Nexplanon

Primary Indication

Nexplanon is primarily used for the prevention of pregnancy. It is a long-acting reversible contraceptive (LARC) that provides continuous protection without requiring daily, weekly, or monthly action from the user.

Typical Use Cases

This method of birth control may be appropriate for individuals who:

• Want a highly effective, long-term contraceptive method.
• Have difficulty remembering to take a daily birth control pill.
• Prefer a discreet form of contraception.
• Cannot use or choose to avoid estrogen-based birth control methods.

The implant is a small, thin, flexible rod that is placed just under the skin of the upper arm by a healthcare professional. While it is designed to remain effective for up to three years, it can be removed at any time by a healthcare provider if the user decides they want to become pregnant or switch to a different method. Fertility typically returns to previous levels shortly after the device is removed.

Mechanism of Action

Nexplanon works primarily by releasing a steady, low dose of the hormone etonogestrel into the bloodstream. This hormone is a progestin, which is a synthetic version of a hormone naturally produced in the body.

The implant prevents pregnancy through three main methods:

• Stopping ovulation: It prevents the ovaries from releasing an egg. If no egg is released, there is nothing for sperm to fertilize.
• Thickening cervical mucus: It increases the thickness of the mucus at the opening of the uterus. This makes it much harder for sperm to swim through the cervix to reach an egg.
• Thinning the uterine lining: It alters the lining of the uterus, which may prevent a fertilized egg from attaching to the uterine wall.

Common Side Effects

The most frequent side effect of Nexplanon is a change in menstrual bleeding patterns. This may include irregular bleeding, spotting between periods, heavier or longer periods, or the complete absence of a period. Other common side effects include:

• Headache
• Weight gain
• Acne
• Breast tenderness or pain
• Nausea
• Mood swings or nervousness
• Vaginal discharge or infection
• Stomach pain
• Dizziness

Insertion Site Reactions

Some people experience side effects at the location where the implant is placed in the arm. These typically include:

• Pain, bruising, or swelling
• Redness or itching
• Small amounts of scarring

Serious Side Effects

Though less common, serious side effects can occur. Seek medical attention immediately if you experience signs of the following:

• Blood clots: Symptoms may include sudden leg pain, swelling, chest pain, or shortness of breath.
• Severe allergic reactions: Signs include hives, swelling of the face or throat, and difficulty breathing.
• Liver problems: Symptoms include yellowing of the skin or eyes (jaundice), dark urine, or severe upper abdominal pain.
• Depression: Significant changes in mood or suicidal thoughts.
• High blood pressure: New or worsening hypertension.
• Implant migration: In rare cases, the implant may move from its original position or be difficult to remove.

Contraindications

Nexplanon is not recommended for individuals with certain medical conditions. These include current or past blood clots in the legs, lungs, or eyes; known or suspected pregnancy; liver disease or liver tumors; undiagnosed abnormal vaginal bleeding; or a history of breast cancer or other progestin-sensitive cancers.

Insertion and Migration Risks

The implant must be inserted and removed by a trained healthcare professional. Complications such as pain, bruising, or infection at the site may occur. In rare cases, the implant may migrate from the insertion site to other parts of the body, including the lungs or blood vessels. If the implant cannot be felt under the skin, imaging tests are necessary to locate it before removal.

Cardiovascular and Thromboembolic Risks

Hormonal contraceptives are associated with an increased risk of serious blood clots, heart attack, and stroke. This risk is significantly higher for individuals who smoke, especially those over age 35. The implant may need to be removed before scheduled surgeries or during periods of prolonged immobility to reduce the risk of clots.

Ectopic Pregnancy

If a pregnancy occurs while the implant is in place, there is an increased risk that it will be an ectopic pregnancy. This occurs when a fertilized egg implants outside the uterus, which is a medical emergency.

