Liza Hanks had a clean bill of health when, in 2016 aged just 31, she started saying goodbye to her three young daughters and planning her funeral.
‘I felt like I was burning inside out, I knew I was dying,’ Hanks says, describing the ’16 months of hell’ she endured between getting silicone breast implants and having them removed.
Within a day of her operation, her eyes were purple and her vision became clouded. Her skin started shedding profusely, falling off her face like snowflakes. Her hair was coming out in clumps. Her body was covered in blistering rashes. She plummeted from 140 pounds to 87 and she would tremble as she walked. She was having regular seizures.
Doctors – in her hometown of Idaho Falls and across the country – were baffled. She became a mystery case, marveled at by hundreds of scientists at medical conferences.
After she tested negative for every autoimmune disease, doctors told Hanks their next best theory: that her fiance, a life insurance entrepreneur, might be poisoning her. (He wasn’t).
None suggested the breast implants could be to blame, and when one did, it wasn’t easy to get them out.
Liza Hanks was told she was dying a year after she got breast implants. After they were removed, her shedding skin, hair loss, confusion and burning sensations disappeared. But to this day no officials will recognize the link between breast implants and autoimmune disorders
Before implants, and during: Hanks, pictured (left) in 2006 aged 22 with her first two children before she got breast implants. Her first set were saline, which ripped. After getting new silicone ones in 2015 aged 31, she started to deteriorate, and was told she was dying (right)
TIMELINE: LIZA’S BREAST IMPLANT ORDEAL
2008: First set of implants (saline).
2009: Youngest daughter born premature with birth defects (missing finger tips). Doctors couldn’t identify why, they said it might be because she suffered infections during pregnancy.
Early January 2015: Right implant ripped out of place during a mammogram.
Late January 2015: Second set of implants (‘gummy’ silicone).
April 2016: Breast implants removed.
Hanks is one of thousands of women who say they have developed excruciating symptoms and diseases after getting breast implants – from autoimmune diseases to cancers to inexplicable side effects.
And yet, an upcoming study has found few women are warned of these risks before surgery.
What’s more – as Hanks found out first-hand – women who do suffer side effects often face insurmountable hurdles to get the devices removed because insurance companies do not recognize the connection between implants and autoimmune reactions.
The FDA is still deciding whether it believes in breast implant illness.
FIRST SET OF IMPLANTS: ANXIETY, BIRTH DEFECTS, AND A MAMMOGRAM THAT RIPPED HER IMPLANT OUT OF PLACE
Hanks got her first set of implants – saline implants, silicone shells filled with water – in 2008 after having two children and developing what she describes as a ‘mom bod’.
She’d lost most of the volume in her breasts, and started to blame her figure for issues with her husband of five years, with whom she is still close friends.
‘My love language is kind of physical so I blamed myself for any issues in my marriage,’ Hanks said. ‘If I was pretty and looked like those porn stars maybe he would be attracted to me.’
It seemed like a perfect, commonly-used, feel-good fix, and she was confident in her surgeon’s advice.
Why I got implants: Hanks, like many women, blamed her post-childbirth figure for her marriage woes. She decided to get implants. Pictured (left) before implants in 2006, and (right) on vacation with her three daughters in 2014, with her first set of saline implants
Hanks went to get a mammogram in 2015 (shortly after this photo was taken) to scan a lump in her breast. The force of the machine tugged on her implant. She heard a ‘rip’ and the saline implant shifted out of place, leaving her in ‘screaming pain’ and ‘lopsided’
HISTORY OF BREAST IMPLANTS IN THE U.S.
1960s: Breast implants were first sold in the US, before the FDA regulated medical devices.
1976: Law changed, meaning that every medical device would be categorized into class I, II or III.
Those in the highest class (Class III) would require the most stringent checks – mainly: human clinical trials.
Breast implants, growing in popularity, were allowed to stay on the market while the FDA decided which category it should take.
But doctors started raising concerns in that the devices seemed to trigger side effects.
1978: An FDA advisory panel suggested breast implants should be Class II.
1982: The FDA decided breast implants should be Class III. They called on industry to conduct human studies to investigate a few main concerns:
- the risk of rupture
- the risk of leaks
- scars contracting
- that they are hard to mammogram
- links to lupus
- links to cancer
1990: Congressmen berated industry for failing to present human trials. The only trials to date were silicone injections in rats and rabbits.
1991: Industry submitted human studies but they were deemed poor quality. One only lasted three months.
1992: Internal documents from people inside the industry leader at the time, Dow Corning, were leaked to the press, showing that manufacturers had concerns of risks to human health.
