Why you should care
Because you need to know what questions to ask before going under the knife.
The Netflix documentary The Bleeding Edge shows how when the medical device industry rushes to innovate, patients often pay a devastating price.
Medical technology is often viewed in a favorable light. It’s man’s triumph over nature, the eradication of disease, the prolonging of life. But between an idea’s inception and execution, there are pharmaceutical manufacturers and eager sales reps who awaken each morning to the siren song of quarterly bonuses. And in the $400 billion medical device industry, the music is contagious.
The result is a Wild West of industry that finds ways to short-circuit clinical trials and circumvent Food and Drug Administration regulations, sometimes staying just right of the law and sometimes not. Either way, human experimentation has become business as usual. We hear from three individuals who were promised the hope of “life-saving technologies” but instead were dealt a devastating blow.
A Breakthrough Contraception That Could Be Making Women Sick
In 2013, Christine C. was 39 years old and had a full house with four kids. Enough kids, she and her husband agreed. They decided it was time for a permanent form of birth control. A vasectomy was their first choice, but it wasn’t covered by insurance. So Christine’s doctor told her about another option: Essure. Essure is a coiled metal device that gets implanted in each fallopian tube to make conception almost impossible. It would be quick. It would be painless. And — perhaps best of all — it would be covered by insurance. Christine decided to go for it.
But the implantation was anything but painless. “Even with all the medication they gave me, the pain was so bad I literally lifted myself up off the table,” said Christine. The doctor told her it would be OK, that it was almost over, but she said she had debilitating pain the rest of the day. And when her next period began, it did not stop for six months.
I should have been told what Essure was actually made of and how those different ingredients could affect the body.
By the time her period agreed to a cease-fire, Christine said she had developed severe joint pain and daily headaches. When her period returned, it brought with it unbearable cramps and a flow so heavy she could not leave the house. “It felt like a new symptom was coming on every day. One night I was lying in bed, and it hit me: I never had any of these problems before Essure.”
Taking matters into her own hands, Christine learned everything she could about the metal devices implanted in her, and how between the coils was something called polyethylene terephthalate, better known as PET fibers. “It’s a type of plastic that’s known to cause inflammation in the body. That’s why they put it on there. The inflammation causes scarring, and that’s what causes you to become infertile,” Christine said. “But nothing is stopping that from inducing inflammation in the rest of the body,” a point that’s been corroborated by some doctors.
Christine received a routine HSG — an X-ray of the uterus and the fallopian tubes required for Essure recipients — and it revealed that one of the devices had migrated from her fallopian tube to her abdomen. Not only was it free to puncture another organ, but it was unable to do its one job: prevent pregnancy.
She finally decided the implants had to go. But upon her request, her doctor could not take them out because there was no removal protocol. Christine heard the same answer from every OB/GYN she contacted. Finally, one office referred her to a gynecologic oncologist. And this doctor would do it.
Removing Essure meant having a hysterectomy, as a new HSG revealed both of Christine’s Essure implants had migrated and punctured her uterus. It was major surgery, but she felt better immediately. “I woke up from anesthesia and told my husband, ‘It is so weird my body doesn’t hurt,’” she said. “All the joint pain was gone. I stopped having constant headaches.”
Unfortunately, this surgery didn’t end all of Christine’s problems. She now has to take medication to control hypertension and an elevated heart rate — two conditions that she hadn’t been diagnosed with prior to the Essure implants. She also has prolapse issues from her hysterectomy, which eventually will require another surgery. In a 2018 release, the FDA stated that it had received 12,000 reports last year about problems with Essure, 90 percent of which involved attempts to remove the device. There’s even a Facebook group called Essure Problems, where its 30,000-plus members post about negative side effects, including bleeding, fatigue, hair loss and tooth decay, most of which they attribute to allergic or autoimmune reactions to materials in the device. *Bayer, the parent company of Essure, just announced in July 2018 that it plans to stop selling the controversial birth control device in the U.S.
Looking back, Christine said more information should’ve been provided during her consultation. “I should have been told what Essure was actually made of and how those different ingredients could affect the body,” she said. “If I had known there were PET fibers in Essure, I would have never gotten it.”
The Case of the Exploding Breast Implants
Over the course of nine years, more than 400,000 people received silicone breast implants from the now-bankrupt French manufacturer Poly Implant Prothèse, or PIP for short. PIP — which was pre-emptively liquidated in 2010 — was trying to cut costs by illegally replacing medical-grade silicone with industrial-grade silicone, resulting in defective implants that are twice as likely to rupture compared to other implants. More than 40,000 of these PIP patients live in the U.K., and London-based Jan Spivey is one of them.
