What is Implanon?
An estimated 500,000 women in the United States use the birth control implant Implanon, according to the U.S. Food and Drug Administration (FDA). The device is a small, toothpick-like implant that is placed in a woman’s upper arm just under the skin.
It consists of a single, rod-shaped implant containing the synthetic progestin etonogestrel, pre-loaded in the needle of a disposable applicator. Implanon is designed to prevent pregnancy for a three year period and must be inserted during a surgical procedure by a healthcare provider.
How Does it Work?
Implanon works in 3 ways:
- It stops the body from releasing an ovum (egg) every month (ovulation)
- It makes the mucus in the cervix (the entrance of the uterus) thicker, so sperm cannot get through
- It changes the lining of the uterus (womb)
What's the Problem With Implanon?
Some women have reported device migration in which surgical removal of the birth control implant becomes impossible, leading to life-threatening complications including ectopic pregnancy, blood clots, vascular damage and deep vein thrombosis. Ongoing lawsuits allege the manufacturers failed to warn women the devices could potentially migrate to other parts of the body.
Additionally, like other non-oral hormonal contraceptives, Implanon comes with an increased risk for blood clots like pulmonary embolism and deep vein thrombosis as much as 40%. These life-threatening clots can form in the legs, permanently damaging blood vessels and surrounding tissue.
Birth Control Device Side Effects
Our lawyers are accepting potential lawsuits on behalf of women who suffered the following side effects after using Implanon:
- Heart attack
- Blood clot
- Pulmonary embolism
- Deep vein thrombosis (DVT)
- Life-threatening cardiac events
According to the British Medical Journal, Implanon users may also have an increased risk of the following side effects:
- Vascular damage
- Pulmonary artery damage
- Device migration
- Stomach cramping/bloating
- Breast tenderness
- Hair loss
- Weight gain
- Vaginal irritation/discharge
Related Article: Symptoms of IUD Perforation
Implanon Blood Clots
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, the researchers found that using a subcutaneous contraceptive have a 40% 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 is left untreated.
Is Implanon Still on the Market?
Implanon continues to remain available on the U.S. market, although Nexplanon has been introduced as an alternative contraceptive device. Supposedly improving upon Implanon’s defects, the Nexplanon implant is designed with a barium rod.
This way, if device migration occurs, doctors can do a CT scan, X-ray, ultrasound, or MRI to locate and remove it. Because Implanon doesn’t include this feature, removing it from the body is considerably more dangerous.
Which Other Types of Birth Control Have Been Linked to Blood Clots?
- Essure Permanent Birth Control
Related: Paragard IUD Lawsuit
What are Implanon Lawsuits Alleging?
Plaintiffs in Implanon lawsuits allege that Merck didn’t warn them or their doctors about potential migration risks and how it could become irretrievable. Additionally, plaintiffs 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 the manufacturer briefly touches on migration and then has a separate section concerning insertion and surgical 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.
FDA Warning Label Update
In March 2016, the FDA updated the labeling of Implanon to include a safety warning that there have been reports of the medical device migrating from the arm to other parts of the body.
"There have been reports of migration of the implant within the arm from the insertion site, which may be related to deep insertion," the warning states. "There also have been post-marketing reports of implants located within the vessels of the arm and the pulmonary artery, which may be related to deep insertions or intravascular insertion. In cases where the implant has migrated to the pulmonary artery, endovascular or surgical procedures may be needed for removal."
Prior to the FDA's update, various lawsuits were filed by women who allegedly suffered side effects related to migration of the Implanon device.
In April 2015, Kayla Doherty filed a federal lawsuit in the U.S. District Court, District of Maine against Merck & Co. Inc., alleging that she gave birth to a healthy baby boy 18 months after a healthcare center staffer performed a procedure to insert the implantable device into her arm.
When Doherty became pregnant, a nurse informed her that a clinic doctor believed that the device was never inserted, according to court documents.
Implanon Migration Class Action Lawsuit
A birth control lawsuit has been filed against Merck and it’s subsidiary Organon, over allegations that Implanon can migrate through the body, becoming irretrievable and exposing women to an increased risk of potential side effects including blood clots.
In 2011, officials in the UK reported that nearly 600 women had indicated that they got pregnant after receiving Implanon. Similar concerns have been raised in the U.S. by women who have undergone the implant.
The Implanon class action lawsuit was filed by Plaintiffs Brook Reynolds, Robert Reynolds, Julie Reynolds, Jenni Akins, Major Akins and Ruby Ginns.
Brook Reynolds and her parents joined the lawsuit after Brook received an Implanon implant in her left arm in May 2012. In July 2014, when she went to have it removed, her physician was unable to locate it.
To date, the device has still not been located in Brook’s body and is therefore irretrievable, putting her at unavoidable risk for health side effects connected with the device roaming through her body, including ectopic pregnancy and vascular damage.
Similarly, Ruby Ginns and Jenni Akins who had implants inserted in 2012, outline virtually identical stories to those of Brook Reynolds.
According to the complaint, the women and their family members claim that the manufacturers failed to adequately warn that the devices could migrate and become irretrievable.
Specifically, the complaint asserts that Merck and Organon manufactured and designed a defective medical device, failure to warn, strict liability, negligence, fraud by concealment, fraudulent misrepresentation, breach of warranty, infliction of emotional distress, and loss of consortium. The lawsuit seeks both punitive and compensatory damages.
See all defective medical devices torts we've taken on.