That was the nail in the coffin. The FDA decided to ban silicone implants for women unless they were part of ‘adjunct’ trials to assess their safety.
2003/4: The FDA rejected the data presented by Inamed (now called Allergan) and Mentor (now part of J&J), saying they were poor quality. Seventy-five percent of women dropped out of the Mentor trial before their first follow-up.
The FDA then published guidance on what the trials should consist of. They needed to answer why implants break, leak, and how long implants last.
2005: Mentor and Inamed submitted three-year-long studies, which were criticized as inadequate by the FDA.
2006: The FDA re-approved silicone implants, but ordered device makers to conduct six trials spanning 10 years with at least 40,000 women.
2011: No data had been published. The National Center for Health Research, a patient advocacy group, lobbied congress for answers. The FDA published data online later that year, showing the studies were not completed. Three-quarters of women dropped out of the Mentor study, and 40 percent dropped out of the Allergan study.
She had them for seven years and everything was fine.
In retrospect, she believes that set did do damage – she developed sudden anxiety, which she blamed on her marriage woes, and her third daughter was born two months premature in 2009, inexplicably without fingertips. (Years later, there is now a study trying to track birth defects in children of women with implants).
But Hanks treated them as random incidents and moved on – getting a divorce in 2011, and teaching her daughter to be proud of her differences.
It wasn’t until after Hanks’s second set of implants – this time silicone ‘gummy’ ones – that she learned about breast implant illness and the myriad of symptoms associated with augmented breasts.
In January 2015, aged 31, she felt a lump in her breast and got that petrified feeling that many women have experienced.
She went in for a mammogram, which involves resting the breast on a machine to be scanned. With implants, it is often a logistical nightmare that requires force because the machine can’t scan through them.
Hanks heard a ‘rip’ and the saline implant shifted out of place, leaving her in ‘screaming pain’ and ‘lopsided’.
The golf-ball-sized lump needed to be removed and biopsied, and thankfully the results came back negative.
But Hanks says, with regret, that she remembers feeling just as consumed by concerns about getting reconstruction surgery.
‘I had such low self esteem,’ she explains. ‘I have a different perspective now. But at the time, I just needed to schedule with a plastic surgeon to get this fixed.’
It was not a complex procedure; women who get breast augmentations are advised to get replacements every seven to 10 years, anyway.
This time, Hanks’s surgeon recommended a newly-re-approved silicone implant, a ‘gummy’ device (because it is the texture of gummy bears) that is meant to feel more natural (‘squishy’ rather than ‘solid’), is meant to have a lower risk of leaking, and is supposed to hold in place better because of its texture.
They are inserted the same way – while the patient is under anesthesia, the surgeon makes a cut under the breasts, arms and around the nipples, inserts the implant either above or below the chest muscle (depending on the anatomy) then sutures everything up.
‘I WAS BURNING ALIVE’: LIFE AFTER GETTING SILICONE GUMMY IMPLANTS
Hanks wasn’t aware that the companies that make silicone breast implants, Allergan and Mentor, have never (to this date) completed the necessary human trials needed to prove their safety.
The only completed studies involved injecting silicone into rats. The human studies provided no incentive for women to stick with the lengthy follow-ups. Three-quarters dropped out early from the Mentor study, and 40 percent dropped out of the Allergan study.
No surgeon mentioned to Hanks that silicone implants were banned in the US for 14 years (1992-2006) over concerns that they could leak, break, cause autoimmune diseases and cancers – and, crucially, that those concerns remained.
There was no mention that ‘gummy’ implants had entered the market in 2012 without a public FDA hearing, and that there were no studies on how the new metals and chemicals they contained affected human bodies.
She didn’t know that the FDA was being sued for allegedly hiding reports of side effects – allowing pharmaceutical companies to avoid reporting serious reactions, as is required by law for Class III devices (the most dangerous category).
But Hanks says it became clear within hours of surgery, on January 10, 2015, that something wasn’t right.
By late spring, Hanks could barely eat any food – ‘to eat meant to be in pain’ – and she quickly lost almost half her weight
Hanks pictured shortly after her implants. She had muscle aches, indigestion, and inflamed rashes all over her body, particularly her arms. Soon her hair started falling out, her skin was shedding.
Hanks’s eyes started turning purple and red, and burning and her vision was clouding
‘As soon as I woke up from that surgery I felt brain fog,’ she said.
‘Everyone blamed it on the anesthesia – “you just had surgery”. All of that.’
But it progressed.
First, her eyes started turning purple and red. Then they started burning and her vision was clouding.
Separately, she started experiencing regular confusion and anxiety about everything.