Spivey was diagnosed with breast cancer in 2002. She was told both her diagnosis and her treatment plan in one appointment: lumpectomy/mastectomy followed by reconstruction. Her breast implant brand was never mentioned, and she never asked. “I didn’t realize I had a choice,” she said. “I thought, ‘I’m dealing with a potentially fatal disease. I’ll do what the surgeon says.’”
Breast reconstruction can be a painful, multisurgery process, so it took a year for Spivey to distinguish normal symptoms from abnormal. It was then that she finally told doctors about the pain in her left arm, the numbness in her fingers, the headaches and the night sweats. But all this did was send doctors on a scavenger hunt for more cancer. “If I had serious headaches, they’d send me along for a brain scan,” Spivey said. “Then I’d be on high alert, waiting to hear my cancer metastasized.”
By 2012, Spivey was seeing a pain management specialist when news of the PIP scandal broke. “As soon as I heard, I knew I had PIP implants. In my heart, having suffered for as long as I had with this just hideous range of symptoms, I knew it.” Two months later, her doctor confirmed her suspicions: She had PIP implants.
It is probably the biggest regret of my life.
Later that year, Spivey’s implants were removed. However, what was not removed were the capsules her body had created around the original implants. These capsules, mostly made up of scar tissue, are the body’s way of healing around an implant or any foreign object. Upon removal of the implants, Spivey’s symptoms actually worsened. Fatty lumps appeared on her body. She developed joint pain, chest pain and a rash that looked like an allergic reaction. She couldn’t eat. She couldn’t sleep. She lost weight. She was diagnosed with inflammatory rheumatological arthritis. She was treated for an autoimmune disorder. A lot of signs, she was told, pointed to connective tissue disease.
What doctors discovered was that the capsules had been contaminated by the original implants, one of which was missing an antibleed barrier. When the implants were finally removed, Spivey suffered from internal bleeding that had to be stopped with an emergency surgery and four blood transfusions. Four days later, she was diagnosed with a pulmonary embolism. The treatment? Another surgery, and blood thinners that damaged her lungs and created circulatory problems in her legs.
“Turns out, the reason I was bleeding so much is because I have the precancer MGUS,” she said. MGUS (monoclonal gammopathy of unknown significance) is a condition in which someone makes an abnormal protein, called a paraprotein or M-protein, which is found in the urine or blood. While not cancerous itself, MGUS can lead to biALCL — a rare form bone cancer. Both MGUS and biALCL have been linked to breast implants.
While Spivey would rather talk about helping others and advancing research through the PIP Action Campaign she founded, she has one thing to say when she looks back at her decision to have reconstructive surgery. “It is probably the biggest regret of my life.”
The Bone Fracture Glue That Was a Death Sentence
When 58-year-old Joan Bryant checked into the University of Washington Harborview Medical Center in late June 2009, she described herself on a hospital questionnaire as “full of life,” “calm and peaceful” and “happy all the time.” She was there for spinal surgery, hoping to remedy back pain that had dogged her since a 1990 car accident. Less than a month later, Bryant was dead. She passed away from cardiovascular collapse on the operating table after Norian XR, a bone cement, was injected into her spine.
According to news reports, Bryant’s procedure on July 6 was actually the second surgical attempt by Dr. Jens Chapman, who had to stop Bryant’s surgery back on June 29 when she began hemorrhaging. Both surgeries occurred weeks after a grand jury in Philadelphia indicted Synthes Inc., the manufacturer of Norian XR, and four of its executives for conducting clinical trials unapproved by the FDA — a rather sanitized charge that sounds like a bleeped-out version of a song that’s missing all the important lyrics.
It took six and a half years of my life after we figured out we were lied to about why my wife died on the operating table.
Was Chapman aware of the indictment? Impossible to say, and he did not respond to efforts to reach him for comment. But court records show that Chapman was aware of testing Norian XR (formerly called SRS-S) on a pig in a 2002 study funded by Synthes, and the pig died shortly after the cement was injected. And reports state that he was also aware of Reba Golden, a woman who died on his operating table after Norian XR was injected into her spine and the material leaked into her blood stream and caused clotting.
Russell Bryant, Joan’s husband, who sued Synthes, Chapman and the University of Washington, was not interested in retelling his wife’s tragic story. But he did say this: “There was so much collusion and corruption between parties. It took six and a half years of my life after we figured out we were lied to about why my wife died on the operating table. I spent $800,000 cash out of my pocket to pay my legal firm. If I had not spent everything I had available, these guys would’ve walked.”
In 2010, Synthes pleaded guilty to charges and agreed to pay $23.7 million in fines and forfeitures. And the four Synthes executives received jail sentences that ranged from five to nine months. And in 2016, Synthes settled with Bryant’s family as well as Golden’s family, who also sued Chapman and the University of Washington. Chapman continues to practice medicine in Seattle but not at the University of Washington. “One of the agreements I made at the University of Washington was that [Chapman] never be there again,” said Bryant.