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 tubes. 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:
Additional surgeries, including hysterectomy to remove the device and repair internal organs
Autoimmune response to the device, including fatigue, rashes, hair loss and weight gain
Chronic pelvic pain
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)
Expulsion of the device
Perforation or tear of pelvic organs, including uterus or colon
Severe migraines and allergic reactions to the device or device components
Fidelma and Carmen have experience representing women alleging harm by defective medical devices, including transvaginal mesh and Mirena®, as well as potentially harmful medical drugs, including various types of birth control such as Yaz®.
Complaints about Essure
From the time Essure was approved by the FDA in 2002 to December 31, 2015, the FDA has received 9,900 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 available 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 complications and removal, including such issues as when physicians 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