Matthew Perrone, Associated Press: March 25, 2019.

Government medical advisers said Monday it’s too soon to ban a type of breast implant that has recently been linked to a rare form of cancer, saying more information is needed to understand the problem.

The Food and Drug Administration panel didn’t recommend any immediate restrictions on breast implants after a day reviewing the latest research on the risks of the devices, which have been subject to safety concerns for decades.

The FDA has been grappling with how to manage emerging science that shows the implants can trigger a rare form of lymphoma that grows in the scar tissue surrounding the breasts. The agency identified about 450 cases of the cancer worldwide, including 12 deaths. Almost all of the cases involve a type of textured implant that is designed to stop implants from slipping and to minimize scar tissue.

But the majority of the 19 panelists — including plastic surgeons and cancer experts — said it was too soon to remove the products from the market.

“Do we want to get into the situation where we pull one sweetener and the replacement is even worse?” said Karla Ballman, a biostatistician at New York’s Weill Cornell School of Medicine. “I think a knee jerk reaction of just pulling something without knowing what the replacement will be might get us into more trouble.”

Estimates of the frequency of the disease range from 1 in 3,000 women to 1 in 30,000. It grows slowly and can usually be successfully treated by removing the implants. The FDA said it has also received reports of the disease in smooth implants — which account for most of the U.S. market.

Another panelist said a ban on textured implants would be an “extraordinary overreaction.”

But that opinion wasn’t unanimous. The panel’s consumer representative stressed the risk to women who get implants for reconstructive purposes after breast cancer surgery and could face a second cancer.

“I think that’s so much of a risk that they need to be taken off the market,” said Roberta Brummert. Her comments set off cheers from dozens of women who attended the hearing.

In the U.S., roughly 400,000 women get breast implants each year; 100,000 women get them after cancer surgery.

On Tuesday, the same FDA panel will make recommendations on studying and defining the risks of long-term chronic conditions with breast implants. Thousands of women have blamed their implants for a host of other chronic ailments, including rheumatoid arthritis, chronic fatigue and muscle pain.

Patients and advocates have used the recent scrutiny to call for new warnings and restrictions on implants.

“Don’t ignore us. We are real,” said Holly Davis, of Charleston, South Carolina.

Davis, 60, said she experienced chronic pain, hair loss, rashes and memory loss after receiving silicone gel-filled implants following a double mastectomy in 2002. Davis said she learned her implants had ruptured when they were removed in 2017; her symptoms have since resolved.

She and other patients want the FDA to require manufacturers to give standardized risk disclosure information to all women considering implants.

“We need to know what we’re signing up for — it can’t be a surprise down the road,” Davis said.

In the U.S., most women choose silicone implants, which are considered more natural looking than saline implants. Both types have a silicone outer shell.

The panelists also heard from researchers who theorize, based in part on animal studies, that silicone that leaks from implants can trigger or exacerbate immune system disorders in certain patients.

In 1992, the FDA temporarily pulled silicone gel implants from the market because of fears they might cause breast cancer, lupus and other disorders. But when studies seemed to rule out most of the disease concern, regulators returned them to the market in 2006.

But critics of that research noted its shortcomings at Monday’s meeting.

“The studies at that time were not very good and did not have the statistical power to determine rare diseases,” said Diana Zuckerman, president of the nonprofit, National Center for Health Research, which published an analysis of more than 20 breast implant studies last year. The group concluded that virtually all were too small or too short or didn’t focus on patients who had their implants long enough to develop problems.

The FDA says on its website there is no “apparent association” between breast implants and chronic, debilitating diseases, such as connective tissue disease.

However, earlier this month, the FDA appeared to signal a shift in its thinking. The agency said it would begin studying whether certain materials used in breast implants, metal hips and other devices can trigger health problems in patients.

“We believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune-inflammatory reaction when exposed to select materials,” the agency said in a statement.

See the original article here.

Maria Rachel, MedTech Dive: March 21, 2019.

When FDA Commissioner Scott Gottlieb and device center chief Jeff Shuren teased next week’s advisory panel tackling breast implant safety, it was tucked into a broader communication on postmarket safety efforts.

