Nexplanon (Page 5 of 8)

6.2 Postmarketing Experience

Adverse Reactions and Events from Postmarketing Study

Nexplanon Observational Risk Assessment Study (NORA)

A postmarketing prospective active surveillance study was conducted among 7,364 patients in the United States to characterize the frequency of insertion-, localization-, and removal-related events.

Implant Insertion

Insertion difficulty or an insertion-related event occurred in 2.6% of the study participants. The overall incidence of incorrect insertion (unrecognized non-insertion, partial insertion, and deep insertion), reported by healthcare professionals was 12.6 per 1,000 insertions (95% CI, 10.2, 15.5). Table 5 summarizes the types and frequencies of these incorrect insertions.

Table 5: Incorrect Insertion Types and Incidence Reported by Healthcare Professionals
Type of Incorrect Insertion Event Number of Events * Incidence per 1,000 Insertions (95% CI)
*
Total Insertion Procedures = 7,364
(Initially) Unrecognized Non-insertions 1 0.1 (0.0-0.8)
Partial Insertions 27 3.7 (2.4-5.3)
Deep Insertions 65 8.8 (6.8-11.2)
Injury to nerve or blood vessel 1 0.1 (0.0-0.8)
Implant located within muscle 2 0.3 (0.0-1.0)
Implant located adjacent to fascial tissue 56 7.6 (5.8-9.9)
Implant not palpable 6 0.8 (0.3-1.8)

Implant Removal

Implant removal information from both healthcare professionals and patients was collected for 5,159 patients (70% of the study population). Of these patients, data were available from healthcare professionals regarding 4,373 removal procedures. Healthcare professionals reported removal-related difficulties or complications in 1.5% of removal procedures. Table 6 provides a summary.

Table 6: Removal-related Events Reported by Healthcare Professionals
Removal Related Events Number of Events * Incidence per 1,000 Removals (95% CI)
*
Total Removal Procedures: N= 4,373
Limited to one event per removal procedure
Only local migrations within the arm reported
§
Other included fragmented or bent implants, patient-related issues, wound care required, two incisions required, and difficulty identifying end of device.
Any Event 60 13.7 (10.5-17.6)
Encased in Fibrotic Tissue 29 6.6 (4.4-9.5)
Implant Too Deep 11 2.5 (1.3-4.5)
Implant Migrated 6 1.4 (0.5-3.0)
Multiple Attempts Required 13 3.0 (1.6-5.1)
Other § 14 3.2 (1.8-5.4)

At the time of implant removal, eighteen implants (0.4% of all localizations or removals) were not palpable by the healthcare professionals. Of these eighteen, eleven were localized and removed, and one was localized but left in situ. Removal was not attempted for six non-palpable implants due to underlying health conditions, administrative problems, or unspecified reasons.

There were no reports of implants having migrated more than a few centimeters from the insertion site and no reports of implants localized at a site other than the arm. No neurovascular injuries were reported by healthcare professionals.

Adverse Reactions Reported by Patients

Table 7 provides a summary of adverse reactions reported by patients at the time of implant insertion and after removal.

Table 7: Adverse Reactions Reported by Patients at Implant Insertion and after Removal
Patient Reported Adverse Reactions At Insertion After Removal
N * Incidence per 1000 insertions (95% CI) N * Incidence per 1000 insertions (95% CI)
*
Total Insertion Procedures: N = 7,364
Limited to one event per woman
Based on 3,447 questionnaires
§
No blood clots were observed during the study
“Other” included localized or insertion site pain, soreness, tenderness, dermatological changes, itching, bruising, and infection , local migrations within the arm, and physical damage to the implant (e.g., fractured or bent implant).
Any Event 49 6.7 (4.9-8.8) 42 5.7 (4.1-7.7)
Pins and Needles/Numbness (arm/hand/fingers) 17 2.3 (1.4-3.7) 24 3.3 (2.1-4.9)
Severe Pain 10 1.4 (0.7-2.5) 11 1.5 (0.8-2.7)
Altered Strength/Movement 3 0.4 (0.1-1.2) 8 1.1 (0.5-2.1)
Injury to Blood Vessels or Blood Clots in Arm § 2 0.3 (0-1.0)
Other 22 3.0 (1.9-4.5) 18 2.4 (1.5-3.9)

In summary, this prospective active surveillance study showed that the frequency of insertion-, localization-, and removal-related events is consistent with results previously reported from clinical trials.

Adverse Reactions from Postmarketing Spontaneous Reports

The following additional adverse reactions have been identified during post-approval use of IMPLANON and NEXPLANON. It is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure because these reactions are reported voluntarily from a population of uncertain size.

Gastrointestinal disorders: constipation, diarrhea, flatulence, vomiting.

General disorders and administration site conditions: edema, fatigue, implant site reaction, pyrexia.

Immune system disorders: anaphylactic reactions.

Infections and infestations: rhinitis, urinary tract infection.

Investigations: clinically relevant rise in blood pressure, weight decreased.

Metabolism and nutrition disorders: increased appetite.

Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, myalgia.

Nervous system disorders: convulsions, migraine, somnolence.

Pregnancy, puerperium and perinatal conditions: ectopic pregnancy.

Psychiatric disorders: anxiety, insomnia, libido decreased.

Renal and urinary disorders: dysuria.

Reproductive system and breast disorders: breast discharge, breast enlargement, ovarian cyst, pruritus genital, vulvovaginal discomfort.

Skin and subcutaneous tissue disorders: angioedema, aggravation of angioedema and/or aggravation of hereditary angioedema, alopecia, chloasma, hypertrichosis, pruritus, rash, seborrhea, urticaria.

Vascular disorders: hot flush.

Complications related to insertion or removal of the etonogestrel implants reported include: bruising, slight local irritation, pain or itching, fibrosis at the implant site, paresthesia or paresthesia-like events, scarring and abscess. Expulsion or migration of the implant has been reported, including to the chest wall. In some cases, implants have been found within the vasculature, including the pulmonary artery. Some cases of implants found within the pulmonary artery reported chest pain and/or respiratory disorders (such as dyspnea, cough, or hemoptysis); others have been reported as asymptomatic [see Warnings and Precautions (5.1)]. In-patient surgical interventions might be necessary when removing implants associated with complications.

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