Informed Consent: NuvaRing
Informed Consent: NuvaRing
NuvaRing (etonogestrel (11.7mg) and ethinylestradiol (2.7mg) + ethylene vinyl acetate copolymer (EVA/plastic) + magnesium stearate) is a contraceptive ring that is inserted vaginally, which became available in 2001.
What it is: NuvaRing is a brand name for the first vaginal contraceptive ring. The ring is inserted vaginally, and remains for 3 weeks, before it is removed for one week. Then you must replace with a new ring. The ring is made of non-biodegradable, flexible ethylene vinyl acetate copolymer, a form of EVA (you may have seen shower curtains that use the material PEVA, it is similar.) This contraceptive vaginal ring contains a synthetic progestin and ethinyl-estradiol. In 2018, a generic version of NuvaRing, called ANNOVERA, became available. The ANNOVERA ring is slightly different, it lasts for one year instead of a new one every month, but similarly the ring is typically removed for one week after three weeks of constant use.
How it prevents pregnancy: The ring works mainly through ovulatory suppression. When wearing the ring inside the vagina, your body absorbs the steroid drugs ethinyl estradiol and etonogestrel progestin into your bloodstream. These drugs halt gonadotropin release which is essential to and responsible for starting the process of ovulation. Without the egg release during ovulation, you cannot become pregnant. The ring also thickens cervical mucus, blocking the entryway for sperm in the reproductive tract. It may also thin the endometrial lining.
Failure rate: Typical use: 9% (or 91% effective IRL) Perfect use: 1% (or 99% effective in clinical trials)
Ovulation preserved?: No, the mechanism of action is mainly ovulatory suppression.
Side effects: Tissue irritation inside the vagina or on the cervix, irregular bleeding or spotting, headaches and migraines, mood changes, nausea and vomiting, weight gain, vaginal discharge and discomfort, breast pain, breast discharge, breast discomfort or tenderness, painful menstrual periods, abdominal pain, acne, blotchy darkening of the skin especially on the face, high blood sugar, and high cholesterol and triglycerides in the blood.
Mental health effects: Low libido, mood swings, anxiety, depression
Serious physical health risks: Blood clots, including double the risk of deep vein thrombosis and pulmonary embolism, heart attack, stroke, and loss of eyesight. Per NuvaRing’s website “It is possible to die or be permanently disabled from a problem caused by a blood clot, such as heart attack or stroke... The risk of getting blood clots may be greater with the type of progestin in NuvaRing than with some other progestins in certain low-dose birth control pills. The risk of blood clots is highest when you first start using CHCs and when you restart the same or different CHC after not using it for a month or more.” Other health risks include toxic shock syndrome, with symptoms such as high fever, vomiting, diarrhea, sunburn like rash, muscle aches, dizziness, or fainting. Allergic reactions including hives, swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (anaphylaxis and/or angiodema) are possible. Additionally, high blood pressure problems, gallbladder problems, and accidental insertion into bladder are other risks.
Symptoms of serious physical health risks: Early signs of a blood clot, heart attack, or stroke include leg pain that doesn’t go away, sudden shortness of breath, sudden blindness (partial or complete), severe pain or pressure in your chest, sudden and severe headaches, weakness in the arms and legs or trouble speaking, and yellowing of the skin or eyeballs.
Who shouldn’t use NuvaRing: Anyone with a history of thrombophlebitis or thromboembolic disorders, deep vein thrombophlebitis, cerebral vascular or coronary artery disease, valvular heart disease, severe hypertension, diabetes with vascular involvement, headaches with focal neurological symptoms, major surgery with prolonged immobilization, known or suspected carcinoma of the breast or breast cancer, undiagnosed genital bleeding, cholestatic jaundice of pregnancy, hepatic tumors, known or suspected pregnancy, heavy smoking, or hypersensitivity to any of the components like EVA plastic.
Body systems that may be impacted: 11/11 systems. Cardiovascular system, digestive system, endocrine system, exocrine system, immune system, muscular system, nervous system, reproductive system, renal system, respiratory system, skeletal system.
How long it should be used for: In order to mitigate serious health risks, NuvaRing should be used for less than 5 years, though it is commonly used for longer.
Can NuvaRing suppress my period? Yes NuvaRing is sometimes used for menstrual suppression as well by skipping the ring-removal-week. There is no data to whether this is more or less safe than the protocol of removing the ring once monthly for a week.
Other facts about NuvaRing
The steroid drugs in NuvaRing will take several days to dissipate from your bloodstream, even after the ring is removed.
