Unfortunately, many Essure patients are not tested for nickel allergies prior to having the coils implanted. When the device was first approved by the Food and Drug Administration in 2002, women were advised to have a skin test before the device was implanted. However, those restrictions were changed shortly after July 2011 when the manufacturer asked the FDA to remove the skin test warning. Essure’s manufacturer later advised the health care professionals of the label change and used the change to market the device to more women.
Although the current Essure label does provide a warning about nickel allergies, it is no longer required that patients are tested for the allergy. Many patients would like to know why. If the FDA thought that should be a requirement of the drug’s approval in 2002, some women wonder what caused them to make the change a few years later.
In addition to the potential reactions related to nickel allergies, Essure patients are also at risk for other serious medical concerns. In fact, Bayer recently sought FDA permission to make changes to Essure’s patient information booklet. The company will revise the booklets to include information concerning its most common side effects—chronic pelvic pain and migration of the device. In many cases, the device has led to women require additional surgeries, including hysterectomies.
The Philadelphia personal injury lawyers at Messa & Associates are experienced at handling cases involving pharmaceutical and drug product injuries. Our extremely skilled team of personal injury lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have suffered an injury as a result of an Essure procedure, a defective pharmaceutical drug product, or any other type of personal injury, contact the personal injury lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More