This Week in Sex: Essure Implant off U.S. Market; Endometriosis Drug Coming

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This Week in Sex: Essure Implant off U.S. Market; Endometriosis Drug Coming

Martha Kempner

After years and thousands of complaints about the implant Essure, Bayer finally takes it off shelves. And the first new endometriosis treatment in a decade brings hope of pain relief.

This Week in Sex is a weekly summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

Contraceptive Pulled After Thousands of Complaints

Pharmaceutical giant Bayer announced last week that it was pulling its controversial contraceptive device, Essure, off the U.S. market after nearly 16,000 lawsuits. The company, however, suggests that its decision is based on declining sales due to “misleading information” on social media, not valid complaints.

Essure consists of two tiny coils made of a nickel alloy and a polyesterlike fiber. They are inserted into the fallopian tubes and cause scar tissue that blocks the tubes, thereby preventing sperm and egg from ever meeting. Essure was approved by the Food and Drug Administration (FDA) in 2002 and lauded as the only nonsurgical method of sterilization; women could have the procedure done in a doctor’s office without incision or general anesthesia.

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But problems emerged quickly. Between 2002 and 2017, 27,000 users have reported some negative effect to the FDA. In some, it failed to cause the scar tissue and left them unprotected from pregnancy. The FDA reports that the device can perforate the uterus or the fallopian tubes and travel to other parts of the body like the abdominal or pelvic cavities.

Other side effects listed on the FDA’s website include abdominal, pelvic, and back pain; headache; fatigue; weight changes; hair loss; mood changes; allergic reactions; joint or muscle pain; and muscle weakness. Some women who used the device claim that it caused other health issues including chronic pain, neurological problems, and even the development of autoimmune diseases like lupus and chronic fatigue syndrome.

Another issue: Because it was meant to be permanent, doctors were never trained in removal, which requires surgery of varying difficulty. With few doctors who could do the procedure, women who no longer wanted the device were often left with no or few options.

Advocates had put pressure on the FDA to pull its approval of the device with limited success. In 2016, the FDA agreed to put its strongest warning—called a “black box” warning—on it, which notes the possibility of serious side effects. This year, a follow-up decision required doctors and patients to sign a five-part checklist, acknowledging the potential risks before Essure could be inserted.

Despite this and claims filed by about 16,800 plaintiffs, the company stands behind its product. In April, Bayer spokesperson Steven Immergut told the New York Times: “We have experienced a decline in sales due to the broad dissemination of misleading and inaccurate information on social media that is influencing women’s choices.”

The FDA will continue to collect information on adverse side effects from users. But at the end of this year, Essure will no longer be available in the United States. It has already been taken off the market in Brazil, Canada, England, and France, among other countries.

New Pill Could Provide Relief to Those With Endometriosis

In better reproductive health news, the FDA announced approval of a new oral treatment for endometriosis, a condition that can make menstruation extremely painful. The new pill, which will be sold under the name Orilissa, has successfully reduced pain for participants in numerous clinical trials. But it comes with symptoms similar to menopause, including hot flashes and bone-density loss.

The American College of Obstetricians and Gynecologists estimates that one in ten women of reproductive age have endometriosis but many may not know they have it because it is often dismissed as regular menstrual pain. In the condition, uterine tissue grows outside the uterus—such as on the fallopian tubes, ovaries, bladder, or intestines, or in the space behind the uterus known as the cul de sac. Uterine tissue that grows outside the womb still thickens and fills with blood during the menstrual cycle, but it’s not shed through periods and that can trap a person in a cycle of escalating pain.

Those who have endometriosis often take the birth control pill, which can lessen menstrual flow and alleviate some of the pain. Others are given painkillers. More serious cases are treated with surgery to remove the tissue that has grown in the wrong place.

Orilissa is in a class of drugs known as gonadotropin-releasing hormone receptor antagonists. They work by controlling the hormones that tell the body to make estrogen. This interrupts the cycle that thickens the lining of the uterus. In studies, this has been shown to dramatically reduce the pain that people with endometriosis experience during menstruation, between periods, and during intercourse.

Orilissa is not the first drug to work this way, but by only partially blocking the production of estrogen, it appears to work as well but have fewer side effects. And, because it is an oral medication and not an injection, doctors can try different doses and patients can stop taking it if the side effects become a problem.

As with any new drug, there are still some unanswered questions about Orilissa. The long-term effects are not known since participants only took it for about a year. Furthermore, studies comparing the drug to a placebo found that those taking it felt relief, but no studies were done comparing those on the new drug to those taking painkillers.

Orilissa could be available in several months.

Sperm Counts Are Going Down. Should We Worry?

Last summer, researchers announced the results of a meta-analysis that sperm counts are dramatically reduced from where they were 40 years ago. According to a piece in Thursday’s New York Times Style section, this announcement concerned researchers, intrigued entrepreneurs, and outraged those in the so-called men’s rights movement.

The research, conducted by an international team, looked at 185 studies that included semen samples from almost 43,000 men in 50 different countries collected between 1973 and 2011. The results show that sperm count in Western men dropped by 50 percent during those four decades.

Researchers don’t know what caused the decrease in sperm counts, but other studies have suggested that exposure to cigarettes, alcohol, and chemicals—including phthalates, a group of chemicals in plastics—in utero may lead to reduced sperm count. Obesity and stress may also play a role.

Efforts to do more research on the apparent sperm-count decreases have been hampered by lack of funding, but men’s rights activists think they have the answer. Shockingly, they blame women. Rollo Tomassi, who runs a site called The Rational Male, called the study “a watershed moment” and told the Times that he saw it as proof that society was weakening men. Daryush Valizadeh, who runs the men’s rights site The Return of Kings, trotted out more alarmist language by labeling the situation “a biological crisis.”

While men’s rights bloggers were blaming women, birth control, and soy (apparently it’s always soy), entrepreneurs are trying to find a way to profit from men’s fear about this newfound bio-deficit. Companies have created at-home sperm count tests (that run anywhere from $50 to $500), and cryobanking services are popping up to suggest young men freeze their sperm while their swimmers are still plenty and speedy.

We here at This Week in Sex think all of this is an overreaction. As Dr. Peter Schlegel, the chair of urology at Weill Cornell Medicine and New York-Presbyterian pointed out to the Times: “If you had a decrease in sperm count in the 50 to 60 percent range, we would expect the proportion of men with severe male infertility to be going up astronomically. And we don’t see that.”

So, let’s calm down. Sperm count is fickle. It can be down one day and up the next after a good rest. Before anyone buys a $600 centrifuge or starts freezing their fellers, ditch the “tighty whities” and skinny jeans, cut down on alcohol, stop smoking (pot and cigarettes), and eat healthier.

Plus, we need some research to see what might be destroying sperm and whether it matters for fertility. We’re pretty confident that women and soy are not to blame.