In Contraceptive Tech, the Apps Guess Is as Good as Yours

Last year, a small Swedish startup made waves with what it called the world's first form of "digital contraception." The company's product, a smartphone app called Natural Cycles, pairs with a thermometer to track women's basal temperature every day, then uses that data to make predictions about ovulation. Rather than curbing ovulation, like an oral contraceptive, Natural Cycles gives women either a red light or a green light on unprotected sex depending on when they're most likely to be ovulating. The app promised a 21st-century update to contraception—one that used algorithms, not hormones; one that lived on an iPhone, not inside of a woman's body.

That promise is now under investigation, after a hospital in Stockholm reported last week that 37 out of 668 women seeking abortions since September had used Natural Cycles as their primary form of contraception.

That's just one hospital, in one city. The app reportedly counts over half a million subscribers across 160 countries. Chances are, more than just a few dozen women in Stockholm have been failed by the app and others like it.

The report from Stockholm is interesting because last year, Natural Cycles became the first app to be certified as a contraceptive in Europe. It raised millions of dollars in investments during a moment when interest in consumer health technology is staggeringly high. So the fact that women are reporting unwanted pregnancies from Natural Cycles already, not even a year after its certification, is not just alarming. It's a miner's canary for a much larger constellation of contraceptive technology.

The Algorithm Method

Before there was Natural Cycles, there was Clue, Ovia, Kindara, and dozens of other apps for charting one's fertility. Some of these apps look like digital calendars of menstruation: They provide a space on a woman's smartphone to log periods and track cycles over time. Others use period tracking, as well as data like basal temperature, to predict ovulation and suggest windows of peak fertility (for women trying to get pregnant) or low fertility (for women trying to avoid pregnancy).

"All these apps are really souped-up rhythm methods."

Reproductive clinician Mary Jane Minkin, also known as Madame Ovary.

It's true that ovulation is cyclical, and tracking data over time can help a woman predict when she's most likely to conceive. At best, apps like Natural Cycles give women space to log their own bodily rhythms and understand when they're most likely to get pregnant. At worst, they take folkloric advice about how to not get pregnant and make it seem more credible by dressing it up as a smartphone app.

"All these apps are really souped-up rhythm methods," says Mary Jane Minkin, a practicing gynecologist and reproductive clinician at the Yale University School of Medicine. "The term for the technique was known for years as 'Vatican roulette.' And the old joke was: 'What do you call women who use the rhythm method? Mothers.'"

Even still, it's not hard to find reasons why women would find a cycle-tracking app appealing. The burdens of contraception are high, and fall largely on women. Hormonal options can wreak havoc on the body, causing all kinds of unpleasant side effects. Without insurance, birth control pills are expensive, and often out of reach for young or low-income women. IUDs can be painful, condoms can be uncomfortable, emergency contraception can be fallible. So it's forgivable that a natural method—something that requires little more than monitoring your own body and downloading an app—seems appealing. Consider the group of women New York Magazine once called "the pull-out generation"—young females fed up with hormonal birth control and interested in understanding their bodies more deeply. Those women gave rise to an ecosystem of apps that claimed to hold all the information—and not just information, but technology, right there on your smartphone—needed to master one's own body.

It's an age-old impulse. Women have practiced "natural" family planning methods for as long as women have been fertile, as a way to avoid pregnancy when contraception wasn't attainable or easy to use. Today, the same methods are just dressed up with technology. Natural Cycles doesn't just follow the days of your period, but your temperature too! Other apps look at hormone levels, or vaginal mucus. Pair all that with an inviting design and a tab that cites research studies, and you've got something that looks more like science and less like folklore. When a technological solution is presented to us, we're more willing to give it the benefit of the doubt.

Quantified Fertility

Natural family planning, and apps that support the method, do have some credibility. Last September, Natural Cycles was the focus of a major study on natural contraceptive methods. The study followed 22,785 women through a total of 224,563 menstrual cycles and found that the app was 99 percent effective at preventing pregnancy during "perfect use," and 93 percent effective during "imperfect use"—roughly on par with hormonal birth control and barrier methods like condoms.

With any gadget or app that relies on self-reported data, the margin for human error is extremely high.

The study results were followed by a surge of $30 million in Series B funding for Natural Cycles. But much of the hype surrounded the success from "perfect use," rather than "typical use." The expectation that women will reliably input data, or even collect that data accurately, on a daily basis in the app seems unlikely. Moreover, the app relies on slight variations in temperature to predict ovulation, but is still finding ways to take into account the many factors that can affect a woman's temperature—sleeping habits, sickness, mood. The app can suggest when a woman is most likely to be ovulating, but cannot accurately warn when ovulation comes a few days early. And, with any gadget or app that relies on self-reported data, the margin for human error is extremely high.

