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Do You Have An Essure Sterilization Device Claim?

Ennis & Ennis, P.A. Jan. 21, 2016

01/21/2016 - Over the past few weeks, many women may have seen television and Internet advertising regarding the Essure Sterilization device and its complications. This article is to provide users of the Essure device with information regarding why you may be entitled to compensation for injuries caused by this dangerous device. The Essure device was approved for use in the U.S. on November 4, 2002. Essure is a permanent birth control device consisting of a four-centimeter coil placed into each fallopian tube to prevent pregnancy by causing severe inflammation creating a total blockage of the fallopian tubes. The coil contains nickel, which some women are unknowingly highly allergic. 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.

Currently, the Essure device enjoys protection from civil liability pursuant to a legal vehicle called preemption. Significant efforts are being made on different fronts to circumvent preemption, have the Essure device removed from the market and to restore victims’ rights to sue. Petitions have been filed with the FDA to have the PMA for the product revoked. Efforts are being made to lobby Congress to enact the E-Free Act to require the FDA to revoke the PMA for Essure. In terms of litigation, lawsuits are currently being prepared and filed in jurisdictions around the country. In order to circumvent preemption, a claimant must allege parallel state law claims, which are not covered by preemption. The strongest claim is the Essure device was defectively manufactured. This would encompass allegations the product was manufactured in a way that was not approved by the FDA and could include such allegations as the devices were improperly welded or soldered together for example. Other possible claims include false marketing/fraud, breach of express warranties and improper training of the implanting physicians.

Many women are concerned when their statute of limitations or time frame in which to bring a claim will run. Each state has a different statute of limitations period, typically between 1-5 years. Many states have either one or two-year statute of limitations periods, so time may be of the essence. Some states also have a discovery statute that typically provides that the time period does not begin to run until the plaintiff knew or reasonably should have known of the injury and that it was wrongfully caused. Many women did not immediately correlate their symptoms to Essure and most were vigorously advised by their physicians that their symptoms were in no way connected to the device. In many cases, it will be a fact question to be determined by a jury whether a claimant’s statute of limitations period expired prior to bringing a claim.

Many women have questioned whether their Essure device has to be removed in order to file a claim. Any women who has the device and has suffered an injury may file a claim, regardless of whether she has had the device removed. Different factors will go into the determination of the amount of compensation a women may be entitled to, however, removal is not a prerequisite to filing a claim. There are many types of injuries related to the Essure device and they may compensated accordingly. The Essure lawsuits will not be a class action suit, but each woman will have her own individual claim. 

Hiring an attorney is not difficult or expensive. Attorneys handling personal injury litigation work on a contingency fee agreement. This means the attorney receives a percentage of the recovery received in the litigation. If there is no recovery by the client, then there are no fees or costs charged to the client. Consultations to determine whether a client has a case are also free. Women who have been implanted with the Essure device may be entitled to pursue their claim against Bayer/Conceptus by contacting Holly Ennis at Ennis & Ennis, P.A. by going to