When Will Women Have Truly Risk-Free Birth Control?
Here’s why controversial birth control healthcare needs to start putting women first, not financial gain.
In June of 1960, the FDA approved the sale of the first birth control pill, Enovid. Though effective and simple to use, Enovid was far from perfect. Due to the extremely high dose of hormones it carried (far more than necessary to prevent pregnancy), the likelihood and severity of side effects were sky high. Even more disturbing was the fact that these serious side effects had been evident since the first clinical trials.
In the first trials in Puerto Rico, Dr. Edris Rice-Wray reported early on that 17 percent of the women* who took the pill had significantly unpleasant side effects, including dizziness, nausea, headaches, and vomiting. Because of the discomfort caused by the medicine, 25 of the patients withdrew from the trials before completion. In her first report, Dr. Rice-Wray made it known that although the pill provided exceptional protection against unintended pregnancy, she felt it caused too many side effects to be generally acceptable.
Unfortunately, Gregory Pincus, the head of the research team, was more concerned with the pill’s effectiveness at preventing pregnancy than the side effects — he had little empathy for what he regarded as hypochondria among the women in the trials. But it wasn’t hypochondria at all. Besides the distressing side effects mentioned above, one woman died of congestive heart failure and another developed pulmonary tuberculosis. The trial researchers were so focused on watching for damage to the cervix, endometrium, liver, and ovaries, that they didn’t stop to consider that these adverse reactions were related to the pill.
Once the pill hit the market, the problems only intensified. Reports of nausea, breast tenderness, water retention, and weight gain poured in from millions of women worldwide. In 1961, G.D. Searle — the manufacturer of Enovid — reported 32 incidents of thrombosis (blood clots) and embolism (clots moving through and blocking a blood vessel) among women using the pill. But the FDA resolved that even if the pill caused these harmful side effects, the rate was much lower than the rate of women who would die from pregnancy complications.
However, Senator Gaylord Nelson elected to hold hearings on whether the women who used Enovid had been provided with enough information about possible risks and side effects to make an informed decision. Some who questioned the use of the pill were motivated by an interest in women’s health. Some, such as Hugh Davis, were not. Davis, a gynecologist, was Nelson’s lead speaker at the hearings. He testified that women would be safer using a new IUD instead of the pill. He failed to reveal the fact that he had a financial interest in promoting this new IUD — the Dalkon Shield — which was later found to cause pelvic inflammatory disease, loss of fertility, and the death of five women. This wasn’t the first time profits were put ahead of women’s safety, and it wouldn’t be the last.
As a result of the Nelson Pill Hearing, drug companies were required to include a health warning with oral contraceptives — the first informational insert on any prescription drug. Enovid was discontinued in 1988, and oral contraceptives were released with far lower estrogen doses.
The history of the birth control pill is a disturbing one, and unfortunately, it doesn’t seem to have had any impact on the modern pharmaceutical industry. If we look closer at the birth control options available for women today, we’ll find that not much has improved in the last 57 years.
Good Enough Doesn’t Cut It
As it stands, no birth control currently available on the market is risk free — even those that are generally considered safe. Hormonal birth control (pills, patches, vaginal rings, injections, and implants) is known to cause headaches, nausea, sore breasts, and spotting between periods in many women. Much worse, though, is the increased risk of blood clots, heart attack, stroke, and liver tumors. Women who smoke, especially if they are over 35 years of age, are especially susceptible to these serious side effects.
For the most part, progestin-only birth control doesn’t carry these risks. Women who are over 35 years of age and smoke should avoid birth control containing estrogen. Women of any age should avoid combination hormonal birth control if they have a history of uncontrolled high blood pressure, chest pain, diabetes, severe headaches, heart or liver disease, blood clots, or stroke.
Intrauterine devices (IUDs) are one of the most effective forms of birth control. However, they shouldn’t be used if you have an active STI, have had a recent pelvic infection, have had cancer of the cervix or uterus, or if you’re pregnant. Rare but serious side effects include infections caused by bacteria getting into the uterus when the device is inserted, punctures in the wall of the uterus, ovarian cysts, and ectopic pregnancies. Copper-releasing IUDs can cause intense cramping, longer and heavier periods, and spotting between periods.
Even permanent birth control isn’t totally safe. Surgical sterilization (tubal ligation) typically involves general anesthesia and a laparoscopy. Major complications of tubal ligation aren’t common, but include infection, heavy blood loss, general anesthesia problems, and organ injury during surgery.
Invented to be an alternative to surgical sterilization, Essure is the latest birth control option found to cause serious harm to the women who use it. Essure is a permanent birth control procedure that involves two nickel-titanium coils being placed inside the fallopian tubes to incite the growth of scar tissue that eventually blocks the tubes to prevent pregnancy.
Many women who have used Essure report the implant having migrated and embedding itself elsewhere in the body, chronic fatigue, migraines, joint pain, digestive issues, back pain, heavy periods full of clots, difficulty concentrating, abdominal pain, pelvic pain, hair loss, tooth deterioration, depression, and severe bloating. These problems have been so severe that hundreds have needed surgery to remove the device — a surgery that often ends in a complete hysterectomy.
Bayer, the maker of Essure, failed to properly carry out clinical studies, and actually petitioned the FDA to downgrade the nickel contraindication to a “warning” — which resulted in physicians not screening patients for nickel allergies. Consequently, many users had severe autoimmune reactions to the device.
The Essure scandal — which is still very much ongoing — has led the FDA to require that Bayer label the device with the agency’s strictest “black box” warning. This alerts both patients and doctors to the risks associated with Essure. Furthermore, Bayer has to develop and conduct a new post-market study to investigate the rate of complications including injuries, pain, unplanned pregnancies, and surgery to remove the device.
Is The Future Of Birth Control Male?
The effect of modern birth control on women’s bodies has led many to look to new options for men** as a possible solution. As it stands, men have only two choices for birth control: condoms or a vasectomy. Both these methods come with their own issues and limitations. Fortunately, there are a number of male contraceptives currently in development, the most promising of which is Echo-V, a hydrogel created by contraceptive company Contraline.
The Echo-V gel is injected directly into the vas deferens (the tube that transports sperm from the testes to the urethra) where it solidifies and blocks the flow of sperm — but still allows other fluid to pass through. When the patient is ready to have children, a solution is injected to dissolve the gel. The doctor uses an ultrasound to guide the placement of the injection, so no surgery or stitches are required.
Clinical trials in India have shown that the hydrogel method works with almost perfect results and no serious side effects. However, tests will still need to be carried out in America, and Contraline has had trouble finding financial backing. It may be a while yet before Echo-V is available.
Though contemporary birth control is safe for most women, everything currently on the market is still associated with some risks and side effects. And, with the controversy surrounding contraceptives such as Yasmin, Mirena, and now Essure, we are constantly faced with the question of whether those in the healthcare field can truly balance ethics with financial responsibility.
Our best bet is to do as much research as possible before choosing which birth control is right for us. Other than that, we’ll just have to look to the future.
* Not all women have a womb.
** Not all men have a vas deferens.
Artwork: Brittany Naundorff (brittanyfears.com)