Minkin says the collected data in these apps can be tremendously useful for women who are hoping to get pregnant. But using them as contraception "depends on your acceptance of risk." The exact day of ovulation can be unpredictable—even with a log of past cycles, temperature measurements, and hormone levels—and that can make it difficult to know which days are safe to have unprotected sex. "Very few people consistently ovulate every cycle on day 14," says Minkin. "If you happen to ovulate on day 12 and you've had sex two days earlier, those sperm are going to be around. All you need is one guy hanging around and you're pregnant."

In a statement to WIRED, a spokesperson from Natural Cycles wrote that "no contraception is 100 percent effective, and unwanted pregnancies are an unfortunate risk with any contraception." The goal of the app, the spokesperson said, is to provide greater contraceptive choice to women who wouldn't otherwise be using contraception at all. "At first sight, the numbers [of unintended pregnancies] mentioned in the media are not surprising given the popularity of the app and are in line with our efficacy rates. We have initiated an internal investigation with our clinical department in order to confirm this. As our user base increases, so will the amount of unintended pregnancies coming from Natural Cycles app users, which is an inevitable reality."

For any type of birth control, "typical use failures are significantly higher for any method that involves timely intervention from the user," says Aparna Sridhar, an obstetrics and gynecology clinician at UCLA. That's why IUDs are less likely to fail than a birth control pill, and a birth control pill is less likely to fail than a natural planning method.

More information can certainly be useful: Women who track their menstrual cycles, basal temperature, or hormonal levels over time might have a clearer picture of their fertility than women who don't, and mapping out the expected days of ovulation can decrease the likelihood of conception. But as with so many health-focused apps, wearables, and devices, that information can only go so far. Relying solely on a smartphone app to prevent pregnancy might be like wearing a Fitbit to prevent a heart attack. The data can offer valuable information. But information alone can't change the outcome.

Correction appended 11-19-2018 at 2:15 PM EST: This story was updated to include a statement from Natural Cycles.

High-Tech Hype

Read more: https://www.wired.com/story/natural-cycles-contraceptive-apps/

My vagina was badly injured after giving birth. Why was getting help so hard? | Christen Clifford

My vagina tore when I had my first child, but it took five years before I got the medical attention I needed. Im not the only one

Every time I see a woman walking down the street with a newborn, all I can think is, Does she have a traumatized vagina?

My vagina tore when I had my first child. Doctors Id never met before sewed me up and refused to tell me how many stitches theyd put in. I healed, and when I had another child five years later, I tore in the same place.

My midwives sewed me up and told me everything looked fine, but I noticed certain changes: it was next to impossible to hold in flatulence. Constipation became a painful and humiliating constant. I leaked urine when I sneezed no matter how many kegels I did. And it felt like the physical angle of everything having to do with evacuation and intercourse had somehow shifted after childbirth in new and uncomfortable ways. I felt like my vag was broken. That something was wrong.

Five years later, I started seeing a new gynecologist, who listened, examined me, and said, Oh, yep, youve got a little rectocele in there.

A what?

She told me that a rectocele occurs when the muscle between the rectum and vagina is so worn and thin that the rectum kind of pops out into the vagina.

I felt angry. Why hadnt a single health professional, many of whom had examined me thoroughly, bothered to diagnose it? Well, its within the range of normal, so we usually dont mention it.

I went home and searched for more information. The National Institutes of Health says, Rectoceles are common and involve a herniation of the rectum into the posterior vaginal wall that results in a vaginal bulge. Women with rectoceles generally complain of perineal and vaginal pressure, obstructive defecation, constipation, or the need to splint or digitally reduce the vagina to effectuate a bowel movement.

Splinting? Digital reduction? These are the medical terms for what I knew through anecdotal evidence was common practice: one friend must insert a finger into her vagina to release the stool from her rectum every time she defecates. Another said she always pressed into her perineum when relieving herself. Another friend, with a rectocele and a cystocele, splints and takes vast quantities of psyllium seed husk to stay regular.

Me? Once, I was doubled over in pain, so dehydrated and constipated that I took the plastic gloves out of a box of NiceNEasy haircolor because, well, it wasnt. After I had dug out the feces that had become trapped in the small pocket of my rectum that protruded into my vagina, I was shocked, silent, humiliated.

Even with my excellent health insurance, after giving birth the only medical attention I received was a quick six-week checkup. After learning about my rectocele, I went to see a pelvic floor specialist. She told me that because my rectocele was small and the risks were high, I was not a candidate for surgery.

She explained pelvic floor exercises, recommended I eat a lot of fiber and suggested double evacuation when urinating. Pee, then stand up and move from side to side, then urinate again so the bladder is completely emptied.

In France, where the republic wants to increase the population and the culture values sexuality, women may take vaginal rejuvenation classes or rducation prinal: 10 to 20 sessions of pelvic floor physiotherapy, paid for by the government. Here in the US, I learned about my condition 10 years after I first had symptoms.

