Category Archives: We Are Quoted

US Regulators Float Ideas for Boosting Medical Device Safety

Matthew Perrone, The Associated Press: April 17, 2018

U.S. health officials on Tuesday proposed steps to improve the government’s system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments.

The plan from the Food and Drug Administration includes few immediate changes, but lists a number of ideas and proposals with the goal of improving safeguards on pacemakers, artificial joints, medical scanners and other devices.

Among other measures, the FDA will consider requiring more training for doctors who implant certain high-risk devices. But that step, like others floated by the agency, might require new guidelines or regulations. Other proposals may require additional money from Congress.

The FDA has repeatedly been forced to issue safety alerts about unexpected problems with devices that only appeared years after they were approved for use in patients. In the last decade, those have included hip replacements that failed prematurely, faulty wiring in implanted defibrillators, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

“We want to have better tools for detecting issues that occur post-approval,” FDA Commissioner Scott Gottlieb said Tuesday. “But we also want to have better policies to quickly intervene and better inform patients and providers if we see adverse events happening.”

An agency critic said the report contains few concrete changes and “many sections that will please the device industry.”

“FDA’s safety strategies for medical devices are still years away from effective implementation,” said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group. “Overall, the report indicates that the FDA’s approval standards for medical devices remain completely inadequate.” […]

Among other proposals laid out in the FDA’s “Medical Device Safety Action Plan,” the FDA will consider:

— How to quickly require additional safety requirements for certain devices, including training for doctors who work with the complex devices.

— Extra scrutiny of devices for women, following recent problems with vaginal mesh, the birth control implant Essure and surgical tools.

— New ways to encourage manufacturers to improve safety, including quicker approval for devices that appear safer than what’s available.

— Requiring cybersecurity features for electronic devices like implantable heart pacemakers and defibrillators.

The agency will also ask Congress for more money for a public-private system intended to monitor insurance claims, electronic health records and other data sources for early signs of device problems. The project is estimated to cost $250 million over five years to become operational; it is now slated to receive $30 million from device manufacturers.

Read the original article here.

The Problem with Medical Device Approval

Suzanne Robotti, MedShadow: January 16, 2018

MedShadow doesn’t often cover medical devices, but I’ll make an exception to point out this article about Stephen Tower’s experience with an artificial hip. This is a must-read for anyone who has or anticipates getting an artificial hip or knee — or any other body part.

Stephen Tower, MD, is an orthopedic surgeon experienced in performing artificial hip replacements. Yet he found out firsthand that the hip he requested to be put in his body was defective in its design. He then worked for years to bring attention to the harm that the metal-on-metal hip from Johnson & Johnson was causing.

The interesting part of the story is how that device — and almost all medical devices — got approved by the FDA. Essentially, a device manufacturer can file a form claiming that its product is “substantially equivalent” to an existing device. If the FDA agrees, that’s it. There’s no need for testing and no follow-up studies.

In some cases the “substantially equivalent” claim makes logical sense, but doesn’t work in real life — that’s why the clinical trial process exists. The author of the op-ed, Jeanne Lenzer, explored many examples and the history of the FDA in her new book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Save It. […]

I’ll give the last word to Diana Zuckerman, the president of National Center for Health Research (NCHR), an independent nonprofit that scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. NCHR does not accept funding from device or pharmaceutical companies.

I asked Zuckerman for an example of a substantially equivalent approval that had particularly bothered her. She told me that the da Vinci Surgical System was “cleared for market” as substantially equivalent to the surgical tools it uses, such as a scalpel. But a robotic surgery system is more than just the tools it uses. The da Vinci robot was described by then-FDA Commissioner Jane Henney as the first of its kind and a product that “could change the practice of surgery.”

Although based on the 510(k) review process that rarely requires a clinical trial, the FDA required the first version of the da Vinci system to be studied in one clinical trial comparing the results to traditional surgery for gallbladder and reflux disease surgery. However, it and all future da Vinci robotic systems for all other surgeries were cleared for market by the FDA as substantially equivalent to the scalpel and other tools, and those later reviews didn’t require any clinical trials at all.

