Washington, DCMarch 2017 marked the one-year anniversary of the Food and Drug Administration (FDA) update of the warning label of the popular implantable birth control device Implanon to include risks of device migration.
Implanon is a matchstick-sized rod containing a birth control drug that is inserted by a medical professional into the patient's arm. The device is supposed to be effective for three years.
However, in March 2016, the FDA updated Implanon's label to include a safety warning that there have been reports of the medical device migrating from the arm to other parts of the body.
According to the 2016 FDA safety label update:
"There have been reports of migration of the implant within the arm from the insertion site, which may be related to deep insertion. There also have been post-marketing reports of implants located within the vessels of the arm and the pulmonary artery, which may be related to deep insertions or intravascular insertion.
"In cases where the implant has migrated to the pulmonary artery, endovascular or surgical procedures may be needed for removal."
Prior to the FDA's update, various lawsuits were filed by women who allegedly suffered side effects related to migration of the Implanon device.
In April 2015, Kayla Doherty filed a federal lawsuit Kayla Doherty v. Merck & Co. Inc. et al Case No. 1:15-cv-00129, US District Court, District of Maine against Merck & Co. Inc. in the US District Court of Maine, alleging that she gave birth to a healthy baby boy 18 months after a health care center staffer performed a procedure to insert the implantable birth control device into her arm.
When Doherty became pregnant, a nurse informed her that a clinic doctor believed that the device was never inserted, according to court documents. Both Implanon and the similar device Nexplanon have records of failed insertion attempts because of defectively designed applicators, according to Doherty's lawsuit.
Two other women also filed a lawsuit Brook Reynolds et al v. Merck Sharp & Dohme Corp., Case No. 3:15-cv-397, Northern District of Ohio, Western Division against Merck in March 2015, alleging that their Implanon devices migrated after insertion.
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