A few weeks later, I was at my kids public school fundraiser, drinking and rage-telling the story of discovering the word rectocele. A woman I barely knew joined us, whisper-crying, Stage four tearing. Ill never be the same. Women are suffering in silence, hurt and embarrassed. Shamed again.

The New York Times has devoted an admirable amount of editorial space to the women in Africa who suffer from fistulas, their dignity and daily routines compromised by bodies that leak urine or feces because of childbirth or assault.

What no one is talking about not medical professionals, not educators, not mothers, not their partners are the various states of post-partum prolapse that plague women after childbirth, causing a similar loss of control and dignity to that faced by fistula sufferers. The emotional and sexual ramifications of my situation included secrecy, shame and isolation.

We need to make the words rectocele and cystocele and urethrocele and enterocele, each a type of pelvic organ prolapse resulting most often from childbirth and ageing, part of the common vernacular of womens health. The words are utterly absent, even to those of us who seek to learn more about these conditions and educate others.

According to the Mayo Clinic, prolapse means to slip or fall out of place. A rectocele is when the rectum bulges into the vagina. A cystocele is when the bladder bulges into the vagina. A urethrocele is when the urethra bulges into the vagina. An enterocele is when the small intestine bulges into the vagina. So basically, they are vag bulges.

The American Society for Colon and Rectal Surgeries estimates that 40% of women have a rectocele, yet most people dont know the word. This needs to change. Harvard says that anywhere from 80% to 20% of women might have small rectoceles. Meanwhile, pharmaceutical companies spend and make millions of dollars to keep dicks in the air.

The medical industry is pushing vaginoplasty, labiaplasty, and Viagra for women, to keep women young and tight and looking like porn actors. I know our culture doesnt make much room for older women, let alone our vaginas, but shouldnt we be spending some of this time and money to care for the post-maternal vagina?

And I dont mean surgery with the vaginal mesh that was recently banned in New Zealand. We need sexual education and respect for mothers vaginas vaginas that have been through a lot. We need to be talking about prolapse and non-surgical treatments like diet, hydration, biofeedback, electrical stimulation, and core strengthening exercises.

To be sure, some vaginas take a licking and keep on ticking. I have many friends who didnt tear, who gave birth and kegeled their way to safe and healthy sexual lives.

My vagina has changed a lot in my 46 years. I loved exploring it for pleasure as a child. Then my vagina was injured when I was raped at 15 and didnt tell. Later I had a lot of great sex and a lot of mediocre sex. I birthed two children through this space, a space that still holds potential for experience and love.

There is no equality without reproductive rights, there are no reproductive rights without knowledge of the female body, and there is no knowledge of the female body without acknowledgment of the post-maternal vagina. The lack of education and attention to my and thousands of mothers pelvic injuries is another sign of our countrys indifference to womens rights and health.

We are, as a nation, in fits and starts, beginning to do better for womens lives. I am thrilled, for example, to see longstanding silences broken. I am happy to see menstrual equity with states moving toward tax exemption for tampons and other feminine hygiene products.

So, how about we ask the medical and pharmaceutical communities to do better by mothers bodies by acknowledging and treating the physical injuries caused by giving birth. By acknowledging our bodies as they are. By talking about maternal sexuality. By granting us language and autonomy. We can start conversations and healing.

And, how about we ask the mothers in our lives how their vaginas are doing? Hopefully, with the proper education, their answers wont surprise us.

Read more: https://www.theguardian.com/us-news/commentisfree/2017/dec/28/vaginal-health-post-partum-maternity-rectocele

The sound of mega orgasms: the female composers taking music into intimate places

A soundtrack to an erotic feminist film, the crunch of crisps in your own mouth, a composition for strap-on and electric guitar meet the women who are making music and telling stories on their own terms

In the early 1990s, the accordionist and musical improviser Pauline Oliveros wrote the soundtrack for a feminist porn film called The Sluts and Goddesses Video Workshop. The film is presented and co-directed by Annie Sprinkle, a sex worker turned academic whose lecture covers everything from deep breathing and vaginal bling to STD prevention and mega orgasms. Along the way, we get a spectacular sonic counterpart of drones, glitches, bleeps, twangs and pulsations.

Conventional porn music this is not: no sultry saxophones, no oily bass guitars. Instead, Oliveros made sounds that are fun, tactile and inquisitive. If Sprinkles mission was to confront industry standards of what erotic looks like, freeing viewers to define their own tastes, Oliveros reminded us that the power to decide what music means should ultimately belong to the listener.

This autumn, in the wake of the allegations against Harvey Weinstein and others, a couple of things became urgently clear. We must listen more carefully to womens voices, and we must change the power structures that govern much of public and private life, including the arts.

A
A screengrab from The Sluts and Goddesses Video Workshop (1992) by Annie Sprinkle and Maria Beatty Photograph: Vimeo

Pauline was empowering her listeners, says the writer Ione, the late Oliveross partner and regular collaborator. Sluts and Goddesses was not pornography, not if you mean the word in any pejorative or sleazy sense. It was about sexual freedom, showing that sexuality is a natural and wonderful thing for women. The sounds Pauline made were deeply sensual because they related to the body. Her music was always about the Earth, the body, being human, the cosmos.

