Protecting Yourself from the Dangerous Business of Women’s Medical Devices

Thalidomide, DES, the Dalkon Shield, Essure, Pelvic Mesh. The list of medical devices and treatments for women that have gone very wrong is extensive. Learn how big business has put profits over women's safety and health, and my top 5 recommendations for avoiding unnecessary, inappropriate, or possibly unsafe medical treatments. Have a listen to this latest episode of Natural MD Radio, or read the article below.

In 1971, the A.H. Robins pharmaceutical company of Virginia began selling medical devices marketed as the “modern, superior,” “second generation,” and “safe” choice for birth control. It was peddled by a team of hundreds of aggressively trained pharma salesmen to obstetrician/gynecologists, who in turn promoted it to their patients – amongst them our mothers, grandmothers, and great-grandmothers, depending how old you are. I’m old enough to distinctly remember my mother considering whether to get one. She stuck with “The Pill” instead.

Now infamous, the intrauterine device (IUD) known as the Dalkon Shield, distributed to more than 4.5 million women in at least 30 countries (with estimates up to 80 countries), with nearly 2 million of them implanted in women in the U.S, was ultimately responsible for life-threatening Pelvic Inflammatory Disease (PID) and resultant sterility, miscarriages, and death in at least tens of thousands of women in the U.S alone. This was due to its problematic structure and manufacturing materials.

Here’s the thing: Not only did it become apparent within six months of ‘the Shield’ being on the market that this medical device  posed serious health risks – it was found to be remarkably ineffective. The women ‘wearing’ one, as its use was fashionably described, became pregnant at a rate five times that claimed in marketing campaigns, and at a rate much higher than with other IUDs. At least 110,000 pregnancies were documented amongst women wearing “The Shield.” Of these, 66,000 miscarried by the second trimester, and many women suffered septic miscarriages even later in pregnancy. At least 15 are known to have had fatal miscarriages due to infection. There were preterm births reported around the globe, as well as full-term babies born with severe birth defects as a result of the device. Many, if not most, of the women who developed PID became infertile. It’s likely that in the poorer countries in which it was distributed by the United States Agency for International Development (USAID), most women with infection died.

In June 1973, the Centers for Disease Control & Prevention (CDC) found, based on 16,994 physicians who responded to a survey, that 7,900 IUD related hospitalizations had occurred in the first 6 months of that year alone. This ‘safe’ device had not even been put through animal testing prior to its release onto the market. It didn’t have to be. A loophole in the law stated that only after a device had caused injury or death could the FDA, if willing to bear the legal burden, get an injunction to stop sales. Finally, 8 months after its release and use in women, a two-year baboon safety study was begun. Thirty percent of the baboons suffered uterine perforation and one in eight died; these results were never made public. Were this a car responsible for even a fraction of this many deaths, there’d have been an immediate recall. There was no recall. There was no warning. The device continued to be “sold” to doctors as safe, and inserted into women.

In May of 1974 the FDA requested that the company remove the device from the market, but A.H. Robins ‘declined,’ stating that to do so would be to admit culpability and thus lose the growing number of lawsuits being leveled against them. More than 300,000 lawsuits were ultimately filed, and A.H. Robins was legally forced to establish a $615 million reserve fund to cover claims from living victims who were damaged, until the year 2002. Families of those who had died as a result of “The Shield” were not given any compensation, and it’s estimated that if the company were to truly cover victims’ costs of damage until today, for those in the U.S alone, that number would reach into the billions of dollars. The company eventually filed for bankruptcy, but far too long after leaving a legacy of destruction and death in its wake. In 1976, the Medical Device Amendments to the Food, Drug, and Cosmetic Act mandated that the U. S. Food and Drug Administration, finally required testing and approval of medical devices, including IUDs. This chapter in the history of women’s medicine is now considered one of the most catastrophic in modern medical history. The Dalkon Shield continued to be implanted in poorer countries, for example in El Salvador, until into the early 1980s.

Sadly, this wasn’t the first time in modern history that women – including women who would become or were already pregnant – has been exposed to a medical “experiment” gone very wrong.

The Thalidomide and DES Disasters

Thalidomide, thought to be safe and given to pregnant women in the 1950s to treat morning sickness of pregnancy, turned out to be a teratogen – meaning it caused severe birth defects in babies who had been exposed in uterus. Over 10,000 babies worldwide were born with classic ‘thalidomide’ limbs – arms that instead of developing normally look like stunted flippers. These babies also had heart, eye, digestive system, and urinary tract defects, and many were blind and deaf. Only half of these babies survived.

DES (diethylstilbestrol) is another example. This form of synthetic estrogen, first manufactured in a laboratory in 1938, was prescribed in the U.S to prevent miscarriages and preterm births between 1938-1971. An estimated 5-10 million women (and children born of these pregnancies) were exposed. Published research in 1953 showed that DES did not prevent miscarriages or premature births. However, it continued to be prescribed for these reasons until 1971, and was even included in some prenatal vitamins, meaning many more women may have been exposed than is even known. In 1971, a study identified DES as a cause of a rare vaginal cancer in girls and young women who had been exposed to it, including those exposed in utero, and the FDA sent out an advisory, warning physicians not to prescribe it any longer.