I looked down at my emaciated body, thinking: “this is what it feels like to die”
She had muscle aches, indigestion, and inflamed rashes all over her body, particularly her arms.
Her hair started falling out, her skin was shedding.
For the first time in her life she was allergic to mown grass, breaking out in rashes in spring. She developed food intolerances – ‘I would drink a glass of milk and I would get these allergic reactions.’
Dermatologists suggested steroid cream and injections. She was put on antibiotics, diets, prescribed more sleep and less stress.
But it kept getting worse.
By late spring, she could barely eat any food – ‘to eat meant to be in pain’ – and she quickly lost almost half her weight.
Doctor after doctor kept suggesting steroids, autoimmune medications, or a new diet, but none worked.
Soon she was having regular seizures, and was in constant excruciating, burning pain.
‘I would have screaming crying fits, my mom would hear me screaming “please don’t throw me in the fire.”‘
Hanks would scream in burning pain. At her lowest points, her parents would rush her to the ER in desperation, but doctors would suggest steroid cream for eczema
Hanks’s mother started sending pictures and video of Hanks’ shedding skin and trembling pain to the top medical institutions locally and nationally – the University of Utah, WebMD, Mayo Clinic – asking for answers
At her lowest points, her parents would rush her to the ER in desperation.
Every time, doctors would hook her up to an IV, test her for autoimmune diseases, and eventually suggest steroids.
On one of her last visits – before she gave up on the ER – a nurse suggested it might be a bad case of eczema.
‘That was my favorite,’ Hanks said.
‘I was burning alive from the inside out and it was the most pain I have ever felt. And they tell me it’s eczema.’
Her mother started sending pictures and video of Hanks’ shedding skin and trembling pain to the top medical institutions locally and nationally – the University of Utah, WebMD, Mayo Clinic – asking for answers. A local OBGYN Dr Jeffrey Baker, a family friend who delivered Hanks’ first daughter, did the same, taking the case to colleagues to discuss.
Hanks says nobody suggested the breast implants could be to blame, though they were listed on all her medical records.
The months went on and her illness progressed.
‘I SAID GOODBYE TO MY CHILDREN’
In late 2015, Hanks and her ex-husband (with whom she is still close friends) decided the ordeal was too traumatic for their three daughters, then aged 10, nine and seven.
‘The trauma of seeing their mom going from healthy and active to dying was more than they could take,’ Hanks said, crying.
‘They would get nightmares.
‘My youngest daughter stopped talking, she stopped communicating. Whenever she visited mommy she would close her eyes, she stopped looking at me.
‘So I made the decision to say goodbye to my children. I believed that this was the end for me. I remember the smell of death, what it tastes like, what it smells like.
‘I couldn’t walk to the bathroom myself.
‘I looked down at my emaciated body, thinking, “this is what it feels like to die, this is what it looks like, this is what it feels like.”’
Agony: Hanks says her three daughters were traumatized by her rapid deterioration
TRYING TO GET THE IMPLANTS OUT: ‘NO ONE WOULD DO IT…WE WERE SEARCHING ON YOUTUBE HOW TO DO IT OURSELVES’
In April 2016, Dr Baker told Hanks there was limited scientific literature to support his theory but he strongly suspected the implants were the source of her agony.
‘She was literally on death’s door,’ Dr Baker, MD, told DailyMail.com.
‘Her central nervous system was shutting down. All her labs were just pristine, but that doesn’t tell you really what’s going on inside the lymphatic system.’
At first he tried to find other sources ‘because she really liked her implants’, but eventually they ran out of options for what could be happening.
‘People don’t connect the fact that when you put a foreign substance in your body it might react. Your body is programmed to heal but when we put implants in, that may inhibit the body’s ability to heal.’
Hanks went back to her surgeon and asked him to take them out.
He said he couldn’t, saying there is no evidence her symptoms were caused by implants and she was too weak for a non-urgent procedure.
It’s something many women report: that they are unable to get insurance coverage and/or a willing surgeon to remove the devices.
Hanks says the pushback led her into a desperate spiral.
‘We were looking at YouTube videos and contemplated removing them ourselves, I was that desperate,’ Hanks said.
‘We have a friend who is a mortician. I planned my funeral.’
Hanks kept her silicone implants after the explant. ‘I considered burning them but I decided to keep them,’ she said. Hers did not rupture, which is one of the only recognized side effects, but she developed autoimmune disorders which disappeared after they were removed
According to Dr Diana Zuckerman, now a patient advocate after years in Congress overseeing committees on medical devices, there are two main reasons women struggle to get explants, as removals are officially known.