The film gets a rare public screening this week at the London contemporary music festival, in a section termed (brace yourself) New Intimacy. Contemporary music has a long and tetchy history of labels, schools and isms, almost all coined by programmers or academics rather than artists themselves. New Intimacy seems a cheeky throwback to the contentiously named New Complexity and New Simplicity movements of the 1980s.

Empowering
Empowering listeners Pauline Oliveros. Photograph: Vinciane Verguethen

There is a particular irony to the new bit, given several of the works at LCMF are three or four decades old. But what about the intimacy? Modernism was about removing the body from art, says festival director Igor Toronyi-Lalic. About removing personal identity and prioritising science, abstraction and objectivity. With postmodernism, the body is reinserted into feminist art, queer theory. That is whats at the heart of the New Intimacy movement.

The series includes a work by Kajsa Magnarsson for strap-on and electric guitar; a piece by Claudia Molitor to be performed by audience members within their own mouths as they chew sweets, popcorn and crisps; and the 1965 film Fuses, in which Carolee Schneemann documents the most intimate moments of her relationship with composer James Tenney. Also in the mix is the pristine and ultra-sparse Second String Quartet by Wandelweiser composer Jrg Frey music so stripped back and delicate it can start to feel febrile, like the tender stuff left exposed after some kind of sonic disrobing. Aesthetically, its probably the diametric opposite to the sparkly dildos and nipple tassels of the film, but maybe the point is how these works share a potential to empower and turn the attention back on audiences.

Claudia Molitor has been exploring the haptic in music for nearly two decades, and welcomes the wide scope of New Intimacy. Its a provocation, right? Most of the time, women arent supposed to express ourselves in certain ways because its considered unbecoming, so maybe its good to put something out there that is unbecoming. If it makes people uncomfortable, thats all right. A lot of women spend quite a lot of their lives feeling uncomfortable. Anyway, its hardly new. Mozart said it with Cosi Fan Tutte: women have the same desires as men.

Eva-Maria
Eva-Maria Westbroek in the opera Anna Nicole by Mark-Anthony Turnage in 2014. Photograph: Tristram Kenton for the Guardian

Composer and performance artist Jennifer Walshe likewise uses her work to deal with gender and identity. Her confrontational 2003 music theatre piece, XXX Live Nude Girls, featured Barbie dolls in all manner of sexual positions and scenarios of abuse. If you want to privilege the female gaze, she says, you have to privilege it at every level of production, right down to technical crews. Think of an opera like Anna Nicole. This was a work by Mark-Anthony Turnage, about the Playboy star Anna Nicole Smith. The librettist is a man, the composer is a man, the director was a man. Why arent women allowed to write their own stories?

Walshe also questions the potential in New Intimacy for exploitation or plain voyeurism. Sometimes I feel that women are forced into a position where they are only permitted to have a voice by articulating their most intimate details, she says. Memoirs by musicians like Viv Albertine, Kim Gordon, Carrie Brownstein, Kristin Hersh all of which are books I love get very deep into the personal in a way many memoirs by male musicians dont.

Is there the expectation that in telling their stories, they have to get into these details? That their stories are only worth being heard if they are explicit? Or, as women, is part of dealing with life being forced to deal with gender or sexuality in a way many of their male collaborators dont have to, which means its only natural to talk about it?

One lesson from Weinstein is that his alleged victims didnt speak out because the industry granted him a power that robbed them of their agency. We need to trust ourselves, wrote Mona Chalabi in the Guardian. The sickening allegations have reminded me just how important it is that we trust our instincts.

This also applies to the danger of glorifying artists. For centuries, we built up personality cults around composers made gods out of men like Mozart, Beethoven, Wagner, Britten and Stockhausen. These genius narratives might have let us believe we were accessing the divine when listening to Tristan und Isolde or Mittwoch aus Licht and so feel somehow aggrandised by proxy but if composers were supposed to be superhumanly talented, their means of production remained unattainable to the rest of us, and their behaviour potentially unaccountable. It was a recipe for alienation, for too much licence, for abuse.

Red
Red Note Ensemble perform 13 Vices by Jennifer Walshe and Brian Irvine at the New Music Biennial in Hull. Photograph: James Mulkeen

Pauline was very much not into all that, Ione says. All that genius crap. Just look at the collaborative, collegial, supportive way she worked with Annie and the group of women who made Sluts and Goddesses. Look at the way she improvised with anybody.

It seems contemporary music is moving increasingly in that direction. Gone are the towering iconoclasts of the 20th century. Instead, programmers from Huddersfield contemporary music festival to Glasgows Counterflows to LCMF are looking to provide nimbler, more personal experiences.