But in the four months since, FDA and a domino line of regulators and scientists have flagged upticks in known cases of breast implant associated anaplastic large cell lymphoma. The form of non-Hodgkin lymphoma has been traced to at least nine U.S. deaths. And University of Southern California plastic surgeons published the first known case of similar disease in a recipient of buttocks implants.

Last week, FDA announced an initiative to scrutinize device materials’ biocompatibility, including in the case of silicone breast implants, pointing to potential harmful autoimmune reactions to the devices.

With days before the two-day meeting, the FDA chided Sientra and Johnson & Johnson-owned Mentor for not adequately meeting post-approval study standards, citing low recruitment and poor data and follow-up rates. The only other market competitors are Allergan, whose textured breast implants lost CE marking last December, and privately held Ideal Implant, the newest entrant to the U.S. market.

The FDA is expected to release background materials and specific panel questions prior to the March 25-26 meeting, but none were published as of late Thursday morning ahead of what appears to be at least the eighth advisory committee meeting on breast implants since 1991, according to an agency timeline.

The agenda Monday is set to focus on BIA-ALCL, and Tuesday slated for discussion of everything else: use of MRI screening for silent rupture of silicone gel filled breast implants, surgical mesh in procedures like breast reconstruction and mastopexy, registries for postmarket surveillance, and real-world data and patient perspectives in regulatory decision making.

Here are some facts to know before the meeting.

Early Approvals and Controversy

Business Impact

It remains to be seen how an increase in data and heightened involvement from FDA and other regulators could impact manufacturers’ sales. As of 2017, worldwide silicone-based breast augmentations were up about 1% to nearly 1.47 million, according to ISAPS. Breast implant removal procedures were up 8%. While the swift exit from the European market tanked Allergan’s international breast implant sales 74% year over year, that business is small compared to some of the pharma’s higher-performing products like Botox or its Restasis eye drops.

Meanwhile, some companies are looking to seize the moment. Nasdaq-listed Costa Rican company Establishment Labs launched an IPO and gained FDA approval for its investigational device exemption trial in 2018.

efferies analysts said in a note to investors Wednesday the company is experiencing a “perfect storm,” in which FDA’s upcoming actions could negatively impact current market players, but consumer interest in plastic surgery doesn’t seem to actually be declining.

“The breast implant market is ripe for the taking,” the analysts wrote.

What the Watchdogs Say

The panel could follow in the footsteps of those who weighed in on Essure, who advocated for better informed consent for patients; FDA ultimately issued the product a “black box warning,” which is reserved for calling out serious or life-threatening risks on a package’s label.

Madris Tomes, a former program manager at FDA who now analyzes adverse event data through her company Device Events, said the black box warning was not effective for patients in the case of Essure, and probably wouldn’t make a significant difference for potential breast implant recipients either.

“The patient won’t see a black box warning because they don’t see the box for the [product] that’s going to be implanted in them,” she said.

National Center for Health Research President Diana Zuckerman agreed that a black box is possible, and while FDA rarely recalls devices and already oversaw a long moratorium in this device category, she said a partial market removal of textured implants in particular wouldn’t be unheard of.

See the original story here.

Mia de Graff, The Daily Mail: March 20, 2019.

Days before a hearing on breast implant safety, US regulators have sent warning letters to two of the top implant manufacturers involved.

In the letters, the US Food and Drug Administration reprimanded Mentor and Sientra for historically failing to complete the safety studies required for medical devices to stay on the market.

If the firms do not have completed data within 15 days, the FDA warned, their blockbuster silicone implants could be pulled from the market.

The warning is a gesture to patients that the FDA intends to be firm with breast implant manufacturers, whose products have stayed on the market for years without adequate safety data, despite ranking in the highest-risk bracket for medical devices.

It comes amid global concerns over the safety of silicone breast implants, which have been officially linked to cancer of the immune system, and are alleged to cause autoimmune disorders.

Lauren Dunn, NBC News: March 19, 2019.

Less than a week before a major hearing on breast implant safety, the FDA issued two warning letters to implant manufacturers, citing their failure to do proper safety studies.

The letters sent to Mentor and Sientra warned that certain implants could be pulled off the market if the companies didn’t fulfill the agency’s requirements, which ask that manufacturers continue safety studies even after the devices are approved.