First: resistance from surgeons, who say there is ‘no evidence’ the devices cause autoimmune disorders because no studies have investigated the link.
Second: insurance will only cover the $8,000-10,000 procedure if there is a ‘medically recognized’ side effect.
‘What’s commonly called “breast implant illness” – mental confusion, joint pain, hair falling out, chronic fatigue, saying “I thought I was going to die” – none of that is recognized by any insurance company that we know of,’ says Dr Zuckerman, founder of the National Center for Health Research (NCHR), a patient advocacy group.
More than 4,500 women have contacted the NCHR for help lobbying their insurance to pay for explants, with mixed results. If their symptoms are like Liza’s, it’s not possible.
Companies that make breast implants acknowledge certain risks: that the implant could slip, leak or rupture, cause breast pain, hardness and cosmetic issues.
If that is the case, a woman can qualify for insurance coverage to get the implants removed.
Other reactions are not recognized.
However, a growing swell of studies suggest most women who suffer symptoms like Hanks do not have any of the ‘recognized’ symptoms.
An ongoing study by the NCHR has surveyed around 400 women who suffered illnesses after breast implants. Less than a third of had ruptures, and only half had breast pain. The vast majority (84 percent) had other autoimmune reactions. Eighty-nine percent of them saw their symptoms dissipate after they had their implants removed.
That falls in line with the few other non-industry-funded studies that have been done.
An Israeli study of 11,500 women in 2018 found implants increased the risk of autoimmune or rheumatic disorders by 22 percent. Risks of MS, Sjogren’s and sacoidosis increased 60 percent each.
Two studies in the Netherlands (in 2013 and 2016) found between 69 percent and 75 percent of women with autoimmune symptoms were better after an explant, and 20 percent of them recovered completely.
‘I COULD BREATHE AGAIN’: INSTANT RELIEF AFTER EXPLANT SURGERY
Eventually, Hanks’s surgeon agreed to remove the implants under local anesthesia after she got a note from Dr Baker. She had to pay for the procedure.
‘When I woke up post-op in the recovery room and I took my first full breath, I didn’t feel that weight,’ Hanks said.
‘I didn’t have that feeling of burning inside out. I felt light inside, it was a very airy feeling.
‘Two weeks later I bounced into my surgeon’s office and said “hi I’m alive!” They couldn’t believe the life that was breathed back into me.
‘He said I guess implants aren’t for everyone.’
During her recovery, her relationship with her fiance of four years broke down. Later, Hanks met her now-husband Dr Kevin Hanks, an ear nose and throat doctor who she met as she was searching for treatments for her flare-ups
The couple married last June on the Virgin Islands and Hanks says she’s ‘never been happier’
Her three daughters were her bridesmaids for the beach wedding (pictured)
Hanks says she saw an immediate transformation. Her eyes were no longer red raw, her hair gradually stopped falling out, and her food intolerances started to wane.
It wasn’t complete recovery and it was slow at first, so her doctor put her on cyclosporin, an immunosuppressant drug normally intended for post-transplant patients or people with Crohn’s or psoriasis.
Now and then she gets flare-ups – some rashes, food intolerances and confusion, which she says is triggering for her daughters – so she continues to take a similar autoimmune drug. But overall, she says, her symptoms have faded.
During her recovery, her relationship with her fiance of four years broke down. Later, Hanks met her now-husband Dr Kevin Hanks, an ear nose and throat doctor who she met as she was searching for treatments for her flare-ups.
The couple married last June on the Virgin Islands and Hanks says she’s ‘never been happier.’
SHARING HER STORY, AS THOUSANDS OF WOMEN LOBBY THE FDA TO BAN ‘GUMMY’ IMPLANTS
Hanks first started documenting her ordeal because there was a rumor in her town that she was a drug addict.
‘People didn’t know what was wrong with me, they thought “oh, she must be on meth.”
‘I felt like I had to come on a public forum to say: it’s not drugs, the only thing I was addicted to was self-love, to plastic surgery implants.’
Quickly, her posts gained a following.
Dozens of women started popping up in her inbox saying they had experienced side effects and they had implants.
‘They were asking me: “could this be it?”‘
Spreading the word: Hanks and her husband are now trying to raise awareness for other women
Industry says it couldn’t. More than 50,000 women who have joined breast implant illness Facebook groups say it could.
The FDA has said ‘there is no evidence’ that implants cause autoimmune reactions because there are no studies to support the link.
But Dr Zuckerman says her group’s scientific scrutiny of the research has found that claims of ‘no evidence’ are ‘inaccurate’ – branding the industry-funded studies ‘pathetic’.
