Here’s something more to feed the fire.
Nexplanon, the contraceptive implants in the thick of the controversy over their use in the United Kingdom in under-16 schoolgirls has many side effects, many of them serious.
Common adverse reactions of using Nexplanon, technically known as non-radiopaque etonogestrel implant, reported in clinical studies sponsored by the drug’s manufacturer, Organon, include the following:
- Pain— headache (1 in 4 of women who had the implant reported this), breast pain (1 in 8 women), abdominal pain (1 in 10), dysmenorrheal (1 in 14), back pain (1 in 16) and pain in the insertion site (1 in 20), Influenza-like symptoms (1 in 14) and unspecified pain (1 in 20)
- Infection—vaginitis (1 in 6), leucorrhea or white vaginal discharge (1 in 10) and pharyngitis (1 in 10)
- Emotional or mental problems like emotional lability (1 in 16), nervousness (1 in 20), depression (1 in 20) and hypersensitivity (1 in 20)
- Undesirable outcomes like weight gain (1 in 6) and acne (1 in 6), dizziness (1 in 14) and nausea (1 in 16)
Clinical trials involved 942 women and were done to evaluate the safety and efficacy of the implant.
Changes in menstrual bleeding patterns
Having Nexplanon implanted can cause changes in bleeding patterns, ranging from amenorrhea or total disappearance of the menstrual cycle (1 in 5 women) to frequent or prolonged bleeding (1 in 5 women).
In clinical studies, at least ten percent of women who had Nexplanon implanted chose to have it removed specifically because they found it unbearable to be bleeding for more than half a month—clinical study results note an average bleeding of 17.7 days of bleeding or spotting every 90 days.
Nexplanon implant is inserted subdermally in the upper arm and failure to insert the implant properly can pose many risks. If implanted too shallowly, it will not work as a contraceptive. This may go unnoticed and lead to an intended pregnancy.
What’s worse is that a pregnancy that occurs in a woman using Nexplanon is more likely to be ectopic than a pregnancy occurring in a woman using no contraception.
Failure to insert Nexplanon properly may go unnoticed and may lead to an unintended pregnancy.
Complications related to insertion and removal procedures, such as pain, paresthesias, bleeding, hematoma, scarring or infection, may occur.
Deep insertions, on the other hand, may cause the implant to migrate and get lost. Removing the deeply inserted implant will require a surgical procedure in an operating room because this should be done with care to prevent injury to deeper nerves or veins and arteries in the arm. Failure to remove the implant may result in compromised fertility or ectopic pregnancy.
Such grave problems can be avoided by making sure that the implant is inserted by a healthcare provider. But even so, many women (1 in 13) report pain and other implant site reactions like erythema, hematoma, bruising and swelling.
Thrombotic and other vascular events
All combination hormonal contraceptives (progestin plus estrogen) are known to increase the risk of what doctors call “vascular events,” including arterial events like heart attacks and stroke or deep venous thrombotic events like a venous thromboembolism or a blood cut in a deep vein that can break off and travel to your lungs and eyes.
Nexplanon is not a combination hormonal contraceptive, but a progestin-only contraceptive, and it’s unknown whether its use increases the risk for these dire events.
The drug’s label, however, advises the careful assessment of women who have a higher risk for venous and arterial thromboembolism.
Indeed, there have been postmarketing reports of serious arterial and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, heart attack and strokes in women using the non-radiopaque etonogestrel implant.
The implant’s label reads: “If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. On rare occasion, surgery may be required.”
This is apt to be a big disappointment for many: average weight gain of those using Nexplanon was 2.8 pounds after one year and 3.7 pounds after two years — high rates that will surely contribute to a creeping increase of weight that may lead to obesity.
Using Nexplanon may contribute to a depressed mood, and the drug’s label specifically urges that women with a history of depression should be observed carefully.
The side effects that women in clinical trials found most unbearable were bleeding irregularities, emotional instability, weight gain, headache, acne and depression.
Postmarketing side effects
Additional side effects were identified during post-approval use of Nexplanon.
Reported voluntarily by women “from a population of uncertain size,” it’s not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Complications related to insertion or removal of the non-radiopaque etonogestrel implant reported include: bruising, slight local irritation, pain or itching, fibrosis at the implant site, paresthesia or paresthesia-like events, scarring and abscess.
Pregnancy, puerperium and perinatal conditions: ectopic pregnancy.
Reproductive system and breast disorders: breast discharge, breast enlargement, ovarian cyst, pruritus genital, vulvovaginal discomfort.
General disorders and administration site conditions: edema, fatigue, implant site reaction, pyrexia.
Infections and infestations: rhinitis, urinary tract infection.
Psychiatric disorders: anxiety, insomnia, libido decreased.
Nervous system disorders: convulsions, migraine, somnolence.
Renal and urinary disorders: dysuria.
Metabolism and nutrition disorders: increased appetite.
Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, myalgia.
Gastrointestinal disorders: constipation, diarrhea, flatulence, vomiting.
Investigations: clinically relevant rise in blood pressure, weight decreased.
Skin and subcutaneous tissue disorders: (aggravation of) angioedema and/or aggravation of hereditary angioedema, alopecia, chloasma, hypertrichosis, pruritus, rash, seborrhea, urticaria.
Vascular disorders: hot flush.