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Essure Not a Sure Thing

For people with a uterus who want permanent contraception, Essure seemed to offer many benefits. The device, which is put into the Fallopian tubes to create scar tissue and prevent pregnancy, can be placed at a doctor’s office without anesthesia or a hospital stay. Unfortunately, the device’s popularity was held back by horror stories about side effects. Now, a new study confirms that patients with Essure are more likely to need an reoperation compared to those who chose to have their tubes tied with surgery.

A few good benefits and some major risks.

The study used data from over 50,000 patients treated in New York state between 2005 and 2013. Of these, only 8,000 had Essure placed. In addition to avoiding anesthesia and the hospital, those with Essure also had a lower risk of major medical complications 30 days after it was placed. The risk of unintended pregnancy is the same for both permanent options.

Unfortunately that’s where the good news ends. Essure is an average of $2000 more expensive. And patients with it were 10 times more likely to need a reoperation later on compared to those who had surgery. This difference held steady even after adjusting for age and other health problems.

An outcome patients care about.

The study is the first to look at Essure’s safety as it relates to the need to undergo surgery. Though the study did not examine reasons behind patients’ choices, we can speculate that many wanted to avoid surgery for either personal reasons or medical one such as obesity or scarring from previous abdominal operations.

Like all research, this one has its flaws.

The overall rates for reoperation are still pretty low at 2% compared to surgical sterilization’s 0.2%. Additionally, because the study used medical record data, we don’t know the purpose of the reoperations. Were they for a serious problem or second attempts to place the device? Lastly, Essure patients are supposed to come in for a three-month follow-up, unlike those who get their tubes tied. This means that it’s easier to discover problems since a surgical patient may not see their doctor again until their next annual visit or if a problem arises.

Nevertheless, for patients who want to avoid surgery, this data provides one more variable to consider when choosing the right type of sterilization for them. This is especially true since surgery after Essure failure can be riskier than the minimally invasive surgical sterilization would have been.

Adding to the controversy

The study comes at a particularly heated time as the FDA met at the end of September to reexamine Essure’s safety and effectiveness. Meanwhile Congress submitted a bill to have the device’s pre-market approval pulled. If passed, Essure would be unavailable within 60 days.

The increased risk of reoperation is not the only thing concerning the governmental bodies. Other unusual side effects, including pain, heavy or irregular periods, and fetal death in people who became pregnant after Essure was placed, were reported by over 5000 individuals since the device launched in 2002. Lastly, new data from Bayer, the device’s maker, came out earlier this year showing strong concerns about Essure’s safety.

What’s ironic about this whole situation is that if the device had been researched more thoroughly and improved as necessary, it could have been more popular, helpful, and profitable. Everyone would have benefited. Unfortunately, we know that both the FDA’s regularly processes and research paid for by a medical device or drug’s manufactur is problematic. Both of these come into play with Essure but only time will tell if they, along with some relatively small numbers of people with complications, are enough to pull it from the market.

Other Sexual Health News This Week

HHS to Include Sexual Orientation & Gender Identity in Meaningful Use of Electronic Health Program (Human Rights Campaign)

Sobering Results from Real World HIV Treatment Analysis (Medpage Today)

ATIXA: Schools Must Protect LGBT, Gender Non-Conforming Students from Harassment (Campus Safety Magazine)

Closure of Women’s Health Clinics Due to Government Cuts Affects Preventative Health (News Medical)

TSA Dropping the Term ‘Anomaly’ For Transgender Passengers (The Hill)

Affordable Care Act Coverage Improves Chances of Viral Suppression for Americans with HIV (AIDSMap)

No News Good News? HIV Rates Stable Among US Adults

Are public health efforts to beat HIV in the U.S. coming to fruition? Not quite, but the HIV rate among US adults is stable.  National survey data show that between 2007 and 2012, the rate dipped slightly but not significantly. This is despite the fact that just over half of respondents were in one or more high-risk behavior groups.

This information comes from the most recent  National Health Statistics Report and uses data from over 10,000 Americans ages 18-59 who completed the National Health and Nutrition Examination Survey (NHANES) between 2007 and 2012. The slight decrease in overall HIV prevalence is likely the result of multiple factors including but not limited to:

  • Approval of PrEP and the subsequent health promotion campaigns surrounding it
  • Improved ability via technology and other tools to reach the individuals most at-risk for HIV

Age, race, and gender matter.