The risk of serious adverse events from using NuvaRing increases the older you are and the longer you use it.
NuvaRing And Blood Clot Death Controversy:
In 2011, Erika Langhart died at 24 years old of two heart attacks in her apartment due to using NuvaRing. She had a blood clot that had started in her artery/vein of her right thigh and traveled to her lungs causing massive pulmonary embolisms and multiple episodes of cardiac arrest. After her sudden death, her parents, Karen and Rick Langhart, became activists who wanted to warn women of the dangers of hormonal contraceptive drugs. They have denounced the $100 million dollar settlement (an average of $58,000 per plaintiff) that Merck offered to resolve about 3,800 lawsuits in federal and state court regarding the potentially lethal side effects of the drug. Under the class action settlement agreement, Merck gets to deny any fault. The settlement was determined because 95% of the 3,800 eligible plaintiffs agreed to the settlement terms.
“Shame on them,” Rick Langhart said. “This settlement agreement, orchestrated by Merck and the attorneys on both sides, driven by their own greed, has all but eliminated the chance for Merck to be taken to trial.” “We are truly devastated. It appears that, from a legal standpoint, Merck is literally going to get away with murder,” he said. “If the settlement is successful, Merck is simply going to get away with all of their wrongdoings for what is, to them, a small price to pay for ‘doing business,’” Karen Langhart wrote in an email.
Erika Langhart’s Case for Wrongful Death was dismissed on September 10, 2015 because her family refused to settle with Merck. That year the company made over $700 million in profits. You can listen to their live interview on CNN here.
The story was also covered in Vanity Fair. The story also covered a similar scare for Megan Henry, a trained athlete in high-speed downhill sledding who was training for the Olympics in 2012 when NuvaRing caused her to collapse during training and she was unable to breathe. Doctors confirmed she had multiple blood clots in both her lungs (pulmonary embolisms).
"There are other options out there for birth control that have risks, but not doubling the risks, If I would have known that I never would have taken it." Henry told CNN.
Why Is NuvaRing More Dangerous Than Other Types of Birth Control?
Many epidemiology studies show that third generation oral contraceptives, including those containing desogestrel (etonogestrel, the progestin in NuvaRing, is the biologically active metabolite of desogestrel), are associated with a higher risk of venous thromboembolism than certain second generation oral contraceptives. These studies indicate an approximate two-fold increased risk (from 3x more likely to 6x more likely).
It’s commonly touted that the steroid drug release from implants, IUDs, the patch, and the ring are more smooth and stable across time than while using oral contraceptives. However, this represents an averaging of hormone levels over time (to which there can be large and dangerous spikes in hormone levels), and the average concentration of synthetic hormone is 60% higher in the ring than compared with using a pill with the same hormones. So it’s not due totally to the method of application but also due to dosage, one of three factors in assessing birth control risk. Therefore, the birth control ring should be considered a high-risk contraceptive product, along with other first, third, and fourth generation drugs. The safest birth control contains 2nd generation drugs such as levonorgestrel or norgestimate.
^ Figure 1. This is an example of the data we see, real time serum levels are much more variable than they appear here
Why Don’t We Know About This? How True Statistics Are Hidden in Pharma Funded Research.
Even though the study out of Copenhagen showed a two times higher increase of clotting compared to earlier forms of second generation contraceptives, and a 2012 study published in the British Journal of Medicine showed a 90% increase in the likelihood of suffering venous thromboembolism with the ring than those with earlier form of progestins, the FDA decided to use a different study that the pharmaceutical company itself had funded, which only showed three times risk (the generally accepted standard risk on all forms of combined contraceptives).
The truth is that drug companies are funding studies on their own products and the FDA works together with them to decide how they will be marketed.
Big Pharma is able to manipulate the data available for their advantage through the use of averaging. For example, the information you see on a patient information packet is based on the *averaging* of several study cases. Therefore, alarming parts of the data can be hidden through shifting data points and re-averaging the results. This type of data manipulation helps pharmaceutical companies get their products approved quickly, with less regulatory oversight. One example of this is that the ring is typically known for giving a “steady” stream of hormones throughout the month, despite raw data showing that this is an averaging, and many people in clinical trials experienced deep spikes throughout the entire use of the device.
In addition, Merck was able to use a study funded by the FDA that was published only on new users of NuvaRing. This is what became the information that is on the package insert. This has led people to repeat the incorrect assumption that your risk of an adverse event is only higher when you first start using NuvaRing. The reality is that people have adverse events sometimes several years after first using the device. The raw data exists which can prove this, but this is always conveniently hidden from public view and not utilized by regulators.