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Implanon Lawsuits Allege Women At Risk of Side Effects

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Columbus, OHWomen have filed Implanon lawsuits alleging problems with the birth control—including migration from implantation site—put them at risk of ongoing Implanon side effects and possible infertility. The US Food and Drug Administration (FDA) has issued an update to the Warnings and Precautions section of the birth control's label, alerting users to the risk of device migration.

According to documents filed in relation to one lawsuit, women who had the device implanted and experienced spontaneous migration of the implant are at risk of infertility, ectopic pregnancy, drug-related adverse events, and neural and vascular damage. The problem, they allege, is that in some women who experience device migration the device becomes irretrievable and therefore stays in the body.

Implanon is a matchstick-sized implant used to release a synthetic progestin that prevents pregnancy. It was approved by the FDA for use in July 2006. A doctor injects the implant into the patient's arm and then confirms placement after the injection. Implanon is only meant to be implanted for approximately three years and was, according to the lawsuit, marketed as reversible whenever the patient wanted it removed before then.

The plaintiffs allege Implanon's makers and marketers knew or should have known about both the risk of the implant migrating and the possibility that there would be no way to find the implant once it had migrated. That's because Implanon is not radiopaque, so imaging technologies could not find it if it moved too far out of place.

On May 14, 2012, Brook Reynolds had Implanon inserted in her left arm, with no complication. In 2014, Reynolds reportedly decided to have the implant removed but her doctor was not able to locate the implant to take it out. As of the filing of the lawsuit, Reynolds still has the Implanon somewhere in her body.

"As a result of her lost, irretrievable and irreversible implant, Plaintiff is at risk for serious and even potentially deadly adverse events, including but not limited to, ectopic pregnancy, the inability to stop drug-related reactions, additional unwanted side-effects of the medication and neural or vascular damage," the lawsuit states.

Reynolds further alleges that she is at risk of future infertility.

Similar to Reynolds, plaintiff Ruby Ginns was also reportedly a recipient of the Implanon birth control implant but around six months later decided to have it removed. When her doctor attempted to remove the device—including through surgery—the implant could not be found.

In March 2016 the FDA approved an update to Implanon's label. The update warned that there was a risk associated with implant migration and that surgery may be required to remove the implant.

The lawsuit is Reynolds et al v. Merck Sharp & Dohme Corp., case number 3:15-cv-397, in the US District Court, Northern District of Ohio Western Division.



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