Additional Considerations

• Bleeding Patterns: Most users experience changes in menstrual bleeding, such as irregular cycles, prolonged bleeding, or no bleeding at all.
• Ovarian Cysts: Follicles in the ovaries may become enlarged during use, though these typically resolve without treatment.
• Depression: Individuals with a history of mood disorders should be monitored, as hormonal changes can impact mental health.
• Metabolic Health: The implant may cause slight decreases in glucose tolerance; individuals with diabetes should monitor blood sugar levels regularly.

Pregnancy

Nexplanon is used to prevent pregnancy and should not be used by individuals who are already pregnant. If pregnancy is suspected or confirmed while the implant is in place, it must be removed by a healthcare professional. While the device is highly effective, no contraceptive is 100% effective. Research into progestin-only contraceptives suggests that if pregnancy does occur during use, there is no known increased risk of birth defects.

Breastfeeding

Small amounts of the hormone in Nexplanon pass into breast milk. However, studies indicate that the implant does not significantly affect the production or quality of breast milk. Additionally, no negative effects on the health, growth, or development of breastfed infants have been observed in clinical studies. Healthcare providers typically recommend waiting until the fourth week after childbirth before inserting the implant if you are breastfeeding.

Available Forms

Nexplanon is provided as a radiopaque, hormone-releasing implant. It has the following characteristics:

• Form: A small, thin, and flexible plastic rod.
• Applicator: The implant comes pre-loaded in a sterile, disposable applicator used for insertion.
• Visibility: The rod is radiopaque, which allows healthcare providers to locate it using imaging such as an X-ray if necessary.

The implant is designed to be inserted just under the skin on the inner side of the non-dominant upper arm by a trained healthcare professional.

FDA Approval and Indication

The U.S. Food and Drug Administration (FDA) approved Nexplanon in 2011. It is indicated for use by females to prevent pregnancy. The implant is effective for up to three years, after which it must be removed and can be replaced if continued contraception is desired.

Regulatory History

Nexplanon is the successor to Implanon, which was first approved by the FDA in 2006. The newer version was designed with two primary regulatory and safety improvements:

• Radiopacity: Nexplanon contains a small amount of barium sulfate, making it visible via X-ray, CT scan, ultrasound, or MRI. This helps healthcare providers locate the device if it is not palpable under the skin.
• Applicator Design: The device is packaged with a pre-loaded applicator intended to reduce the risk of incorrect or deep insertion.

Provider Requirements

The FDA requires that healthcare providers who perform the insertion and removal of Nexplanon complete a specific training program. This requirement is intended to ensure the device is placed correctly and to minimize the risk of complications such as nerve or blood vessel injury, or migration of the implant.

Safety Monitoring

The FDA monitors the safety of Nexplanon through the FDA Adverse Event Reporting System (FAERS). While there is no boxed warning for this device, regulatory agencies have tracked reports regarding insertion site complications and the rare occurrence of the implant migrating to other parts of the body, such as the pulmonary artery or chest wall.

Timing of Removal

The Nexplanon implant must be removed by a healthcare professional no later than three years after it is inserted. It can be removed at any time before the three-year mark if you wish to stop using the contraceptive or if you want to become pregnant.

The Removal Procedure

Removal is typically a quick procedure performed in a doctor's office. The process generally involves:

• Cleaning the skin and injecting a local anesthetic to numb the area.
• Making a small incision at the end of the implant.
• Pushing the implant toward the incision and removing it with forceps.
• Applying a small adhesive strip and a pressure bandage to the site.

Locating the Implant

If the implant cannot be felt under the skin, it may be difficult to remove. In such cases, the healthcare provider may use imaging techniques such as ultrasound, X-ray, or MRI to find the exact location of the device. If the implant is located deep within the arm, a more complex surgical procedure may be required for removal.

Return to Fertility

The contraceptive effects of Nexplanon end immediately upon removal. Most individuals return to their previous level of fertility very quickly, often within days or weeks. If you wish to continue using Nexplanon, a new implant can be inserted through the same incision immediately after the old one is removed.