Its about getting us to relate to ourselves better, says Molitor, whose piece 10 Mouth Installationsincludes an instruction sheet suggesting the best order in which to eat the sweets, popcorn and crisps (Hula-Hoops to be precise). Its about not going for a big public statement where one person declares something and the audience laps it up. Its more of a negotiation: Im an individual, youre an individual, so lets all acknowledge our bodies and our presences in this space.

If contemporary classical music seemed a branch of the avant-garde too erudite for everyday gender politics, too esoteric to deal with the erotic, think again. With its flexible forms, exploratory sound worlds and playful intellectual provocations, this music is proving to have a special potential to redress the way we relate to status, to each other, to ourselves not only for those making music, but also for those listening.

Read more: https://www.theguardian.com/music/2017/dec/06/sound-of-mega-orgasms-female-composers-london-contemporary-music-festival-new-intimacy

The ‘vampire breast lift’: just another grotesque beauty boob | Van Badham

A procedure that draws blood from a womans arm and extracts the platelets to pump into her breasts has doubled in popularity

Through conquest, Alexander the Great established one of the most vast land empires of the classical age. It stretched from the Mediterranean, through North Africa and on to Asia. He was undefeated in battle, awash with the trophies of victories, self-anointed as a god. Yet a popular quote describes the young conquerer-king viewing the magnificence of his achievements with despair: And when Alexander saw the breadth of his domain, he wept for there were no more worlds to conquer. Most people know these words from when Alan Rickman says them in Die Hard.

Its a shame that Alexanders lifespan pre-dated the modern beauty industry. Because if you desire territorial conquest opportunities that are limitless, you dont need to bother with the satrapies of Asia Minor, the kings of Persia or a shoeless Bruce Willis anymore. Just grab the nearest female body and slash, slice, stab, burn and pillage away. No phalanxes of Macedonian foot-soldiers are necessary merely gather an Instagram account, a willing celebrity endorsement and the kind of prevailing external culture of misogyny that wont let any human female rest her own self-hatred for a single minute. Actually, you dont even need the celebrity or the Instagram account. Just the last one although it never hurts to shove a freebie into the Oscars showbag.

My assessment is based on how last years Oscar treat is todays latest abomination masquerading as self-improvement. Its a breast plumping procedure adapted from the equally grotesque vampire facial innovation of some years back. You may remember Kim Kardashians blood-smeared face promoting it in 2014 as if summoned to do so by human sacrifice and Satanic ritual.

This week News.com.au reports that the popularity of vampire breast lifts has doubled in the past year. Over the course of two 60-minute sessions, the plot of every body horror movie in existence is spun together for the procedure: blood is drawn from the patient/victims arm, then whorled through a centrifuge then platelet-rich plasma is sucked from the blood, which is pumped into human boobs, with needles.

You dont go up a cup size, regain lost years of youth or achieve dominion over the ancient subcontinent, but apparently it gives the cleavage a fuller look.

Full disclosure: I watch a lot of genre movies and whenever a woman shares a context with blood and centrifuges, nothing good happens next. Human females are actually being encouraged to pay about $2000 for an experience that rationally one would hire a therapist or many to forget.

Dr Herbert Hooi, the man owning the dubious honour of being the one of the worlds pioneer cleavage-enhancing breast-embloodeners, advocates the procedure for those seeking shapelier breasts, which is a thoroughly objective, scientific criteria for wilful bodily trauma if ever there was one. It seems an appropriate punishment for women who have dared to saggen their breasts with the self-indulgence of nursing children or growing older to oblige them into redness, swelling and possible bruising after getting their tits re-pumped with fresh blood.

Dr Hooi says his vampire boob-needles are not for everyone, so, please, be assured that makes everything OK. Tattooing a penis on your face is not for everyone but people do that, too. Ramming your face full of nails to more resemble the bubbly side of a pancake can also be niche activity, kind of like more of a hobby than anything else, pfft, whatever, live and let live, people can do what they want, there are no broader social implications, Yolo.

Yes, of course some women choose to do these things to themselves. But how rarified and elusive has the standard for the optics of female humanity become that mere shapelierness of boobs is now in competitive play? Ive listed the non-invasive procedures advertised to women before. How is it now possible the radical arc of breast enhancements, liposuction, chemical peels, eyelifts, browlifts, backlifts, grin lifts, butt implants, jawline advancements, bellybutton inversions, eyelash transplants, areola reductions, vaginal canal tightening and hacking off ones labia is still not enough?

An industry-wide business model understands that as long as female beauty has greater cultural value than female achievement, it doesnt matter how gruesome, barbaric, cruel or painful the new treatment to improve beauty may be. It doesnt matter to which part of the body its targeted or what it does. You just need to convince a viable market share of women that theyll be deficient without it, and as a sense of deficiency is admitted and shared among women, it will spread like aesthetic contagion. The size of your empire surely will double in a year.