According to the letters, Mentor failed to enroll enough people in these studies. Sientra had poor follow-up rates.

“The FDA has the authority to say you either have to study it or take off the market and the company has the incentive to do one or the other,” Diana Zuckerman, president of the National Center for Health Research, told NBC News.

Zuckerman also called the letters “surprising but encouraging,” and questioned whether the FDA would take action if the companies failed to comply with the warning letters.

“You can’t assume that just because they sent the warning letter, it’s anything more than the FDA flexing their muscles,” Zuckerman said. “If the companies don’t get scared enough to comply, the big question is whether the FDA will follow through.”

In a statement to NBC News, Mentor, said it had made “multiple attempts” to discuss study requirements for its MemoryShape breast implants with the FDA.

Denise Grady and Roni Caryn Rabin, New York Times: March 19, 2019.

Faima Bakar, Metro News: March 11, 2019.

Erika Rae Ritschard had surgery seven years ago to get implants to increase the size of her breasts to double Ds.

But after the cosmetic procedure, the 28-year-old noticed that she was experiencing anxiety and depression.

The mum-of-three from Mississippi, says she had symptoms which included weight loss, heart palpitations, memory loss, extreme fatigue, skin rashes, anxiety, depression, and even suicidal feelings.

As a result, Erika decided to get rid of the sillicone implants as she believed they were poisoning her. She paid $5,000 (£3,831.30) for the explant procedure.

The photography editor believed she was suffering from ‘breast implant illness’ after stumbling on a Facebook support group for the condition.

Although there is no official connection between breast implants and the condition known as ‘breast implant illness’, thousands of women have joined online support groups reporting similar symptoms.

‘It’s horrifying to think that what I had chosen to put into my body was making it wither away.

‘I wanted to cut them out of myself. During my worst times, I even contemplated suicide.

‘After breastfeeding two babies and losing some weight, I wasn’t really into the appearance of my breasts.

‘My husband told me I looked perfect but I was really set on getting implants. I felt like I had given my body to my kids and this was something just for me.

‘Within three months, I was dealing with anxiety and depression.’

She reported going to the ER over extreme migraines, she lost 40 pounds, had aching muscles and her hair also became very brittle.

Erika says she was tested for parasites, had pelvis and stomach ultrasounds, MRIs and CAT scans but doctors never diagnosed her.

A few years later, Erika came across Facebook group Breast Implant Illness and Healing and felt like she finally had her diagnosis.

She said: ‘The description in the group fitted with exactly what I was experiencing. I felt like I was reading about myself.

‘I thought: “Holy crap, that’s why the doctor can’t find anything wrong with me!”

‘I posted a bit of my story on the page and hundreds of women wrote to me and said it was definitely breast implant illness.’

Just three months later, Erika had her breast implants removed at a surgery in Alabama.

She said: ‘I immediately felt myself again but at first I was worried it was the pain medication I was on after the operation.

‘But two weeks in, I knew this was a real heal. I put on forty pounds in four months. All my muscle pain was gone. I could sleep through the night.

‘My skin was soft again, no more alligator patches. All of my symptoms subsided in the first two months.’

Dr Diana Zuckerman, President of the National Center for Health Research in Washington D.C, said that just because breast implant illness is not recognised by the Food and Drug Administration (FDA) it doesn’t mean that the condition is not real.

‘When there’s a new pattern of a group of symptoms that seem to all cluster together for a group of people it often takes a long time until the medical community accepts that it is a real thing,’ said Dr Zuckerman.

‘We certainly have seen and talked to many women who have experienced this cluster of symptoms that are referred to as breast implant illness.

‘What they have in common is that they are symptoms that could be caused by their immune system going out of whack.’

See original story here.

Sasha Chavkin, ICIJ: February 27, 2019.

Our team of more than 200 journalists spent a year investigating medical implants because of people like Karen Randell.

Randell, who lives in Auckland, New Zealand, says a product intended to repair her abdominal wall and prevent hernias has instead caused unending agony. “I barely leave my home because of the pain,” she told us.

Her implant, called Ethicon Physiomesh, was recalled globally by Johnson & Johnson in 2016 because of abnormally high complication rates. Thousands of women have sued, claiming the mesh caused bleeding, severe pain and a host of other complications.

