Washington, DCIt’s been 10 years since Implanon birth control, the implantable device that lasts up to four years (three years on-label), was given formal approval by the US Food and Drug Administration (FDA). Twelve years before that, a research paper described the difficulty in extracting the six capsules inherent to a Norplant implantable birth control system. Over the intervening time from 1994 to the present day, a period of 23 years, concern has been raised over such implantable devices, the difficulty involved in device removal and the potential for device migration.
Why does the FDA continue to approve such devices? Various women, who allege Implanon birth control consumer fraud, may be asking that same question. One plaintiff alleges wrongful birth, after becoming pregnant.
Implanon birth control is one of the more recent devices approved for long-term, low maintenance birth control through the implantation of a device in the upper arm below the skin designed to dispense protection from unwanted pregnancy while rescuing the user from having to remember to take her daily pill, or change a birth control patch.
The problem – one that has been alleged in many an Implanon birth control personal injury lawsuit – is the difficulty in locating, then extracting the spent device at the end of its life cycle. In rare cases, the device has migrated away from the original insertion site during the 3-4 years the device is in place. More rare still are documented cases where a device has been located far from the initial insertion point – such as in a blood vessel of the lung, according to the manufacturer – or whereby the device could not be located.
The manufacturer, Merck & Co. through their subsidiary Organon, has since brought out Implanon NXT and Nexplanon, an update on the original Implanon device with the added benefit of barium sulfate added to the core of the device. Barium sulfate shows up on X-rays, and thus aids clinicians in locating a device that may be hard to find.
Problems associated with Implanon, albeit rare, have been insufficient to persuade the FDA to mandate a removal of the implantable devices from the market. Even though the regulator mandated warning label updates this past March with regard to the rare potential for device migration, the FDA nonetheless deems the implantable devices as safe and effective.
However, they are not infallible as one Implanon birth control consumer fraud lawsuit asserts. According to court documents, Plaintiff Kayla Doherty, a young woman from Bangor Maine, received one of the implantable birth control devices early in 2012 following a recommendation she received from a community health clinic.
Some 18 months later, when the birth control was still robust with less than half of its life cycle used, Doherty tested positive for pregnancy and subsequently gave birth to a child, making Doherty a single mother. Clinicians, in spite of repeated attempts, could not locate the device.
Doherty launched an Implanon birth control personal injury lawsuit (Doherty v. Merck & Co., Inc. Case No. 1:15-cv-129-DBH, in US District Court, District of Maine), alleging wrongful birth.
Meanwhile, 20 years before the birth of Doherty’s child, a paper published in February, 1994 described difficulty in locating, and removing all six capsules involved with the now-defunct Norplant device.
“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 paper states. “The obstetrician made a surgical incision and removed easily 5 of the capsules, but could not locate the last one by digital probing. The patient was then referred to a hospital radiology department. 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 took four attempts to locate, and remove the wayward 6th Norplant capsule. The manufacturer, Wyeth, withdrew the Norplant device from the market six years later, in 2000, reportedly while facing numerous lawsuits over the product.
Six years after that, the FDA gave the nod to Implanon, with no reference to the rare potential for device migration until the spring of 2016 – ten years later.
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