DES is now considered a population health tragedy that has and continues to wreak physical havoc and emotional trauma now on at least three generations of women (effects have been found in male offspring as well). Long-term side effects include clear cell carcinoma typically occurring in young women in their teens or 20s, breast cancer, abnormalities of the genital tract that prevent conception or pregnancy, and possible increased risk of cardiovascular disease. As Sybil Shainwald, the pioneering women’s health rights attorney stated, “Countless women have lost their fertility, their reproductive organs, and their lives because pharmaceutical companies have put unsafe, untested…drugs and …devices on the market in pursuit of profit – and women – trusting their doctors – take them without question.” It was exactly this type of medical history that inspired me to be a Midwife and then a Medical Doctor.

The Essure Catastrophe

While it would be nice to just consider these problems ‘ignorance of the past,” they’re not. Let’s take the Essure medical device. Essure was designed to provide permanent contraception – or in medical parlance. A metal coil that is inserted one into each fallopian tube, it works by creating local fibrosis (scarring). This scarring is supposed to block that fallopian tube and thereby prevent an ovum and sperm from meeting. It was described as a less invasive, less expensive alternative to tubal ligation.

The device, which I was taught to insert in my OB/Gyn training, but which I, from day 1, firmly discouraged women from getting, was designed to remain in the tubes for a woman’s lifetime, yet its approval by the FDA was based on only short-term safety studies. Of the 745 women in the premarket studies, 92% were followed up for safety at one year, and 25% at two years. That’s it. Yet initial studies found that about 4% of women experienced complications such as fallopian tubal perforation or misplacement of the device at the time of the procedure, sometimes requiring several devices to be implanted rather than the recommended single device in each tube. So how did a 2009 review concluded that Essure appeared safe and effective based on these short-term preliminary studies?

Well, it turns out if wasn’t so safe. Thousands of women began reporting serious side effects, symptoms, and adverse effects, from moderate chronic pain to severe chronic vaginal bleeding to new onset of autoimmune conditions. A Facebook group called Essure Problems, which by early 2017 had 33,140 members, called the device “E-hell.” Their reports to their doctors were dismissed. However, all wasn’t quiet at the FDA; as early as 2015, the FDA Adverse Events Database had catalogued numerous complications including: hundreds of unintended pregnancies with the device in place (which occurred sometimes with fragments of the device imbedded in the uterus!), intractable pain and heavy persistent bleeding leading to hysterectomies, tubal perforations, and possible device-related deaths.

By now, European authorities had recognized the problem and in 2017 the European Union suspended the commercial license for Essure. Eventually numerous countries banned the device or it was withdrawn from the market due to bad press and potential legal issues. Yet in the U.S we continued to lag behind. In February 2016, the FDA issued a “black box” label to warn the public about the harmful complications associated with the use of this device – but most doctors do not read black box warnings to patients, and how would a woman know to do that? Finally, by April of 2018 the FDA restricted sale and use of Essure 70% decrease in sales. In July 2018 Bayer announced the halt of sales in the U.S. by the end of 2018, and as of now the device is no longer in use.

How many women have had this device implanted? About 750,000. The devastating saga of this device – but also the awesome power of women rising together to self-advocate, is featured in the 2018 Netflix documentary The Bleeding Edge.

Haven’t They Learned By Now? The Problem with Pelvic Mesh

Urogynecologic mesh (also called transvaginal mesh) is used to treat stress incontinence and pelvic organ prolapse, problems which lead to 1 in 5 women to have surgical repair in the lifetimes to reverse symptoms like pelvic pressure, pain during sex, and mild to even debilitating urinary leakage – moderate to severe levels of these conditions affect about 20% of women. The mesh is a net-like ‘hammock’ if you will, held in place by sutures or medical staples, that is used to provide permanent support organs that may have been weakened by stretched ligaments due to childbirth, or hormonal changes that occur with menopause. Like the Essure Device, it was able to bypass the most stringent of FDA testing standards because it was, in essence, grandfathered in based on the fact that mesh was already in common use for other medical purposes, for example, hernia repair. And like the Essure device, high levels of safety and effective outcomes were assured to the women being offered the pelvic organ repair, with mesh. And like the Essure, pharmaceutical companies who make the meshes marketed them heavily to surgeons treating pelvic organ prolapse, usually urogynecologists.

Were adverse events and problems recognized? Well let’s put it this way, the device was in use until earlier this year (2019), yet the FDA had already begun issuing safety warnings about an increased number of adverse event reports related to mesh, to doctors and consumers back in 2011. Then in 2012, the FDA reclassified this as a high-risk medical device.