Randell, who says she is simply “existing,” is one of 3,000 people from 55 countries patients who responded to an ICIJ callout — a number that doesn’t include hundreds of patients who we spoke with while reporting the initial stories.

These patients, in turn, are just a tiny sliver of a global population of people harmed by medical devices that are often approved for sale with little or no clinical safety evidence. The Implant Files, a global collaboration led by the International Consortium of Investigative Journalists, found that health authorities are failing to safeguard patients from medical devices that have been linked to more than 83,000 deaths and more than 1.7 million injuries in the past decade.

In the three months since we published our first stories, regulators around the world have vowed to fix gaps in medical device oversight.

Some of the promised reforms appear poised to transform national health systems. Other declarations, our reporting has found, initially sounded bold and sweeping — but have not been backed up by action.

Here is what we know so far.

Canadian health authorities have done more than hint at change: they’ve created a plan that includes both specific steps and a timeline for implementation. Coming changes include new evidence requirements for high-risk devices, mandatory reporting of adverse events by Canadian hospitals and more medical device facility inspectors.

Other countries have taken substantial first steps, but the end result remains unclear.

The German health minister vowed to build a national registry to track device safety and performance. The government introduced legislation that would compile the register within three to five years, but the bill hasn’t been voted on yet.

In the Netherlands, the health minister has called for a long list of reforms. But many of the most concrete steps are contingent on new Europe Union regulations that will not be implemented until 2020.

In India, regulators convened for the first time to discuss a “road map” for device oversight  — more than a decade after legislation to regulate medical implants was proposed but never enacted.

The greatest disconnect between rhetoric and reality may be in the United States. The day after the Implant Files launched, Commissioner Scott Gottlieb of the U.S. Food and Drug Administration pledged to boldly reform the agency’s widely used fast-track pathway for device approval, known as the 510(k) process.

He also vowed to  improve the agency’s monitoring  of patient harm linked to devices, vowing that the FDA would be “consistently first among the world’s regulatory agencies to identify and act upon safety signals.”

Some of what Gottlieb proposed has been in the works for years. Other pledges wouldn’t alter what experts say is the fundamental flaw with many approvals — the absence of clinical evidence that show devices are safe and effective.

The agency’s call for manufacturers to use newer devices when seeking quick certification based on “substantial equivalence” to an existing device does not enhance safety testing standards.

The monitoring reforms — an initiative to compile and analyze medical device data known as the National Evaluation System for Health Technology(NEST) and a program to enhance oversight by adding a serial number or barcode to each individual device called a Unique Device Identifier (UDI) — are longstanding FDA initiatives that have languished for years without being fully implemented.

The FDA said it is considering additional steps to improve the 510(k) process, some of which may require approval by Congress, and that it is soliciting comments from the public on how it should proceed. The agency said it plans to have a preliminary version of NEST operational by the end of 2019, and that as of this month, 190 vendors of electronic health records can scan UDI codes into their records and are certified to meet UDI standards.

“We believe these and other efforts we have planned will have a significant impact on modernizing the 510(k) process and on our commitment to enhancing the safety and effectiveness of medical devices for patients,” the FDA wrote in response to questions from ICIJ.

A medical registry is a collection of health and demographic information about a group of patients with a specific characteristic, such as those with a particular type of implant.

New registries take several years to compile enough patient data to allow researchers or health authorities to draw substantial conclusions.

In addition to Germany, the United Kingdom is considering a nationwide registry of medical devices, and has drawn up plans to enact it.

The U.S. has launched registries in recent years for breast implants and mesh, which the FDA now emphasizes as key elements of its plans to enhance its oversight of these devices.

Regulators in the Netherlands and Italy have also expanded or strengthened reporting requirements for their countries’ registries.

Diana Zuckerman, the president for the National Center for Health Research and an advocate for patients harmed by flawed devices, says that all registries are not created equal. Effective ones must require physicians to report to them, must be open to the public, and must track the full range of health problems affecting patients, Zuckerman said.

It is not yet clear if the new registries under consideration will meet all of these criteria.