Besides the overall HIV rate, the report also looks at key risk factors and prevalence of antiretroviral drug (ART) use among adults with HIV. They found that age, gender, race, STI status, and sexual risk-taking all impact who gets HIV. Specifically, someone is more likely to be HIV-positive if they are older, male, or non-Hispanic black. These correlations aren’t particularly surprising given the lack of condom use among older Americans and the distrust of the healthcare system reported by many blacks.

Other factors associated with HIV infection included being in one of the following high-risk groups:

  • having herpes simplex virus type 2 or a history of another STI
  • sleeping with 10 or more people in their lifetime
  • same sex sexual contact among men

Here again, the report doesn’t offer any new information but rather supports the idea that so-called risky sexual behavior puts individuals more at risk for all STIs, including HIV.

The researchers also found a few things that did not affect the HIV rate. These include education, poverty index ratio, or current health insurance status. This provides an interesting counterpoint to the social-political narrative of the poor, uneducated, uninsured, and “living off the system” person who has HIV. Even more interesting is the lack of news coverage about this result.

ART use remains low.

While the steady rate of HIV is promising, the news around treatment is less so. Only about half of adults with HIV report using ART in the past month.  And the exact numbers were extremely small, making this data highly unreliable. ART use was higher among non-Hispanic whites, men, and those with health insurance. ART use also increased with age and was more common among those in one or more high risk groups.

2007-2012 was the first year adults over age 49 were included in the NHANES.

Some people are getting tested, though.

Most of those with HIV have a history of being tested for it outside of blood donations but less than half of adults without HIV can say the same. Testing rates were higher in men, MSM, those with a history of an STI, and those with five or more lifetime sexual partners.

This last correlation is particularly exciting because it shows improvement in sexual health care by providers and/or patients. It’s impossible to know whether these individuals are self-selecting for more routine testing or if their healthcare providers are encouraging testing based on taking a full sexual history. Either way, this is good news because it shows that health care providers and patients are taking more responsibility for sexual health.

Though this is likely outside the abilities of the NHANES it would be fascinating to perform some qualitative studies looking at the conversations the different subgroups have with their sexual partners. Are the risk takers who get tested having the talk more? Who’s initiating the conversation? Is this more or less than individuals who report less sexual risk taking? Answers to these questions could help public health professionals better address concerns people express about having such conversations.

Education, not shame

As public discourse around STIs becomes more nuanced, the question is how can we as a field make a significant dent in the HIV rate without shaming those already diagnosed and/or who are sexual risk takers. It’s a tricky balance. Those who didn’t grow up during the AIDS crisis, and who don’t study it as most of us do, lack a certain fear of HIV that can push them to make less risky sexual decisions. On the other hand, fear-based campaigns don’t work and ultimately add to the sexual shame that prevents people from being honest about their sexual histories (check out the story below) and getting the testing and treatment they need.

Obviously getting rid of HIV isn’t so simple as answering this question There are clear connections to socioeconomic status, race, and other forms of oppression that make it more difficult for certain people to access the information, tools, and treatment that could help them more fully assess what risks they’re willing to take and then live with the potential outcomes of those risks. And of course, there’s a lack of funding for comprehensive sex education and a lack of states that require even medically accurate HIV education.

Figuring out how to navigate this more nuanced, balanced approach to HIV education and messaging is just one piece of the larger puzzle. However, it’s something we should begin studying sooner rather than later, along with novel ways of getting our messages to the highest risk groups, so that in the next Report (or maybe the one after that), the news will be significantly more positive.

Other Sexual Health News This Week

Millions More Need H.I.V. Treatment, W.H.O Says (New York Times)

Billboards Linking Tinder to STDs are Latest Battleground in Online Dating Wars (Washington Post)

Men May Underreport Male Sex Partners at Time of HIV Testing (Medscape)

Beauty or Beast? Why Perceptions of Attractiveness Vary (Live Science)

California Mandates New High School Lessons to Prevent Sexual Assaults  (LA Times) This is part of their new mandated sex education for grades 7-12 (EdSource).

Lawmaker Works to Add Gender Identity to [Wisconsin] State Law (Channel 3000)

What the Updated National HIV/AIDS Strategy Means for Black America (Indianapolis Recorder)