Women who used the birth control implant Nexplanon are filing lawsuits against its manufacturer over allegations the implant can cause serious side effects, including blood clots, heart attack and stroke.
The lawyers and attorneys at National Injury Help are investigating these cases from those injured by Nexplanon. If you or someone you love suffered complications as a result of Nexplanon, you may be entitled to financial compensation. There may be a class action lawsuit forming with substantial cash settlements from claims filed.
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What is Nexplanon?
Nexplanon is a type of long-acting birth control. It is a small, thin, flexible rod that is implanted under the skin on the inside, upper arm. It protects against pregnancy for up to 3 years and can be taken out at any time before the three years is up.
Nexplanon contains the synthetic hormone etonogestrel and is radiopaque. Radiopaque means it can be detected by X-rays and other similar radiation.
Is Nexplanon different from Implanon?
Yes. Nexplanon replaced Implanon when Implanon was discontinued in 2011. Nexplanon contains the same hormone as Implanon (etonogestrel), but unlike Implanon, Nexplanon is radiopaque. This means doctors can find the implant inside the body using X-rays or other imaging if it ever moves from its original location.
Nexplanon also comes with a modified applicator, which helps prevent doctors from implanting the rod too deep in the patient’s arm. Deep insertion can increase the risk that the rod will move from the original location.
Who makes Nexplanon?
Nexplanon is manufactured by Organon USA Inc., now a subsidiary of Merck & Co.
Organon was a Dutch pharmaceutical company originally acquired by Schering Plough for $14 billion in 2007.
Then in 2009, Merck acquired Schering-Plough for more than $41 billion and took Organon along with it.
Nexplanon Risks & Complications
Nexplanon has been associated with a number of possible side effects, some more dangerous than others. The most dangerous side effects of Nexplanon are related to blood clots.
Nexplanon Blood Clots
Nexplanon increases a woman’s risk for blood clots. If a blood clot forms in the veins and breaks off, it can lead to other life-threatening conditions, including deep vein thrombosis and pulmonary embolism.
Deep vein thrombosis occurs when a blood clot forms in one of the body’s main veins, usually in the legs. If that blood clot breaks off and travels to the lungs, it is called pulmonary embolism.
Blood clots can be dangerous if not treated and can lead to heart attack, stroke and even death.
Side Effects of Nexplanon
Women who use Nexplanon are at risk for a number of side effects, but those who smoke and are over 35 may have the highest risk.
Nexplanon side effects include:
- Blood clots (thrombosis)
- Deep vein thrombosis
- Pulmonary embolism
- Heart attack
- Weight gain
- Irregular or heavy menstrual bleeding
- Ovarian cysts
- Breast pain
- Infection, vaginal infections
FDA Warnings about Nexplanon
The U.S. Food and Drug Administration has updated the Nexplanon label numerous times over the years to warn of possible side effects. Some of these updates are listed below.
March 2016 – Risk of Migration
The FDA updated the Nexplanon label in March 2016 to add warnings about implant migration. The label now indicates that reports of migration in the arm have been reported and are usually due to “deep implantation.”
The FDA warned that the implant has been found in the vessels of the arm and even the pulmonary artery.
August 2015 – Risk of Thrombatic Events
The Nexplanon label was updated in August 2015 to warn of the risk of blood clots in the veins and arteries.
The FDA indicated it had received reports of pulmonary embolism, deep vein thrombosis, heart attack and stroke in women using Nexplanon. Some of the reports of pulmonary embolism were fatal.
Studies: Nexplanon & Blood Clots
A relatively recent study out of Denmark found a 40% increased risk of blood clots in women using Nexplanon for birth control.
The study, published in the BMJ in 2012, used four Danish registries to follow roughly 1.6 million women between 2001 and 2010. The women were between the ages of 15 and 49.
The study found that women using Nexplanon were at a 40% increased risk for blood clots compared to those not using hormonal birth control.
The study also found significantly increased risks for blood clots when using the vaginal ring and the patch.
Nexplanon & FDA Approval
Nexplanon was approved by the FDA in May 2011. It replaced the original etonogestrel implant Implanon. Implanon was approved by the FDA in July 2006, three years after it was submitted for approval.
Why did it take so long to get approved?
The clinical studies submitted to the FDA supporting the safety and effectiveness of Implanon were compromised.
Violations in Clinical Studies
Organon first submitted Implanon for approval in September 2003. At the time, Implanon had already been approved for use in Indonesia and parts of Europe.
