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There is an assortment of ways to prevent pregnancy, but one highly regarded option is via a birth control implant. This type of set-it-and-forget-it solution seems foolproof, offering a long-term option for preventing pregnancy without having to remember to take a pill or use one-off types of contraception. However, there have been numerous problems connected with this type of device, and Nexplanon is no exception.
What is Nexplanon?
The birth control Nexplanon is a small, thin and flexible rod that is implanted under the skin of the inner, upper arm. The process is simple – the impacted area of the arm is numbed with an anesthetic, and then the implant is placed under the skin. The feeling is similar to that of a standard injection, and stitches are not necessary following the procedure.
Manufactured by Organon USA Inc., Nexplanon contains etonogestrel, a synthetic progestin hormone. Progestin slows down or stops the release of ova, and it also thickens the cervix’s mucus, preventing sperm from reaching the ova. The implant does not work toward preventing HIV or STDs, only pregnancy.
Nexplanon is also radiopaque, which means that it can be detected by radiation such as x-rays. The purpose of this is so that doctors can easily find the device inside the body should it move from its original location. And while patients hope this never happens, it is possible and has a known potential side effect.
Nexplanon is considered long-acting birth control. It’s intended to protect against pregnancy for up to three years, and it can be removed at any point before that three-year duration runs out. The implant should be removed by a trained nurse or doctor. A local anaesthetic is used during the removal process, and it should only take a few minutes to complete. A small cut is made in the skin, through which the rod is pulled out. Once it’s removed, the patient is no longer protected against pregnancy.
Nexplanon replaced the birth control Implanon when it was discontinued in 2011. While Nexplanon and Implanon contain the same hormone, Implanon was not radiopaque. Also, Nexplanon has a different applicator that prevents doctors from implanting the rod too deep; if the insertion is too deep, there’s a higher chance of the rod moving.
FDA Approval of Nexplanon and Implanon
In May 2011, the U.S. Food and Drug Administration approved Nexplanon.
Implanon was approved by the FDA in July 2006, but it took three years after submission to be approved. The reason approval took so long was because the clinical studies that were submitted to the FDA that were meant to support Implanon’s effectiveness and safety were compromised.
Implanon was first submitted by Organon for approval in September 2003. At that time, birth control had already been approved in parts of Europe, as well as Indonesia. However, further inspection in Europe found “irregularities” in the studies that raised red flags about how reliable the data was.
Two of the six Indonesian studies were withdrawn due to fraud-level violations. Two other studies from Europe were also found to have Good Clinical Practice violations, and officials were encouraged to change the product’s label to show those efficacy and safety concerns.
The FDA let Organon know that Implanon could not be approved due to those compromised studies. Organon was told to either hold new clinical trials or to justify why the original studies were legitimate enough for approval. While Organon conducted audits of the compromised sites, the FDA said it still wasn’t enough for approval.
In January 2006, Organon submitted a new application for Implanon approval, which was granted by the FDA in July, allowing for use in the United States. As a condition of the approval, Organon had to conduct a post-market study of 5,000 women to track the adverse effects of the device.
Health Risks of Nexplanon
There are several side effects associated with Nexplanon, ranging from mild to severe, and women who are over 35 years of age and/or who smoke are at the highest risk. The side effects include:
- Blood clots
- Breast pain
- Deep vein thrombosis
- Heart attack
- Irregular menstrual bleeding
- Ovarian cysts
- Pulmonary embolism
- Weight gain
One of the biggest risks of Nexplanon is developing a blood clot. When a blood clot forms in the vein and then breaks off, other life-threatening conditions can occur, like deep vein thrombosis and pulmonary embolism. Deep vein thrombosis is when the blood clot forms in the main vein, typically in the legs. Should the blood clot break off and travel to the lungs, it’s considered a pulmonary embolism. Left untreated, a blood lot can lead to a heart attack, stroke, or death.
Implanon’s original clinical studies included approximately 1,000 women from around the globe, and approximately 330 of them were from the U.S. Of the U.S. women, almost half dropped out early. A little over 36% of them dropped out due to adverse effects, including irregular bleeding. About 11% of all subjects also experienced irregular bleeding, causing them to drop out of the study early. Irregular bleeding included heavy, frequent, or prolonged spotting or bleeding.
About 6.1% of the U.S. subjects opted to drop out of the study because birth control caused inappropriate crying and laughing. Other causes for drop-outs included depression (2.4%) and weight gain (2.3%).
