In a press release issued on March 15, the FDA issued a statement announcing a new investigation into adverse patient reactions to different materials used in various medical devices, including the nickel alloy nitinol in Essure birth control coil implants. As a part of this new review, the FDA announced it would be holding a public hearing on the immune and inflammatory responses that have been attributed to the nitinol used in the Essure implant.
The FDA to Investigate Essure and Other Devices
Aside from the nitinol in Essure devices, the FDA also plans to review adverse reactions to metal-on-metal hips and silicone breast implants as well.
The nitinol used in the Essure device is an alloy comprised of nickel that could potentially cause an allergic reaction in some patients. According to the Centers for Disease Control, approximately 10 to 20 percent of the U.S. population may be allergic to nickel.
In its statement, the FDA acknowledges that their current evidence suggests that a number of people may actually be predisposed to developing an inflammatory or immune reaction when exposed to certain materials.
In the past, there have been investigative reports published about practitioners being resistant to patients’ complaints about adverse reactions, as well as executives concealing unfavorable data about the Essure device.
Essure Taken Off Market in 2018
In August 2018, a class action lawsuit launched in Australia alleged that the Essure devices corroded and caused patients to develop nickel poisoning.
Essure was taken off the global market at the end of 2018, and the Australian class action lawsuit is expected to be filed in May.
The FDA also plans to review guidance for other medical devices using the same nitinol alloy used in the Essure implant.
In December 2018, the FDA announced its revised protocol for post-market surveillance in hope of better understanding how Essure affects the immune system.
The women in the study are to be followed for two additional years and more blood tests will be required to in order to better identify any potential inflammatory markers.
FDA Invests More Oversight into Essure
The agency hopes to get a better handle on some of the common symptoms associated with Essure compromising the immune system, including cognitive difficulties, fatigue, headaches and hypersensitivity reactions.
The FDA notes that many of these symptoms seem to be unique to Essure patients, and not for those with other medical devices also containing nitinol. The statement suggests that this could be due to the location of the implant.According to the FDA, the location of the specific site for the implant may affect how likely the body is to have a subsequent inflammatory or immune response.
The revised guidance set to be rolled out over the next few months will include recommendations regarding premarket submissions for nitinol devices, including testing recommendations, manufacturing information, labeling and any factors that could cause the device to breakdown inside the body.