Along with thousands of people across the country, we at Milestone have been closely following the litigation over the Essure permanent birth control. The device has been a hot button issue for several years, as the U.S. Food and Drug Administration (FDA) and trial attorneys have worked to investigate the alleged injuries and tighten the reins on its use and promotion. Last week, a major breakthrough happened in the battle against Essure: pharmaceutical company Bayer announced that the device will no longer be sold or distributed after 2018.
Although Bayer has claimed it has nothing to do with the thousands of lawsuits coordinated against the company over injury allegations, the decision comes on the heels of a patient safety action by the FDA that restricted the sale and distribution of Essure. Two years prior to that action, the FDA ordered placement of a black box warning on Essure’s packaging that warned of the risks, including device migration that could possibly require surgical removal.
An estimated 750,000 patients have used Essure worldwide since it was approved. However, women soon began reporting unexpected problems including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. Several deaths have also been associated with the device or its related complications. About 16,000 women have filed lawsuits or claims surrounding these issues. The cases were coordinated in California, after which attorney Fidelma Fitzpatrick was named Lead Counsel of the Plaintiffs’ Executive Committee.
Amid the discontinuation of Essure, FDA Commissioner Scott Gottlieb, M.D. said in a press release that women who have been using Essure successfully to prevent pregnancy can continue to do so. Patients who experience symptoms related to the device, such as persistent pain, should consult with their doctor on appropriate action to take. The commissioner noted that device removal comes with its own risks, so patients with Essure will need to weigh the benefits and risks of removing it from their bodies.
The legal battle against Essure is a great example of how trial lawyers relentlessly stand up to big corporations whose products hurt people. It is our hope that the women who were harmed by the product obtain the justice they deserve.
A West Point graduate where he served as captain and military aviator, John Bair continues his commitment to our country through his efforts within the settlement planning industry. He has represented families of victims lost in the Flight 3407 crash, offered pro bono services to the families of 9/11 victims and drafted the first consumer protection bill for plaintiffs (H.R. 3699).