The Implanon birth control device is a small, thin plastic rod that is inserted under the skin to prevent pregnancy. The plastic rod slowly releases etonogestrel into the body over a three-year period. Etonogestrel is comparable to a natural hormone made in the body and does not contain estrogen. It functions mainly by preventing the release of an egg during the menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching the egg and changes the lining of the uterus, or womb, to prevent attachment of a fertilized egg. The product does not contain estrogen, according to WebMD.
Implanon Birth Control Background
In 2007, the U.S. Food and Drug Administration (FDA) approved Implanon birth control, the implantable device that can last up to four years (officially three years on-label). Twelve years prior to that, a research paper told of the difficulty in removing the six capsules that were part of a Norplant implantable birth control system. From 1994 to the present day, a period of 23 years, concern has been raised over such implantable devices. The problem focusing on difficulty involved in removal of the device and the potential for device migration.
Implanon Benefits and Complications
The Implanon birth control is one of the more recent devices FDA approved for long-term, low maintenance birth control. The implantation of a device in the upper arm below the skin which is designed to dispense protection from unwanted pregnancy, has been touted as a convenient method for women from having to remember to take a daily pill, or use other less-convenient birth control methods.
The problem that has been alleged in many Implanon birth control personal injury lawsuits, is the difficulty in locating, then removing the spent device at the end of its life cycle. In rare cases, the device has travelled from the initial insertion site during the three to four years the device is in place. Even more rare, are documented cases where a device has been found far from the original insertion point, for example, in a blood vessel of the lung, whereby the device could not be located, reports the manufacturer.
Product liability attorneys at Parker Waichman are actively reviewing potential lawsuits regarding medical devices including the Implanon birth control device.
Merck & Co., the manufacturer, a subsidiary of Organon, has since brought out Implanon NXT and Nexplanon, and update and alleged improvement on the original Implanon device. The update is the added benefit of barium sulfate added to the core of the device. Barium sulfate is visible on X-rays, thus aiding clinicians in locating a device that may be difficult to find.
In March 2016, the FDA mandated a warning label update with regard to the rare potential for device migration. Despite the complications and problems associated with Implanon, the FDA has not been convinced sufficiently that the device should be removed from the market and deems the implantable device as safe and effective.
A Specific Implanon Problem
Despite the rare complications associated with the Implanon implantation, it is not infallible. A young woman from Bangor, Maine, received an implantable birth control in 2013 following a recommendation from a community health clinic. Some 18 months later, with the birth control device still active with less than half of its life cycle, the woman tested positive and gave birth to a child, making the woman a single mother. The plaintiff launched a consumer fraud lawsuit alleging wrongful birth. In addition, clinicians despite repeated attempts, could not locate the failed birth control device.
The paper states, “A case study was presented of one woman who asked for removal of the six small Norplant capsules (2.4 mm x 34 mm) that were inserted subdermally, radially in the medial portion of the upper arm, per standard protocol. The obstetrician made a surgical incision and removed easily five of the capsules, but could not locate the last one by digital probing. The patient was then referred to a hospital radiology department.”
The paper continues,“ The first action taken was a radiograph, which revealed a faint visualization. The second picture was taken with real time sonography, but the capsule could not be visualized. A third action was a computed tomography of multiple thin (3 mm) slices, but again there was no success in locating the missing capsule. The final attempt was to use intermittent fluoroscopy and persistent probing, which revealed the locale and led to successful removal of the last capsule.”
It required four attempts to locate, and remove the elusive sixth Norplant capsule. Wyeth, the manufacturer, withdrew the Norplant device from the market six years later in 2000. There were reportedly numerous lawsuits concerning the product.
It was six years after that, that the FDA gave the approval to Implanon, with no reference to the rare potential for device migration until ten years later, the spring of 2016.
Legal Advice and Information Regarding Implanon
If you or someone you know suffered injuries associated with the Implanon birth control device, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).