Were women informed of this risk or the FDA categorization when being offered this surgical repair? Most were definitely not. The level of suffering women report from this device is astonishing. I have heard stories of and from women who now live with chronic pain, vaginal damage and scarring, as well as fistulas, meaning tracks between organs where these shouldn’t be, so for example, between the uterus and the bladder, or vagina and rectum, and who have had numerous ‘repair surgeries’ without improvement, and who have not only lost their ability to have sex because of pain, but who have lost their marriages. The number of women who have suffered from this device is astonishing, and because it, like the Essure, creates scarring that holds it in place, removal of the device can entail hours of difficult surgery, can lead to permanent damage of other nearby organs (bladder, uterus, bowels), nerve damage, and it isn’t always possible to remove all or even most of it. Like with the Essure, tens of thousands of women, including some who are quite young, will live with the ongoing consequences of this device for the rest of their lives.

While there are certainly examples of its lifesaving heroism unfortunately, modern western medicine is replete with examples of treatments, primarily for women, that have been proven unnecessary, harmful, deadly, and sometimes, all three. In fact, western medicine is built on a foundation and history of misogyny that persists today, and women’s bodies remain big business for a number of extremely profitable industries.

Your Body is Your Business

From cesarean sections to treatment for pelvic floor prolapse and urinary incontinence, there is no end to the everyday challenges that are possible in the realm of what happens in women’s bodies – and sometimes, indeed, we do need medical help to get us through that challenge. But far too often, we’re backed into a corner in our decision-making. We’re told the worst case scenario, made to feel even more vulnerable than we probably already do, as a result of medical settings and medical conversations that leave us feeling small and confused at best, bullied at worst, and most medical providers don’t even offer the appropriate less interventive medical alternatives they should know to offer, let alone natural alternatives. Take for example, the problem with hysterectomies. Half of all women over 60 will have a hysterectomy, and many younger women even in their 20s and 30s, usually for benign reasons that can be treated in other, non-surgical ways. Yet 20 percent are considered medically entirely unnecessary, and only 30 percent of women who have been advised to have a hysterectomy are informed of non-surgical alternatives by their doctor.

Further, too often, women’s own reports of their symptoms, and concerns, are ignored. In fact, just this week I received this note:

Dear Dr. Aviva, For the past year and a half I have been feeling poorly. Long story short, I went to four different doctors to find an answer (yes, you know what’s coming), no luck. In the back of my mind was something you shared about how women’s health is treated differently than men’s; we are not given the same consideration. Because my primary was a woman, I expected a different outcome. In the end, I met with both male and female physicians, and none of them took the time to truly listen to me to help me figure out what was wrong. I finally asked for an MRI (got a chuckle in return) and was diagnosed with a brain tumor two days later (about a month ago). I’m scheduled for surgery next week. Had you not expressed the importance of women advocating for ourselves, I would not have had the courage to ask for the MRI. Words cannot express how grateful I am for you sharing your wisdom.

Here are my top 5 recommendations for avoiding unnecessary, inappropriate, or possibly unsafe medical treatments:

  1. Bring an advocate, or at least a tape recorder. This is a great way to help you stay empowered to cover the most important concerns on your agenda, to review what was said later, particularly if feeling anxious or vulnerable made everything being said sound like a white noise machine (though not relaxing!) and it will usually put your provider into best behavior and most thorough mode. While he or she might not like it, it’s your right to have a supportive ‘witness’ there with you.
  2. Keep your clothes on for the part of the medical appointment where you’ll be talking with your doctor or care provider about your concerns – you can change into an examining gown later if needed.
  3. Advocate for yourself – this is the hardest; ask how truly urgently the intervention is needed, or how long you can wait, ask about your doctor’s outcome statistics, ask about any known adverse effects or problems with the procedure, and insist on hearing about any possible temporizing or healing alternatives. Bring a script or note with your concerns written down in order of priority – most of us get anxious at medical appointments, and when we’re being hurried or even bullied that doesn’t usually make us clearer, more articulate, or comfortable communicating our concerns.
  4. Before you consent to any medication, procedure, or device, make sure your consent is fully informed. Read what women are saying in chat groups, and look online for reliable information about risks and side effects. And consider the “Chase Rule of 3” for about 10 years, or stick with the tried and true rather than ‘newest’ approach if it’s known to be safe.
  5. Don’t hesitate to get another opinion; If your care provider is dismissive or insulting, don't hesitate to find another doctor altogether.

I’m so grateful I’m a medical doctor – there are things I have seen, learned, and performed that are breathtaking examples of what modern science has to offer in terms of symptom relief and saving lives. But as with so many things in our culture, more is not necessarily better, and statistically, when it comes to medicine, more proves to be worse more often than not, and it also proves to often be unnecessary. Your body is your business; mine is simply reminding you of the power you have to believe and practice that. And provide you with the reliable, tried and true, science-backed alternatives your MD probably doesn’t know about, and which also aren’t the latest wellness fad. In an upcoming episode, we’ll talk about pelvic floor prolapse, urinary incontinence, and what you can do to prevent – and reverse them – non-surgically, whenever possible.

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Sue Nixon

I'm reading an article in Smithsonian Magazine called Sidelined, which talks about how women scientists have been left out of the history books. One female scientist they highlight is Frances Oldham Kelsey, who was a pharmacologist and physician for the FDA. She was under pressure to approve thalidomide, but refused, citing the fact that safety tests were inadequate. Leave it to a woman to safeguard the health and well being of babies!