A wave of regulatory action has roiled the breast implant industry, and more is likely coming. ICIJ had revealed that thousands of injuries linked to breast implants had been hidden from public view as new health risks related to the devices emerged.

The fallout began when the European certification for textured breast implants produced by Allergan expired about a month after the Implant Files’ publication. Rather than renewing the certification for another five years, which usually occurs routinely, a European oversight body declined to certify the products, citing their association with elevated risks of a rare cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL).

The decision, which stopped the implants from being sold across the European market, set off a chain reaction:

Dec. 18, 2018: The French health ministry announced a recall of all Allergan textured implants that remained in French hospitals, prompting the devices to be suspended from the market across the European Union. French authorities also convened an expert committee to investigate a long-term solution. On February 8, the committee called for a permanent ban on one of the two products that had been suspended, Allergan Biocell implants.

Dec. 20, 2018: Health authorities in Brazil, the world’s second leading market for breast implants, suspended Allergan textured implants.

Feb. 6, 2019: In the U.S., the FDA sent a letter to doctors across the country warning them of the association between breast implants and ALCL. It had previously announced a public hearing on breast implant safety that will take place in late March.

Feb. 12, 2019: Health Canada re-opened a safety investigation into breast implants after previously contending that further review was unnecessary. (The U.S. and Canada have both declined to impose restrictions while their inquiries are underway).

In the fourth quarter of 2018, Allergan’s global breast implant sales declined 74 percent from the same period in 2017.

In Spain, ICIJ’s partners at broadcaster La Sexta received more than 5,000 messages from medical device patients within 24 hours of airing the Implant Files. ICIJ has received more than 3,100 responses to an online callout inviting patients to share their stories.

Women have been at the forefront of pushing for change.

Women injured by devices including breast implants, the birth control device Essure and vaginal mesh have formed powerful communities on social media and pressed health authorities to regulate these devices more strictly. Essure was removed from the U.S. market last year after intense pressure from patient advocates.

Randell, the mesh patient in New Zealand, hopes to travel to the U.S. because she can’t find a surgeon in her country who is trained to remove the mesh from her body, but currently can’t afford the trip. She is also pursuing legal claims to try to get compensation for her injuries.

“This is not living,” Randell said.

In a written statement to ICIJ, Johnson & Johnson noted that it had voluntarily withdrawn Physiomesh from the global market in 2016. “We empathize with any patient who has experienced complications after surgery,” wrote spokeswoman Mindy Tinsley.

Representatives for the device industry have said the widespread attention to device problems misses the big picture of the benefits that the industry provides.

“I would hate for a series of stories to leave the impression that medical innovation hasn’t been a remarkably good thing for the human condition,” said Scott Whitaker, the president of AdvaMed, the leading U.S. trade association for device manufacturers.

Advamed pointed to a 2010 study that found that less than 0.5 percent of devices approved under the 510(k) process over a five-year period were recalled for serious or life-threatening problems.

ICIJ’s reporting found that medical devices, including many of types of high-risk implants, have indeed helped millions of people live better, longer lives. Some of the reporters on our team have implants, and are glad for them.

If you or a loved one had a medical device injury, we want to hear your story.

If you have worked for a medical device company, we want to hear your story.

If you are a physician who routinely uses medical implants in your practice, well, you get the drift.

See the original story here.

Mia De Graff, Daily Mail: February 21, 2019.

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.

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, a soon-to-be-released survey of women who have got implants found few were 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. 

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.

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.

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.

‘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.

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.”‘

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.

In late 2015, Hanks and her ex-husband 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.”’

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.’

According to Dr Diana Zuckerman, a scientist who studies patient data and health 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-focused research 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.

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.’

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.’

Hanks started sharing her story on her Instagram account My Fair Liza in 2016, posting candid photos of her blistering skin, and documenting her steady improvement after her explant.

At first, it was to dispel 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 into her inbox saying they had experienced side effects and they had implants.

‘They were asking me: “could this be it?”‘

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. 

‘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, now writing a book about her ordeal called Surviving Perfect, 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.’

See the original story here.

Liz Szabo, Kaiser Health News: January 8, 2019.

Spending on health care marketing nearly doubled from 1997 to 2016, soaring to at least $30 billion a year, according to a study published Tuesday in JAMA.

