In a previous blog post, we mentioned an episode of Last Week Tonight that focused on dangerous medical devices. In that post, our primary focus was the dangers of pelvic mesh, which was one of the devices that host John Oliver discussed during the segment. Another medical implant on show was the Essure device for permanent birth control.
The Brooklyn, NY attorneys of Zucker & Regev, P.C. would like to focus now on the dangers of Essure. We’ll cover what it claimed to do, the issues with its testing and clinical trial ratings, and what options you may have to seek damages against Bayer, who acquired the design for Essure from Conceptus.
About the Essure Device
Essure was an FDA approved birth control device for permanent sterilization. Essure consisted of two 4 cm coils that were placed into a woman’s fallopian tubes. The presence of these small coils triggered an inflammatory response, creating scar tissue that sealed the fallopian tubes shut and made pregnancy through natural conception virtually impossible.
Serious Side Effects from the Essure Device
While patients who received Essure were guaranteed that the procedure would be painless, many women experienced cramping and various degrees of discomfort soon after having their Essure device placed.
For some women, the presence of the Essure coils resulted in systemic inflammation similar to an autoimmune disorder. Other women developed connective tissue problems, and still other women experienced inflammatory arthritis. All of this was linked to the presence of the Essure coils in their system.
Medical Procedures to Address Essure Problems
Surgeons felt that removing the Essure should help reverse these medical issues, and yet this proved difficult. During removal procedures, the Essure coils would break up into tiny fibers that were difficult to entirely remove. In some cases, the Essure devices dislodged and wound up in the uterus without surgical intervention. Yet even with the Essure device removed, side effects could persist.
A number of women who had Essure eventually had to undergo hysterectomies due to their serious side effects they experienced. And yet even then, these women might experience subsequent issues with incontinence or sexual dysfunction for years to come.
Issues with the Clinical Trials and Surveys
As Last Week Tonight revealed, initial high clinical trial ratings for Essure were not an accurate reflection of what patients experienced.
In a clip from the documentary The Bleeding Edge, two clinical trial patients revealed that nurses coerced them into picking misleading survey responses. One participant was told by a nurse to rate her comfort with Essure as excellent even though she experienced abdominal pain. Another clinical trial participant was told by a nurse to rate her patient satisfaction as high because she was not pregnant despite her numerous medical side effects from the device.
Holding Bayer Accountable
Our Brooklyn attorneys do not believe that Bayer should get away with harming the lives of so many women. That is why we urge you to speak with us if you have had an Essure device placed and have experienced medical problems as a result. We can seek damages from Bayer that address your medical expenses and related needs.
Learn More About Essure Legal Settlements
You have an Essure device and would like more information about your legal options against the makes of this device, contact a skilled medical product liability attorney. You can reach Zucker & Regev in Brooklyn by calling (718) 624-1211.