One of the studies used to disprove the link between breast implants and autoimmune diseases featured 250 women with autoimmune diseases. Only one of them had breast implants, which the authors suggested showed the link was insignificant.
Another report reviewed by the FDA found there wasn’t enough evidence to make a clear decision. ‘Somehow that was interpreted as “these implants show no harm, they are perfectly safe.’
It’s not unique to breast implants, Dr Zuckerman says. The device industry in general has very little scrutiny.
‘There aren’t a lot of checks and balances,’ Dr Zuckerman told DailyMail.com.
Breast implants are basically a $5 product that’s sold for $1,000. So there’s a lot of money to be made. And that’s why so much money has been spent to keep these on the market
Dr Diana Zuckerman, director of patient advocacy group the National Center for Health Research
‘When I first started studying [breast implants, in 1991], I put together a Congressional hearing. At the time I assumed that this was an unusual situation, that they hadn’t studied breast implants carefully but that the FDA normally did study devices carefully.
‘I’ve since learned that the FDA doesn’t examine any medical implants all that carefully.’
The thing that makes breast implants unique is that they are cheap and demand is soaring.
‘Breast implants are basically a $5 product that’s sold for $1,000. That’s kind of a big mark-up, so you can imagine how lucrative that is for companies. Then you have surgeons who say they can do the surgery in 20 to 30 minutes but they charge thousands of dollars for it, and they don’t even have to deal with insurance companies.
‘So there’s a lot of money to be made. And that’s why so much money has been spent to keep these on the market.’
To settle the debate, clinical trials are needed involving plastic surgeons and a lot of funding. Dr Zuckerman says she is skeptical about that coming to fruition.
‘The problem is that the kind of studies that would be best are very expensive […] and you would have to get plastic surgeons to operate without controlling it. And that’s what seems to be impossible. They want to show that implants are safe and that they haven’t been putting unsafe implants in patients.’
Next month, the FDA will hear from industry chiefs and patients – a mix of industry-nominated patients and self-nominated patients – to discuss the risks of gummy implants.
The main focus of the hearing will be ALCL, a rare cancer of the immune system which appears to be linked to breast implants. The FDA acknowledged a link in 2011, and last week released a report strengthening that stance.
Dr Binita Ashar, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, urged all medical providers ‘to learn about BIA-ALCL in patients with breast implants.’
‘We want to ensure that all providers who treat patients with breast implants have information regarding identification, diagnosis and treatment,’ Dr Ashar said.
‘Patients are more likely to seek routine care from primary care physicians, gynecologists and others besides their treating plastic surgeon. By providing information to health care providers, we believe more providers will be empowered with information to assist patients who may have BIA-ALCL.’
While there is no sign they will address autoimmune disorders, patient advocates hope the growing attention for ALCL – a cancer of the immune system – will drive regulators to look at non-cancerous immune disorders.
Jamee Cook, head of Breast Implant Victim Advocacy (BIVA), said the FDA has showing willingness to meet them there.
Her concern is that industry leaders, for obvious reasons, are not.
‘We are a bit skeptical about the data that may be presented by industry [at the upcoming meeting]. The studies are just not there to prove safety and efficacy,’ Cook said.
‘We have numerous women who were supposed to be enrolled in long-term studies and dropped. Some were dropped with no warning. Some were dropped after reporting adverse symptoms. We have several women who would have had their BIA-ALCL diagnosis caught in the study had they been officially followed for the full 10 years.’
Cook’s concern is that the panel will be made up of industry-paid plastic surgeons and patients.
She is spearheading a fundraiser to bring as many of her group’s 50,000 members to Washington, DC as possible next month.
‘I can assure you that the thousands on thousands of women who are sick are not coming forward for money. They are coming forward and explanting because they are sick. Truly sick,’ Cook said.
Hanks is one of those women. She has since undergone a fat-transfer breast augmentation – something which some members of the ‘breast implant illness community’ frown upon. Once you survive breast augmentation ‘you should be happy flat,’ Hanks explains.
Hanks says she feels empowered by hers, and just happy to know that there aren’t the same concerns about fat transfer.
‘Near-death taught me how to live. I try to live every day and love every day like it’s my last,’ Hanks says.
‘Not everyone gets to survive… So I feel like part of my purpose is helping women find the self-love they so desperately seek.
‘I’m not against cosmetic surgery if that’s your version of self-love but I just want the information out there, and want women to be able to have it accessible, to be able to make an informative decision.
‘Women are smart and I know that they can make the right decision for their bodies.
‘But they just need the information, they need the studies. There has to be more information out there for the risks of breast implants.’