often cause the body to fight what it deems to be an infection or foreign body, creating a host of other problems from autoimmune disorders, neurological problems, kidney, adrenal and thyroid disorders and even cancer. The coils often become dislodged, perforating the fallopian tubes, uterus, colon or other internal organs.
In 2002, the FDA granted Essure conditional pre-market approval (CPMA). Conditional Approval provides that the device could be marketed in the US as long as the manufacturer complied with a specified list of conditions. If the conditions are complied with, the manufacturer is immune from liability a practice known as preemption. According to the FDA, preemption is appropriate because new products must undergo strict scrutiny and testing to be granted premarket approval and any significant risks would be discovered before the device was marketed to the public.
However, the petition, based upon the testimony of hundreds of women, claims otherwise. The petition asserts that Essure’s PMA was not only unusually rushed, but was based on fraud, lies and cover-ups which intentionally deceived the FDA. Essure’s original manufacturer, Conceptus allegedly falsified data during clinical trials to hide or downplay adverse reactions and injuries caused by the device. Women who reported significant pain had their medical records altered to indicate satisfaction with the product or minimal discomfort. Many cases where the coils migrated out of the fallopian tubes and perforated the uterus or other organs were allegedly never reported to the FDA.
Conceptus continued to dupe the FDA by convincing it to allow the removal of a safety notice, warning women with nickel allergies not to use the device. The device is made of a nickel-titanium alloy and can cause severe allergic reaction in some women, requiring the removal of the device, often by hysterectomy. Bayer Pharmaceuticals bought out Conceptus in 2013, but has continued to deceive the FDA and the public. Bayer’s misleading advertising promotes Essure as safe and ‘worry-free’. Bayer has been issued warning letters in the past for its improper marketing of the Mirena IUD.
Bayer also promoted the Essure claiming that “no pregnancy” could occur, when in fact over 700 reported women have become pregnant with Essure, which can be quite dangerous. Essure pregnancies present both physical and emotional dangers, as women are often strongly encouraged to abort due to the dangers of carrying a child with Essure. Complications include ectopic pregnancies, miscarriage, premature birth and birth defects caused by nickel poisoning.
The FDA announced it referred the Petition to its “Office of Compliance.” It is strongly hoped that the Compliance Office will vigorously and thoroughly investigate the serious allegations raised in the Petition and undertake the necessary actions, either recalling Essure or require a black box warning notifying consumers of the dangers. If you or a loved one have been injured by Essure, contact attorney Holly Ennis at Ennis & Ennis, P.A. for a free confidential consultation.