Implanon Device Migration

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. By Gordon Gibb

Washington, DC  You may not have heard much about Implanon birth control previously. But you will, given the emergence of an Implanon birth control personal injury lawsuit that’s been filed as a class action. The issue in the current lawsuit is device migration. But there can be other issues as well.

Implanon Device Migration: “Where the Heck Is It?”First, a refresher as to exactly what Implanon is: an implantable birth control device, small and thin akin to the size of a toothpick, that’s inserted below the skin in the upper arm and designed to provide birth control protection through the measured release of the progestin etonogestrel for about three years before removal. Various advocates of the device claim that it can last as long as four years – but three years is the recommended window.

It’s one of the latest examples of the so-called ‘set-it-and-forget-it’ line of devices that does not require the ingestion of a daily birth control pill, or the management of a dermal patch that requires changing at regular intervals. For busy women prone to forget their birth control pill, the automatic dispensary option is viewed with some favor. The US Food and Drug Administration (FDA) approved Implanon, marketed by Merck & Co., in July of 2006.

After ten years on the market, it has been reported that some 500,000 women use the device for birth control.

However, lawsuits are beginning to emerge. Co-plaintiff Brook Reynolds, who joined the class action Implanon birth control personal injury lawsuit, alleges that the Implanon device she received in 2012 migrated away from the initial implantation site. In 2014, when Reynolds attended her doctor’s office to have the device removed, her physician was unable to locate it.

The toothpick-sized device had migrated away from the original implantation site. Other plaintiffs cite remarkably similar issues to those of Brook Reynolds. Co-plaintiffs Jenni Akins, Major Akins, Ruby Ginns, Robert Reynolds and Julie Reynolds allege that Merck & Co. and subsidiary Organon failed to warn of the potential for migration.

There is, indeed, little mention – if any – about the potential for device migration by way of information generally available to consumers. The Contraceptive Technology Update (06/01/16) carried a report that lauded the effectiveness of the implantable Implanon and its successor, Nexplanon, in terms of effectiveness. While common side effects were outlined, there was no mention of the potential for device migration.

In another example, Planned Parenthood on its website includes more common Implanon birth control side effects – as well as less-common side effects – but makes no mention with regard to the potential for device migration. Under the heading of ‘Serious Side Effects of the Birth Control Implant’ Planned Parenthood lists as the last item, “tell your health care provider immediately if the implant comes out or you have concerns about its location.” Device migration is not mentioned. Reference to ‘concerns about its location’ is subject to interpretation.

It is not until we look to Merck.com before we get any sense as to the possibility of device migration. In a downloadable pdf document intended for consumers, there is references made at the bottom of a bullet listing of common side effects – but is not part of the active list.

“Implants have been reported to be found in a blood vessel including a blood vessel in the lung.”

And,

“Implants have been found in the pulmonary artery (a blood vessel in the lung). If the implant cannot be found in the arm, your healthcare professional may use imaging methods on the chest. If the implant is located in the chest, surgery may be needed.”

Downloading a document intended for doctors and healthcare providers reveals more information – specifically with regard to guidance for the removal of a spent implant, which is normal after a few years. The Implanon is meant to be retrieved at the end of its useful life cycle:

“Confirm that the entire implant, which is 4 centimeters long, has been removed by measuring its length. There have been reports of broken implants while in the patient’s arm. In some cases, difficult removal of the broken implant has been reported.

“There have been reports of migration of the implant; usually this involves minor movement relative to the original position [see Warnings and Precautions (5.1)] (original reference), but may lead to the implant not being palpable in the location in which it was placed. An implant that has been deeply inserted or has migrated may not be palpable and therefore imaging procedures, as described below, may be required for localization.

“Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged.”

This is a dilemma faced, in particular, by Brook Reynolds, according to the Implanon birth control consumer fraud lawsuit to which she belongs. When Reynolds attended her doctor to have the device removed, her physician was not able to locate it. Presumably, diagnostic imaging was unsuccessful in locating the device and thus, the location of the Implanon remains a mystery. As suggested by the manufacturer’s dissertation to doctors noted above, exploratory surgery is not recommended without first knowing where the device is. In Brook’s case, without knowing where the device is, surgery appears out of the question.Thus, the Implanon originally received by plaintiff Brook Reynolds appears to be irretrievable. The continued migration of the toothpick-sized object could subject her to Implanon birth control personal injury, including ectopic pregnancy and potential damage to her vascular system – not to mention her peace of mind, living daily without a clear picture of where this thing is.

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