The quote about Alexander the Great that they use in Die Hardis actually bastardised from dramatist William Congreve. The context of it is relevant: Having only that one hope, the accomplishment of it must put an end to all my hopes; and what a wretch is he who must survive his hopes!

It doesnt seem much blessing for women pursuing what society deems most to be beautiful that this particular wretchedness is one theyre unlikely, ever, to know.

  • Van Badham is a Guardian Australia columnist

Read more: https://www.theguardian.com/commentisfree/2017/oct/10/the-vampire-breast-lift-just-another-grotesque-beauty-boob

‘A third of people get major surgery to be born’: why are C-sections routine in the US?

Caesareans have transformed from life-saving intervention into risky procedure performed for one in three births and often geography is the deciding factor

Carmen Walker didnt realize how bad things had gotten until she heard her doctors voice from across the operating room: Im going to try to save her uterus.

Walker had delivered her first child by caesarean section, so when she became pregnant a second time, doctors didnt think twice before scheduling another. And then another and another. Now, giving birth to her sixth child, she was experiencing the consequences: placenta accreta, a condition which is linked to multiple C-sections and can result in fatal bleeding.

Caesarean sections have saved the lives of millions of infants who might have otherwise been killed or permanently injured during difficult births. But in the US, the rate of caesareans has increased so much over the decades that the surgery has been transformed from a life-saving intervention into a procedure performed as a matter of course during one in three US births.

In 2015, the latest year for which the Centers for Disease Control has data, the share of births by C-section was 32%. The World Health Organization has suggested that the rate should not be higher than 10% – 15%, while other experts have suggested it should not be higher than 19%. The last time the USs rate was that low was during the 1970s.

Carmen
Carmen Walker and her sixth child, Olivia. Photograph: Carmen Walker

We are quite worried when the C-section rate goes above 30%, as it is in the United States, said Dr Flavia Bustreo, the assistant director general for family, womens and childrens health at the World Health Organization. It becomes routine but it is still a major surgery. That carries a long-term effect on maternal health.

A C-section rate of 10% to 15% is natural, she said. Above 15%, you dont have additional benefits, and you have the risks, and you have the unnecessary health costs.

A third of people get major surgery to be born, said Dr Neel Shah, a practicing OB-GYN and an assistant professor at the Harvard School of Medicine who works on ways to reduce avoidable C-sections. Many of the mothers in that equation were having a low-risk birth, he added that is, there were few or no medical indications that a C-section was necessary.

That is hundreds of thousands of women every year who get surgery they never need in the first place. Thats crazy. We can do much better than that.

The caesarean rate in the US has shot up by roughly 50% since the 1990s

The associated risks are serious. For the mother, they carry the potential for deadly bleeding, a lengthy recovery, organ damage and permanent injury. Compared with women having a vaginal birth, those having a C-section for the first time have 3.1 times greater risk of blood transfusions, a 5.7 times greater risk of an unplanned hysterectomy and a six times greater risk of being admitted into intensive care.

The rate of C-sections is now well beyond what is medically justifiable to save the lives of infants, experts say.

As C-section rates in the US have gone up, there has been no accompanying rise in infant survival rates. In the case of low-risk mothers, theres not a lot of evidence of improved outcomes, said Eugene Declercq, a professor at the Boston University School of Health who studies caesareans. Its just not there.

Women having a first-time caesarean in the US face a greater risk of dangerous pregnancy complications than women giving birth vaginally

In fact, some experts believe this rise in caesareans is one of the many intertwining factors contributing to crisis rates of maternal mortality, or death, and morbidity defined as significant injury related to a pregnancy.

Its certainly one of the downstream consequences of performing avoidable C-sections, said Jill Arnold, who runs a website that tracks individual hospitals C-section rates, and works as a consultant to Consumer Reports. Its connected to seeing more women bleed out, or have near misses.

Placenta accreta, for example, the condition that nearly killed Walker, is roughly 600 times more common today than it was in the 1950s, an increase scientists have linked to the rise in C-sections.

A 2007 analysis of more than two million birth outcomes in Canada found that women with low-risk pregnancies were three times more likely to die or be seriously injured if they had a C-section rather than a vaginal delivery. The findings helped move the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine to put out a joint call in 2014 for reducing avoidable C-sections.

For most pregnancies, which are low-risk, caesarean delivery appears to pose greater risk of maternal morbidity and mortality than vaginal delivery, the groups said.

In the US, the rate of maternal deaths per 100,000 live births is 26.4, and it has been rising since 2000. Just about every other western country has seen a decline in maternal death rates since 2000, and the next closest western country, the UK, has a mortality rate of 9.2 per 100,000 live births.

It is very, very clear to me the connection between the number of C-sections and mortality and morbidity, said Dr Shah.

Whats not so clear is whether c-sections are whats causing maternal mortality rates in the US to rise. Declercq, who notes he is no fan of unnecessary C-sections, says the bigger drivers of maternal mortality probably include factors like the opioid crisis and the fact that many new mothers are dropped fromMedicaid, the government-run health program, shortly after they give birth.