But further inspections by European regulatory authorities of the clinical study sites revealed “irregularities in study conduct” that raised concerns about the quality of data.
Two of the six studies conducted in Indonesia were withdrawn because of “significant Good Clinical Practice (GCP) violations that rose to the level of fraud,” according to a letter sent to Organon by the FDA in June 2005.
Two additional studies conducted in Europe were also found to be in violation of GCP and prompted European officials to change the Implanon label to reflect new safety and efficacy concerns.
The FDA told Organon it could not approve Implanon based on the data from the compromised studies. The agency said Organon needed to either conduct new clinical trials or provide justification as to why its original studies were enough to warrant approval.
Organon conducted independent audits of its compromised sites, but the FDA said it still was not enough to warrant approval.
Then in January 2006, Organon submitted another application for approval of Implanon, which the FDA granted the following July.
Half of U.S. study participants drop out
It is unclear by the FDA’s July 2006 approval letter what exactly changed the agency’s mind and led it to approve Implanon for use in the U.S.
The original clinical studies of Implanon involved nearly 1,000 women from different sites around the world. About 330 of those included women in the United States.
Of the 330 U.S. women involved in the clinical studies, nearly half (48.8%) dropped out of the study early. According to the Implanon label, 36.1% of subjects dropped out because of adverse events, the most common being irregular bleeding.
Roughly 11% of all study subjects experienced bleeding irregularities that led them to drop out early, including frequent, heavy, or prolonged bleeding or spotting.
Another 6.1% of U.S. subjects dropped out because Implanon caused inappropriate laughing and crying, 2.4% dropped out due to depression and 2.3% dropped out due to weight gain.
Nearly 25% of all study subjects experienced headaches during the clinical trials, though only 1.6% of women dropped out because of it; 14.5% of women experienced vaginal infections during the clinical trials; and another 13.7% experienced weight gain.
Postmarket Approval Study required
The FDA required Organon to conduct a postmarket approval study as a condition of its approval.
The postmarket study is still ongoing, but is expected to be completed in 2018. The study was to include at least 5,000 women and would track adverse events related to insertion, removal and location of the device.
Nexplanon Lawsuits & Settlements
Lawsuits are being filed against Organon and its parent company Merck over the increased risk of certain complications caused by the birth control implant Nexplanon. These complications include blood clots, deep vein thrombosis, pulmonary embolism, heart attack, and stroke.
These are not class action lawsuits. Class actions are filed by one or more people on behalf of a large group affected in the same way by the same person or entity. If a settlement or verdict is reached, it is distributed equally among the plaintiffs in the suit.
Nexplanon lawsuits filed by National Injury Help are individual lawsuits. Even if they are certified as a mass tort or multidistrict litigation, any settlement or verdict reached is unique to each individual case.
The lawyers at National Injury Help are currently accepting Nexplanon cases in the following states:
Nexplanon Lawsuits in these States:
Alabama (AL), Alaska (AK), Arizona (AZ), Arkansas (AR), California (CA), Colorado (CO), Connecticut (CT), Delaware (DE), Florida (FL), Georgia (GA), Hawaii (HI), Idaho (ID), Illinois (IL), Indiana (IN), Iowa (IA), Kansas (KS), Kentucky (KY), Louisiana (LA), Maine (ME), Maryland (MD), Massachusetts (MA), Michigan (MI), Minnesota (MN), Mississippi (MS), Missouri (MO), Montana (MT), Nebraska (NE), Nevada (NV), New Hampshire (NH), New Jersey (NJ), New Mexico (NM), New York (NY), North Carolina (NC), North Dakota (ND), Ohio(OH), Oklahoma (OK), Oregon (OR), Pennsylvania (PA), Rhode Island (RI), South Carolina (SC), South Dakota (SD), Tennessee (TN), Texas (TX), Utah (UT), Vermont (VT), Virginia (VI), Washington (WA), Washington DC (DC), West Virginia (WV), Wisconsin (WI), Wyoming (WY)
Do I have a Nexplanon Lawsuit?
If you’ve been injured by Organon’s Nexplanon birth control implant, you may be entitled to financial compensation.
To see if you qualify for a case, contact the experienced lawyers at National Injury Help today. We are available 24 hours a day, 7 days a week to assist you and answer any questions you may have.
Nexplanon lawsuit claims and settlements page updated on 4/10/2019