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Spangenberg Shibley & Liber LLP | Jun 17, 2016

Side Effects of Implanon and Nexplanon Birth Control

Categories: Product Liability, Medical Malpractice, Defective Drugs and Medical Devices

According to the U.S. Food and Drug Administration (FDA), the birth control implants Implanon and Nexplanon, made by the pharmaceutical company Merck & Co., Inc., are reportedly at risk of migrating from the initial insertion site, causing complications that may require surgical removal of the device.

Nexplanon is a popular small, soft, and flexible contraceptive implant placed under the skin of the upper arm. It works by slowly releasing etonogestrel, a synthetic hormone, over three years. Etonogestrel thickens the cervical mucus, affects changes in the endometrium, and inhibits ovulation in women. It is intended to prevent pregnancies over the three years it is in effect.

Implanon/Nexplanon was first approved by the FDA in 2001, but these most recent safety label changes regarding migration only recently went into effect in March of this year. According to recent reports, the implants have been found in the pulmonary artery, within the vessels of the arm, and in the chest wall. Surgical or endovascular procedures may be needed in order to remove the implant when it migrates to the pulmonary artery.

The FDA warns that surgically removing the Implanon or Nexplanon implant may cause damage to deeper vascular or neural structures in the arm, but failing to do so could also result in continued effects of etonogestrel. These continued effects could lead to the occurrence or persistence of an adverse side effect, including ectopic pregnancy and compromised fertility.

Along with the possible migration of the implant, the FDA warns that Implanon and Nexplanon can become damaged or break in the patient’s arm, impacting the release rate of the etonogestrel and causing further complications.

The FDA also warned consumers in August 2015 that, “… There have been post-marketing reports of serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel implants. Implanon and Nexplanon should be removed in the event of a thrombosis.”

The recently-added warning in March 2016 marked the fourth additional warning released by the FDA since May 2014, only adding to the list of increasingly dangerous side effects. Nexplanon, now used by hundreds of thousands of women in the U.S., was approved as an improved version of Implanon. It is detectable through x-rays or CT scans, which allows medical professionals to detect the implant and ensure it is correctly placed. It also comes with a new preloaded applicator, which is intended to reduce the risk of implantation errors by making the process easier.

With an ever-increasing list of side effects, consumers should be cautious if they are considering getting the implant, and consumers who already have the implant may want to consider meeting with their doctor in order to make sure it hasn’t migrated or become damaged.

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