Just addressing the C-section rate alone wont reduce the maternal mortality rate. Other developed countries have C-section rates that are as high as the United States. A 2012 international comparison found that the C-section rate was 21.8% in Norway and 24.4% in the UK but 31.7% in Germany and 26.2% in Canada.

But those countries also have medical teams that are better at recognizing and treating life-threatening pregnancy complications, investigations have found, and experts note they do not face factors like poor access to maternity care.

Why is the C-section rate rising?

The factors that drove up the rates of C-sections are numerous and difficult to untangle. Women who are older, heavier or have certain health conditions can be more likely to need a C-section to deliver a healthy baby.

But changes in the US population dont completely explain the increase seen since the 1970s. One factor is that doctors recommend C-sections when they believe the fetus is showing signs of distress, but many hospitals have a culture or use technologies that send a physicians better-safe-than-sorry instincts into overdrive.

Fetal heart monitoring strips, which produce a steady stream of information about a fetuss vital signs, are a prime example, said Declercq, because they furnish physicians with a torrent of information including, inevitably, false positives to scrutinize for signs of trouble. The rise in C-sections since the early 1970s closely tracks the introduction and widespread adoption of fetal heart monitors.

Then theres the fact that C-sections dont look like a public health disaster to those up close and personal with them.

I didnt realize this was a problem until you zoom way out, said Dr Shah. Theyre so common they look fine. And people are usually fine. They had their babies and they love their babies. Even people who had a stressful birth experience tend to look back fondly.

Many doctors and hospitals are in the dark about the rate at which they perform C-sections for low-risk births, because none of the government agencies or accreditors who oversee hospitals require the figures to be public. Arnold said she once heard of a hospital CEO crying the first time she learned her hospitals figures.

Pilot programs have found that, just as in Arkansas, the simple act of disclosing the numbers can cause hospitals to reduce their rates.

Many hospitals have a long way to go. Healthy People 2020, a federal initiative to improve US health outcomes and Leapfrog, a nonprofit that lobbies hospitals to release various health metrics as a way to improve overall care, deems a hospital to meet acceptable standards if C-sections account for no more than 23.9% of births.

In 2016, 55% of hospitals who voluntarily reported data to Leapfrog had a C-section rate that was higher than 23.9%, or 730 hospitals out of more than 1,300. At 223, or nearly 17%, more than one in three births takes place via C-section.

Honestly, it should be lower, Arnold said, referring to the 23.9% threshold. Even hospitals with high-risk patients, every hospital should be able to hit that number.

C-section rates by hospital

Geographical disparities

And yet, in the US, a womans odds of undergoing this risky operation are completely untethered from whether or not her circumstances require it.

A womans greatest risk factor for having a C-section is what hospital she chooses. Looking at a map, its normal for one hospital to have double the caesarean rate of a neighboring hospital located less than a mile away and serving the same community. Other times, geography equals destiny. The south in particular contains whole communities served only by hospitals where the caesarean rate is 33% or greater.

Walkers story illustrates the point. Her first caesarean was necessary, she says. She was in labor for 36 hours, but she never dilated enough to deliver vaginally.

But by the time she was pregnant with her second child, she lived in Mississippi, a state that had a C-section rate of 36.8% in 2014 and where scarcely any OB-GYNs are willing to attempt a vaginal delivery after a woman has already had a C-section. Her lack of options, she says, locked her into a succession of increasingly risky operations.

Walker wound up lucky. Although she spent three days on high-risk watch in the hospital and would still be undergoing a painful recovery months later, her doctor stopped the hemorrhage. The blood loss meant she remembers little about the initial aftermath, but she remembers being unable to stand up under her own power.

Her complications could have been far more severe. Placenta accreta patients account for 38% of caesarean-related hysterectomies, and up to 7% of women with placenta accreta die.

Read more: https://www.theguardian.com/lifeandstyle/2017/oct/04/one-in-three-us-births-happen-by-c-section-caesarean-births

Revealed: Johnson & Johnson’s ‘irresponsible’ actions over vaginal mesh implant

Woman awarded record $57m damages over implant launched with no clinical trial and marketed despite higher failure rate

A vaginal mesh implant made by Johnson & Johnson (J&J) was launched without a clinical trial, and then marketed for five years after the company learned that it had a higher failure rate than their two earlier devices.

Internal company emails disclosed in a US court case, in which a 51-year-old woman was awarded a record $57m in damages this month, also show that senior executives even briefly considered suppressing unfavourable data that could compromise the future of the device.

J&Js Ethicon unit was found by a US court to be liable for the serious injuries Ella Ebaugh suffered after receiving a mesh implant to treat urinary incontinence. The mother of five said she was left with a mangled urethra, bladder spasms and continual pelvic pain after an unsuccessful procedure that led to three revision surgeries to remove mesh that had cut into her urethra and migrated to her bladder.