About one-quarter of all participants experienced headaches, but less than 2% dropped out due to them. Vaginal infection was experienced by 14.5% of the participants, and 13.7% of the women gained weight.
Warning Label Updates
The FDA has updated Nexplanon’s label several times to continually warn about its side effects. For example, in August of 2015, a label update warned about the risk of blood clots in the arteries and veins. According to the FDA, there were reports of deep vein thrombosis, heart attack, and pulmonary embolism, and some were fatal. In March of 2016, the label was updated again to warn about rod migration in the arm, usually because of too-deep implantation. According to the FDA, the rod has been found in the arm’s vessels and the pulmonary artery.
The Nexplanon Lawsuits
Side effects of Nexplanon may be rare, but since it’s an invasive procedure, it’s not unheard of for something to go wrong. If there is a problem with a Nexplanon implant, the issue will likely fall under medical malpractice, so you need a lawyer who specializes in that field to work on the case. Litigations for medical malpractice cases can be complicated and expensive.
Women who used Nexplanon have filed lawsuits against the manufacturer, Organon, and its parent company, Merck, claiming that the implant can cause major side effects, including:
- Blood clots
- Deep vein thrombosis
- Heart attack
- Pulmonary embolism
The Beaufort Clinic Case
A woman in Beaufort County in South Carolina was awarded over half a million dollars in a Nexplanon lawsuit. The woman claimed that she went into the Beaufort Clinic for what should have been a simple, routine procedure. In January 2014, the woman had the Nexplanon implant put into her arm at the clinic. However, according to the claim, the device was not placed properly, resulting in multiple visits to an area medical center, where the implant was eventually removed. According to the lawsuit, the woman had nerve damage in her arm, causing permanent injury. According to the South Carolina Insurance Reserve Fund, the case resulted in a $600,000 settlement.
Liability in Nexplanon Lawsuits
In a Nexplanon lawsuit, there are several possibilities regarding which person or entity could be held liable, including:
The Manufacturer of Nexplanon
The manufacturer could be held liable if the device was faulty. As an example, if the applicator didn’t function properly and resulted in injuries, the manufacturer could be at fault.
However, since there is a small (1%) chance of becoming pregnant even with the use of Nexplanon, it would be very difficult to prove that the hormone dosage was faulty should the patient become pregnant.
The Medical Facility
If the implantation site becomes infected shortly following the procedure, this could be considered a hospital-acquired infection and thus the fault of the medical facility. The patient would have to prove that they followed the recommended treatment steps and did not cause the infection to occur or worsen.
The Doctor or Nurse
If the doctor or nurse who performed the procedure did not follow proper medical procedures, they may be at fault. The doctor or nurse could also be held liable if they didn’t inform the patient of possible side effects or medication contradictions before the device was implanted. Also, the medical professional may be liable if the device did not implant correctly and was not checked or if there was a post-surgery injury that occurred because of device removal.
Frequently Asked Questions
Question: How is the implant put in the arm?
Answer: A local anesthetic numbs the area of the arm where the implant will be placed. The implant is then inserted under the skin of your inner, upper arm by a trained medical professional. The feeling is similar to having an injection, and the entire process should only take a few minutes. There’s no need for stitches following implantation.
Question: How is the Nexplanon implant removed?
Answer: Nexplanon must be removed by a doctor or nurse. The medical professional will make a tiny cut in the skin that the rod can be pulled through. It’s common for a local anesthetic to be used.
Question: Do medications affect Nexplanon?
Answer: Certain medicines can make the implant less effective against pregnancy. For example, medications used to treat epilepsy, HIV or tuberculosis can have this effect, as can remedies like St. John’s wort and certain antibiotics. If you’re taking any of these medications, it’s recommended that you use an additional type of contraception or a different kind of contraception that’s not affected by medication. Your doctor will also be able to guide you on what is and is not affected by Nexplanon.
Final Thoughts About Nexplanon Lawsuits
The hope is that a majority of women who use Nexplanon or other forms of birth control will never experience the severe yet rare side effects that could occur. However, for those who do, there may at least be legal help and monetary compensation available. If you feel like you may have a Nexplanon lawsuit on your hands, it’s best to contact a medical malpractice attorney who can guide you through your next steps.
Cochran Law: Who Can Be Held Liable for Injuries Caused by a Birth Control Implant?
National Injury Help: Nexplanon Lawsuit Claims and Settlements
NHS: Contraceptive Implant, Worries, and Questions
WIS News: SC Woman Receives 6-Figure Payout in Birth Control Implant Lawsuit