Implantable birth control device could fracture, users are warned
The Food and Drug Administration has issued a startling label change for Nexplanon, the only implantable birth control device approved in the U.S. The device can fracture, with shards potentially migrating from the location of implantation.
The product’s insert — in the Warnings and Precautions section — previously read, “Cases of breakage or bending of implants while inserted within a patient’s arm have been reported.” New, additional language, current as of Sept. 29, says: “Cases of migration of a broken implant fragment within the arm have also occurred. These cases may be related to external forces, e.g., manipulation of the implant or contact sports.”
Within the Adverse Reactions section, an edited sentence now reads, “Some cases of implants migrating to the pulmonary artery presented with symptoms of chest pain and/or respiratory disorders (e.g., dyspnea, cough or [ coughing up blood]); other cases have been reported as asymptomatic,” though it’s unclear whether this language is related to the new discussion of broken or migrated implants.
The FDA approved Nexplanon in November 2011 for the prevention of pregnancy for up to three years. The progestin-only product is about the size of a matchstick and is inserted just under the skin on the inner side of a woman’s non-dominant upper arm.
With no daily pills to remember and an over 99% success rate measured at one year, it’s an attractive birth control option. Irregular bleeding was the most common adverse reaction in clinical trials ( 11.1%), though Nexplanon can be removed at any time, for any reason.
Previously, the product insert disclosed that some devices had been found within the blood vessels of the arm and pulmonary artery, conditions that may have been related to improper placement of the device.
“I’ve been doing this for 14 years, and I have never seen that happen,” said Dr. Michelle Harvison, chair of OB/GYN at St. Clair Health. “I think for practitioners who insert them often and who are experienced … well,
we’ve never had this happen in my office.”
The recent labeling changes are the first mention of contact sports being a risk factor for migrating or broken devices. For Dr. Harvison, that information will result in a few extra minutes of discussion with patientathletes interested in Nexplanon, but will not alter her practice.
“Because of the irregular bleeding, Nexplanon is not one of my favorite birth controls in general, so I generally don’t push for it,” she said. “But if that’s what a patient really wanted and she understood the risks — that they’re low but still a possibility — then I would be OK giving it to her.”