Implanon Lawsuits

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The market for implanted forms of birth control, which then release hormones over an extended period, has existed since the 1990s. Following earlier options like Norplant, Implanon got approval in 2006, offering an improvement over the multi-stick concept used a decade earlier.

Implanon, just the size of a toothpick or matchbook, gets placed under the upper arm’s skin. Over a three-year period, it releases progestin etonogestrel, a synthetic hormone, to prevent pregnancy. Although it can continue releasing hormones beyond this timeframe, doctors then remove it at this point and offer patients the option of switching to an alternative birth control device.

But, based on multiple reports, Implanon doesn’t always stay in place, instead migrating through the body and essentially becoming irretrievable. When this occurs, the device, which now requires surgical removal, exposes patients to a list of side effects, both from its migration and continual release of hormones. In response, patients have started filing lawsuits against manufacturer Merck and its subsidiary Organon, alleging the companies didn’t do enough to warn them and medical professionals about these life-threatening side effects.

Background

Starting in 2011, roughly 600 women in the U.K. reported that they became pregnant while using Implanon, and similar concerns soon followed in the U.S.

By the next year, patients started coming forward when physicians claimed they couldn’t find the device at the three-year mark. When the device starts migrating through the body, pregnancy is still possible, as are other long-term or life-threatening side effects, including:

• Ectopic pregnancy
• Vascular damage, including after it migrates to blood vessels and the lungs
• Infertility

With these reports, plaintiffs now filing lawsuits allege the manufacturer didn’t warn them or their doctors about potential migration risks and how it could become irretrievable. In fact, they further claim, they were told the birth control was completely reversible.

Patients could have learned about these risks if they read Merck’s official website, where, deep in a document about Implanon’s potential side effects, the manufacturer briefly touches on migration and then has a separate section concerning insertion and removal. Here, Merck mentions that surgery could be required to remove Implanon and, that when it remains in the body, its effects may be felt over a longer period of time.

In response to patients’ complaints, the FDA has since required Merck to update its warning label. As of 2016, statements about migration and potential surgical removal now accompany the drug.

But, while patients have been coming forward, Implanon’s issues follow one of its predecessors, Norplant, a similar form of birth control manufactured by Wyeth Pharmaceuticals. Removed from the market in 2000, Norplant had six rods that needed to be retrieved, all of which could migrate within the patient’s body. In 1995, a study highlighted the drug’s potentially life-threatening risks.

Implanon continues to remain on the market, although Nexplanon has been introduced as a better alternative. Supposedly improving upon Implanon’s defects, Nexplanon is designed with a barium rod. This way, should the device migrate, doctors can do a CT scan, X-ray, ultrasound, or MRI to better locate and remove it. Because Implanon doesn’t include this feature, removing it from the body is considerably more dangerous.

Migration isn’t the only concern patients should have. A 2012 study published in the British Medical Journal found that non-oral forms of birth control, like Implanon, have a greater incidence of blood clots. In fact, data indicated, those using a subcutaneous contraceptive have a 40-percent greater risk of developing this condition, compared to those who don’t use any form of hormonal contraceptive. From a blood clot, a patient may develop deep vein thrombosis, pulmonary embolism, a heart attack, stroke, organ damage or failure, or a permanent disability or could die if the condition’s left untreated.

Lawsuits

Currently, about 500,000 women use Implanon as their birth control. While the risks for migration are relatively small, what results is a life-altering condition that’s only reversible through a surgical procedure.