Essure, a permanent contraceptive manufactured by Bayer, has been banned from Brazil and discontinued in 2 European countries. Over the past decade, Bayer’s Essure has faced numerous lawsuits citing ineffectiveness and dangerous reactions. Since receiving FDA approval in 2002, Essure has received more than 30,000 reports of adverse effects, leading the FDA to issue a black box warning, its strongest caution.
Developed as a permanent, non-surgical birth control device, Essure enjoyed popularity shortly after its release because of the easy insertion process without the requirement of anesthesia. The Essure device is a metal coil which, after being inserted into the fallopian tubes, will form a blockage of scar tissue to prevent pregnancy. However, not only have patients reported ineffectiveness, but the device has also lead to severe health problems.
Common adverse effects include chronic abdominal pain, intestinal tears, unintended pregnancy, hair loss, fetal death, ectopic pregnancy, abnormal bleeding, or migration of the device. A number of these side effects, especially ectopic pregnancy, can be extremely dangerous and even life-threatening to both the fetus and the mother. Some women have also suffered allergic reactions to the metal itself, causing itching, hives, and a rash.
In wake of the serious adverse reactions, Brazil’s health authority, Anvisa, decided in February of 2017 to cease all imports, distribution, and sales of Essure. Following Anvisa’s announcement, Bayer reported just this month, June 2017, they would be discontinuing Essure sales in Finland and the United Kingdom. According to Bayer, they decided to pull from 2 European countries because of a decline in sales figures, not due to any safety concerns. Bayer continues to mention the safety of their product, claiming clinical trials and scientific experience only serve to support the efficacy of Essure as a contraceptive.
While Brazil takes bold action against Bayer and Finland and the U.K. contribute to a drastic decline in sales, U.S. authorities have not taken further action against Bayer. Representative Michael Fitzpatrick introduced legislation to outlaw Essure sales in 2015, which received bipartisan support. Recently, 2 other bills were introduced to hold manufacturers responsible for harmful medical devices, but no further action has been taken.
If you or someone you love suffered a severe adverse reaction after receiving the Essure implant, our firm wants to help. At Schneider Hammers, our personal injury lawyers are dedicated to representing victims who seek justice and fair compensation for their suffering. We handle Essure lawsuits, as well as claims concerning other medical devices, such as Bair Hugger FAW, defective hip implants, INFUSE bone grafts, Talcum powder, Transvaginal mesh, and IVC filters.
Contact Schneider Hammers in Atlanta, Georgia to schedule a confidential free consultation.