Jeanne Lenzer and Shannon Brownlee, Washington Post: January 4, 2019.

Ten years ago, Kathleen Yaremchuk raced to the bedside of a patient inexplicably gasping for breath. Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, Yaremchuk performed an emergency tracheotomy on the woman, cutting a hole in her windpipe, inserting a breathing tube and saving her life. When Yaremchuk began getting more calls over the following months for mysterious cases of respiratory distress, she launched a study to figure out what was going on.

All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. The object, used to hold a protein that stimulates bone growth, was cleared for sale by the Food and Drug Administration in 2003 without clinical testing in humans. When Yaremchuk and her colleagues reviewed the records of all 260 patients implanted with the device at Henry Ford Hospital between 2004 and 2009, they found that a significant number developed airway obstruction, trouble swallowing and respiratory failure, in some cases leading to death.

The neck implant is just one of the products associated over the past decade with 1.7 million injuries and more than 80,000 deaths. A searing global investigation last year by the International Consortium of Investigative Journalists places much of the blame on significant failings in the FDA’s oversight. The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and hemorrhage; and defibrillators that repeatedly shock patients beyond human endurance. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad. No wonder many patient advocates cheered when the FDA announced in November that it planned to make “transformative” changes in the way more than 80 percent of medical devices are cleared for sale in the United States. Some 32 million Americans walk around with such products in their bodies.

But the promised transformation is mere window dressing. Two key loopholes still exist, allowing most products to be approved for sale without clinical trials in humans. Although the FDA insists that high-risk devices undergo “stringent” testing to win approval, few actually do. A 2009 study, for example, found that only 5 percent of the highest-risk implantable cardiac devices were subjected to clinical trials on par with the testing required for drug approval.

In 1976, when medical devices first came under the regulatory control of the FDA, the agency simply grandfathered in all devices that were already on the market. Under this provision, known as the 510(k) pathway, new artificial joints, cataract lens implants and thousands of other devices developed after 1976 can win approval for sale (or “clearance” in FDA parlance) if the product is shown to have “substantial equivalence” to a previously cleared “predicate” device.” Four out of five devices are cleared for sale this way. Of those, at least 95 percent were cleared without clinical studies, according to research by Diana Zuckerman and her colleagues at the National Center for Health Research.

For some devices, that makes sense. You don’t need a clinical trial to test a new tongue depressor or hospital stretcher. But the agency also lets higher-risk devices through based on predicate devices, some of which have been recalled for safety problems. A 2018 study by researchers at the University of Oxford discovered that 16 percent of surgical meshes cleared for sale in the United States between 2013 and 2015 were based on products previously removed from the market because of serious complications. When one of us asked the FDA how this could happen, officials answered that the agency doesn’t evaluate the performance of the predicate when clearing devices for sale, just that there is (or was) a predicate.

According to the FDA, the “most impactful” change it is considering is recommending (not mandating) that companies cite predicate devices no older than 10 years. Yet device-makers could still cite predicates that were themselves based on earlier devices that may date back well past 10 years, something the FDA acknowledged in an email to us, stating that “devices cleared under a 510(k), regardless of how long the predicate has been on the market, have met the 510(k) regulatory review standard.”

The second loophole is the supplement pathway, which applies to new versions of the highest-risk devices, such as artificial hips, deep brain stimulators and spine implants. This process allows manufacturers to inform the FDA that they want to market an updated version of a device with minor changes — once again, allowing them to circumvent clinical trials. Researchers at Harvard found that 99 percent (5,829 of 5,906) of implanted cardiac devices, such as pacemakers and defibrillators, were approved through the supplement pathway from 1979 to 2012.

The supplement pathway has led to a number of disasters, such as one involving Medtronic’s Sprint Fidelis defibrillators, which are implanted in the chest to shock the heart if it goes into a deadly rhythm known as ventricular fibrillation. The company told the FDA in 2003 that it had updated the device to use thinner electrical leads into the heart. But the new wires were prone to fracture, hitting some patients repeatedly with shocks when their hearts were fine, and not delivering shocks to others who needed them. Doctors put the Sprint Fidelis into Bridget Robb, a patient from Pennsylvania in her early 30s. It shocked her 31 times in a span of minutes in 2007. She said in congressional testimony that it felt like being shot in the chest by a cannon at close range.

