Essure

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What is Essure?

Essure is a hysteroscopic sterilization procedure, a type of tubal sterilization that does not require an incision. If a woman undergoes the Essure birth control procedure, a soft metal spring-like device wound with synthetic fibers is implanted in her fallopian tube. The metal part of the device consists of a stainless steel inner coil and an expanding nickel titanium outer coil. The fibers are used to encourage the surrounding tissue to adhere to the device, ultimately creating a barrier of scar tissue intended to block sperm from reaching the eggs.

Essure Side Effects

Reports of severe complications following the Essure procedure include:

• Chronic pelvic pain
• Death
• Improper placement leading to chronic pain, migration or expulsion
• Life-threatening ectopic pregnancy
• Migration of the device or a device component (in some cases, the device may even ‘disappear’ in the body, becoming undetectable even through standard scanning)
• Puncture or tear of the uterus or colon
• Severe migraines and allergic reactions to the device or device components

Complaints about Essure

From the time Essure was approved by the FDA in 2002 to May 31, 2015, the FDA has received 5,093 reports from doctors and women that the permanent birth control device has caused serious side effects, including 11 deaths, five of which were for fetal deaths that occurred in women who became pregnant after the Essure procedure. As a result, in June 2015, the FDA updated the number of adverse event reports involving the Essure system on its website, along with the system’s short- and long-term risks, as part of its review of potential Essure problems.

On Sept. 24, 2015, the FDA held a public meeting of the Obstetrics and Gynecology Devices Panel “to discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization.” The panel heard from medical experts as well as from women who have been implanted with the device. Along with the discussion of possible side effects and injuries from Essure such as ongoing pain, organ perforation, allergic reactions and device migration, the Panel discussed the following:

• The importance of having access to health care services that would provide access to nickel allergy tests and physicians trained in Essure system removal
• Making more training available to doctors regarding device removal that would include such issues as when they should discuss not implanting the Essure system and alternative treatments
• The importance of results from additional studies and data so that adverse events associated with the Essure system can be better understood
• Finding out more about metal reaction/sensitivity in potential Essure candidates

The panel also suggested that “patients with a known hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease and those with a history of abnormal uterine bleeding may be less suitable candidates for the Essure system.”

Click for the brief summary and the executive summary of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting.  Included is the finding that “The panel expressed a general desire to see additional post-market data on the Essure system to better
understand the adverse events that were discussed during the meeting.”

Essure’s History

The Essure permanent birth control system was developed by Conceptus, Inc. (now a subsidiary of Bayer) and underwent the FDA’s phase II and Pivotal Study patient testing between November 1998 and June 2001. The system was approved through the FDA’s Premarket Approval (PMA) process in November 2002. In 2013, Conceptus, Inc. was purchased by Bayer AG and became a fully owned subsidiary of the Germany-based chemical and pharmaceutical company.

No Recovery, No Fee For Essure Lawsuit

We take Essure litigation cases on a contingency basis. That means that there is no cost to you unless we and our co-counsel are able to recover a settlement or judgment on your behalf. So, unless your case is resolved by trial, arbitration, settlement, or other resolution, you do not have to pay any attorney fees to us, or pay any costs. Litigation costs include filing fees, court reporter fees for deposition, copying costs, experts, and travel. Litigation costs are paid by our firm so you don’t have to have cash to pursue justice against medical device corporations.

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NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming. We may work with other counsel in certain states.