Essure® is a device that works as a permanent contraceptive. It can be inserted into a woman as an alternative to surgical sterilization. More than 700,000 of these devices have been sold and provided to patients as a way to permanently prevent pregnancy. Unfortunately, evidence continues to mount that these devices cause serious problems, which was not revealed in the testing stage. Even now, additional testing will take more than five years to complete, leaving female patients with little warning about possible risks associated with these devices.
If you or a loved one has suffered negative conditions after having an Essure device implanted, then don't suffer in silence. Dealing with huge pharmaceutical companies can be very difficult, and this device in particular may have some protection against lawsuits at the state level. That won't stop us from fighting for your rights, and our dangerous-drug and medical-implant attorneys have experience in dealing with pharmaceutical companies and their lawyers. Call a New York dangerous medical device lawyer at Wingate, Russotti, Shapiro & Halperin, LLP, today at (212) 986-7353 to discuss your case and talk about your options.
Developed by a company named Conceptus, later purchased by Bayer, Essure is a medical device inserted into a woman's fallopian tubes, designed to act as a permanent contraceptive. As an alternative to surgical procedures such as tubal ligation, the insertion of an Essure device does not require anesthesia or a visit to a hospital. The device consists of an outer coil made from a surgical alloy called Nitinol.
Once in place, the coils expand, which causes irritation to the fallopian tubes. The irritation causes the woman's body to have a "foreign body response" to the presence of the coils. As the tissue becomes inflamed, the woman's immune system responds by surrounding the device with scar tissue, which blocks off the fallopian tubes and makes conception (more or less) impossible. The device is meant to remain in place permanently.
There have been thousands of reports of negative events associated with the placement of Essure. These include potentially serious autoimmune reactions such as loss of hair, tooth decay, weight gain, fatigue, and pain or joint stiffness. Some women have experienced potentially serious bleeding, and intense pain at the site of device placement. In extreme situations, the device has broken apart or migrated within the patient, resulting in internal injury and even puncturing the organs.
The Nitinol used to make the device is a metal alloy mostly consisting of nickel. It is estimated that about 20% of women are allergic to nickel, yet there is no requirement for an allergy screening before implanting the device.
There is also a low failure rate for women using the device, which means that some women have still gotten pregnant even with the use of Essure. This can result in additional complications during pregnancy, including miscarriage. Removal of the device is extremely difficult, often requiring a hysterectomy, because it is designed to be permanent.
Before implanting an Essure device, you are supposed to have the known risks presented to you by your doctor. This includes a pamphlet with information about implanting the device and the risks of allergic reactions and other complications. You and your doctor are supposed to each sign a checklist showing that you both know the risks involved, but if your doctor failed to warn you about these dangers, then you may have put yourself at risk without even realizing it.
Although Essure was classified as a Class III medical device, which gives it protection from state-court lawsuits, some states have allowed suits against Bayer to go forward. You can take action against companies that produce devices that put your health at risk. Call us at Wingate, Russotti, Shapiro & Halperin, LLP, today at (212) 986-7353 to tell us about your product liability case and let us fight for you.