Tens of thousands of women are complaining about painful and serious side effects after using Essure, a medical device that promises to be a form of permanent birth control. According to a CBS news report, the device has generated nearly 27,000 complaints to the Food and Drug Administration (FDA) since it was approved in 2002. Women who have gotten this device have complained of excessive pain, severe allergic reactions and in some cases, even perforated organs.
Even though Essure is FDA-approved, the regulatory agency recently restricted the device’s sales to physicians who provide patients with information about the risks. The FDA also issued a black box warning in 2016. Bayer, which manufactures the device, has acknowledged there is no way to know who might develop complications. Essure consists of two small flexible coils that are inserted into the fallopian tubes where they are supposed to form scar tissue blocking the tubes and preventing pregnancies.
Serious and Painful Complications
Several women who spoke to CBS say the device changed every aspect of their lives. One woman, Amanda Rusmisell, said she got Essure after her doctor recommended it as a newer method of permanent birth control that doesn’t require invasive surgery. Rusmisell was told she could go back to work and would have “no problem at all.” But Rusmisell said she experienced the worst pain she had ever experienced. She had heavy, painful periods, which prevented her from going to work.
Rusmisell had to eventually get a hysterectomy at age 38 because of the pain and horrific symptoms. She then found the Essure Facebook page and realized she was not alone and tens of thousands of women who got the device were suffering from serious side effects including excruciating pain, severe bloating, organ damage and metal allergies.
Many women, in their 30s, like Rusmisell, have had to get their uterus removed because the pain and complications became unbearable. The victims of this defective product have been lobbying to get this product off the market, and they’ve received support from the likes of consumer advocate Erin Brockovich.
Product Liability Issues
As product defect attorneys who have represented clients who have been harmed by substandard medical devices, we hope Essure in taken off the market. It is unacceptable that tens of thousands of women were misled into believing that these products were harmless and perfectly safe, when they were not. Victims absolutely have the right to seek justice and fair compensation for their tremendous losses and we hope they get their day in court.