By the time Medtronic recalled the defibrillator in 2007, about a quarter-million were in circulation worldwide. Individuals implanted with it live under a sword of Damocles: They risk electrocution and possible death if they leave the Sprint Fidelis alone — and they risk death if their heart stops and the product fails. If they choose to have it removed, they face a 12 to 16 percent rate of serious complications or death from the surgery, according to a study published in 2010 in the journal Circulation.

Cases like these have received widespread coverage in the press but have had virtually no effect on FDA policy. Even a damning 2011 report by the Institute of Medicine (requested by the FDA), which deemed the agency’s 501(k) pathway so flawed it should be thrown out, fell on deaf ears.

Part of the problem lies in whom the agency believes it serves. At a 2018 meeting in Utah, the FDA’s device director repeatedly referred to manufacturers as the agency’s “customers” and showed a slide proclaiming “90 percent customer satisfaction.” Another slide documented the agency’s shorter and shorter approval times over the past eight years. These might not be the priorities of patients and taxpayers if they knew how often devices go on to harm people.

The FDA has become a captive agency. In 2007, Congress passed the Medical Device User Fee Amendments (MDUFA), which requires manufacturers to pay for device approvals. (Similar legislation, the Prescription Drug User Fee Act, directs money from drug companies to the FDA.) By 2018, 35 percent of the FDA’s budget for regulating devices came directly from the companies that make them. Zuckerman says that to continue collecting user fees under the MDUFA, the agency has to meet “performance goals” for faster approvals — leaving less time to evaluate products before they go on the market. It’s an inherent conflict of interest exacerbated by the revolving door of directors and commissioners who come from industry to the FDA and then go back. Before being appointed by President Trump to head the agency, Scott Gottlieb was paid millions of dollars for consultancies, directorships and other ties with some 20 health-care companies. He is a vocal supporter of Trump’s deregulation drive, arguing in 2013 that “the FDA’s caution is hazardous to our health.”

This is not a new problem. Before Gottlieb, President Barack Obama appointed Margaret Hamburg, who was then a director of Henry Schein, a leading medical-device distributor, to head the FDA. And in 2005, President George W. Bush named Lester Crawford, who abruptly resigned after just two months and came under criminal investigation for making false statements to Congress concealing his ties to companies the FDA regulates.

The relationship between the agency and the device industry is so cozy that in 2015, Rob Califf, then the FDA commissioner, met secretly with the Advanced Medical Technology Association (AdvaMed), the industry trade organization, to help craft the 21st Century Cures Act, which lowered the bar of evidence needed to approve devices even further.

Last fall, the FDA and AdvaMed were aware of the planned release of the Implant Files, the report by the investigative journalists’ consortium. AdvaMed executives were so concerned that they held a meeting to discuss strategies for dealing with the anticipated stories, which made headlines around the world in November. The executives promised their member companies that they would “hit back and hit back hard.” One day after the first reports were published, the FDA issued its “transformative” changes to the 510(k) pathway.

If Americans want devices that are safe and effective, they’ll need a new kind of regulation. First, the FDA should recategorize any implanted device as a high-risk or Class III product, which would subject it to rigorous clinical trials. Data from these studies should be made publicly available, or the manufacturer would forfeit the right to sell its product. And implanted devices should be entered into registries that track outcomes; patients should be given access to a website where they can immediately report problems and receive updates.

Lawmakers should also revive the congressional Office of Technology Assessment, which the House of Representatives killed in 1995, during a fit of anti-regulation insanity inspired by Newt Gingrich’s Contract With America. The office provided an invaluable service by independently assessing evidence for a wide range of technologies.

Finally, the FDA commissioner should be a civil servant without financial conflicts, not a political appointee (a practice started under Richard Nixon).

To do all of this, the FDA needs to overcome the constant threat of losing funding if it goes against the wishes of the industry it is supposed to regulate. Congress should repeal the MDUFA (and the prescription-drug equivalent) and fully fund the agency. Until the FDA requires clinical testing of implanted devices, as it does for drug approval, we simply won’t have the evidence to prove that a device is safe or effective.

See the original article here.