But documents submitted to the court show J&J staff had raised concerns about the spinning of data in emails and male executives are seen bantering about a suggestion that sex with an earlier patient with mesh complications must be like screwing a wire brush.

Ella
Ella Ebaugh, who was awarded $57m after a court ruled that Johnson & Johnsons Ethicon unit were liable for the serious injuries she suffered. Photograph: CBS

When it emerged from initial data that the success rates for a new device looked to be way below those seen for previous products, Ethicons director of sales, Xavier Buchon, suggested in an email stop[ping] for a while such publications that could compromise the future.

The J&J implant, used to treat urinary incontinence, was launched in 2006. Despite the early indications of a high failure rate, it was only withdrawn in 2012 after being used in thousands of operations in the US, the UK and Australia. The documents raise uncomfortable questions for the manufacturers of vaginal mesh products, which are the subject of growing controversy.

The implants, which reinforce tissue around the urethra, are widely used to treat incontinence, and for the majority of women the procedure is quick and successful. However, some women have suffered debilitating complications, including severe pelvic pain, the mesh eroding through the vaginal wall or perforating organs.

Class action law suits are underway in Australia and the US, where lawyers claim that patients have been exposed to unacceptable risks; in England, NHS data suggests as many as one in fifteen women later requires full or partial removal of the implant.

Vaginal mesh implant

Ebaugh, whose case was heard in Philadelphia, said that her complications have left her with constant pelvic pain, meaning for example, that although she attended her daughters recent wedding, she was unable to enjoy it. I feel like Im on fire down there, she said in an interview with CBS.

The tranche of documents, revealed during the trial, places a spotlight on tensions between Ethicons commercial and clinical divisions at the time it launched its miniature mesh product, called the TVT-Secur, in 2006.

The company hoped that the new device, which was smaller and required fewer incisions, would reduce complications seen with its earlier devices. But getting to market ahead competitors, who had similar offerings in the pipeline, was described as priceless in company documents. It was approved for use without a trial under US and European equivalence rules, which allow this when a new device is similar to existing ones.

Carl Heneghan, professor of evidence-based medicine at the University of Oxford who has called for a public inquiry into the use of mesh, condemned the decision to launch a device before a trial, saying this had led to direct patient harms. It has made it impossible to provide informed choice to women, and points to a regulatory system that is failing patients, he added.

Prof Bernard Jacquetin, an eminent French gynaecologist whose early study on TVT-Secur had led to misgivings among J&J management, told the Guardian the company had acted irresponsibly by launching the device without adaquate evidence.

Ahead of the devices original launch, Jacquetin was invited to the US to give advice on the new design, but was taken aback when he was presented with a boxed-up product ready for release. Jacquetin and colleagues later carried out a study in 40 patients, which found success rates of 77% two months after surgery, compared to the roughly 85-90% success rate commonly reported for Ethicons original TVT mesh device.

On learning that Jacquetins results did not look promising (though not referring to the eventual 77% figure), marketing manager, Fabrice Degeneve emailed his superiors to ask: How should we handle this without compromising the use of this new technique?

Ethicons director of sales, Xavier Buchon, replied: This is for sure a big concern, before suggesting withholding results while the company reviewed the patients to be included in the analysis. No way to hide the truth but to make sure it has been done correctly in terms of procedure and inclusion, he added.

In the event, the findings were presented at a major international conference and Jacquetin said he never felt pressure to bury unfavourable results. But he adds: I was really disappointed. I told many people at Ethicon it was not [a good device].

In 2012, TVT-Secur was withdrawn from the market, along with three other mesh products. J&J declined to provide exact figures on how many women had received the implants.

In other emails, J&J staff complain of colleagues constantly spinning data and of a dangerous blurring of the lines between commercial and research divisions. I am continually amazed and surprised at our need to push back, wrote Judi Gauld, Ethicons former clinical director in Scotland.

Other emails show a blas attitude to distressing complications. In one, dated from 2003, a surgeon sought advice on treating a patient with a 2cm stretch of mesh poking through her vaginal wall. Sex is like screwing a wire brush according to her spouse, the doctor wrote. Martin Weisberg, Ethicons medical director, replied: Ive never tried the wire brush thing so I wont comment.

Following the trial, Ebaughs lawyer, Kila Baldwin, said in a statement: I am pleased the jury recognised the recklessness of J&J and I hope the company takes notice of the verdict and adjusts its practices accordingly.

Johnson & Johnson said they plan to appeal the verdict. In a statement, the company said: We believe the evidence in the Ebaugh trial showed Ethicons TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiffs continuing medical problems.

Over two and a half million documents have been provided to plaintiff attorneys by Ethicon as part of the pelvic mesh litigation in the United States, and selective disclosure of certain sentences or documents without proper context can be extremely misleading.

Read more: https://www.theguardian.com/society/2017/sep/29/revealed-johnson-johnsons-irresponsible-actions-over-vaginal-mesh-implant

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