“How can a device be revolutionizing the practice of surgery and yet be substantially equivalent to tools that scientists tell us have been in use for more than 2,000 years? Does that make sense to any logical person?” […]

Read the original article here.

Why Are So Many American Women Having Mastectomies?

Diana Zuckerman, PhD, and Megan Polanin, PhD, National Center for Health Research, Our Bodies Ourselves: June 15, 2017

When Angelina Jolie publicly announced her double mastectomy four years ago, she was praised for possibly saving many women’s lives. But we know more today than we did then and experts now agree that too many women are undergoing unnecessary mastectomies – even some women with the “breast cancer genes.”  You’ll be surprised by what we’ve learned.

A 2007 review of 10 studies found that the risk of getting breast cancer for an average woman with BRCA1 is 57%. The risk is 49% for a woman with BRCA2. Although frightening, this is far from the inevitable breast cancer diagnosis that many women expect. And, keep in mind that the lifetime risk of breast cancer is very different from the risk of getting breast cancer in the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 14% chance of getting breast cancer before she turns 50. We’re willing to bet that is a much lower risk than most women assume. With regular screening and all the progress in breast cancer treatments, the survival rate from breast cancer is higher than ever. Many breast cancer patients live long and healthy lives.

Most women are diagnosed with breast cancer at early stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). Yet American women are undergoing mastectomies at a higher rate than women in other countries, including prophylactic mastectomies. Breast cancer experts believe that many women undergoing mastectomies do not need them and are getting them out of fear, not because of the actual risks.

For many years, experts have known that women who undergo mastectomies for the non-invasive condition called ductal carcinoma in situ (DCIS) or for early-stage breast cancer do not live longer than women undergoing lumpectomies. However, the latest research goes a step further:  A 2016 study of more than 37,000 women with early-stage breast cancer found that the women undergoing lumpectomies were more likely to be alive 10 years later than women with the same diagnosis who underwent a single or bilateral (double) mastectomy. They were also less likely to have died of breast cancer. In 2016, Harvard cancer surgeon Dr. Mehra Golshan reported that of almost half a million women with breast cancer in one breast, those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast. These are just the latest studies – for more information about the years of consistent evidence that less radical surgery is better, see this article.

And yet, an increasing number of U.S. women with early-stage breast cancer are choosing to have both their breasts removed “just to be safe.” A 2015 study conducted by researchers at Vanderbilt University reported that, for women diagnosed with early-stage breast cancer in one breast, the rates of double mastectomy increased from 2% to 11% from 1998 to 2011. Researchers found that decisions to have a double mastectomy increased more for two groups of women: 1) Women with ductal carcinoma in situ (DCIS) where there are abnormal cells inside a milk duct in the breast that won’t spread and aren’t dangerous unless breast cancer develops later; and 2) Women with cancer only in one breast that has not spread to the lymph nodes. This year, researchers from Emory University reported that the percentage of women over 45 getting double mastectomies for early-stage breast cancer in one breast increased from 4% to 10% in less than a decade. For women ages 20-44, the percentage tripled from 11% to 33%. To some extent, geography was destiny: in five Midwestern states (Nebraska, Missouri, Colorado, Iowa, and South Dakota), 42% of the women who got surgery had a double mastectomy.

The bottom line is that women with DCIS or early-stage breast cancer have more effective and less radical treatment options than mastectomy. Even women with BRCA1 or BRCA2 may never develop breast cancer, and if they do, they may not need a mastectomy. We need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.

So, the good news for women newly diagnosed with cancer is that mastectomies are not the best choice for most women if they want to live longer. Women should be aware of treatment choices for breast cancer and encouraged to make decisions based on their own unique situations. For each woman, it is important to weigh her own risk of cancer — in the next few years, and not just over her lifetime – and the risks of various treatments. Each woman should make the decision that is best for her, based on information, not on fear.

Read the original blog post here

Former Playmate of the Year on Removing Breast Implants: ‘I Literally Thought I Was Dying’

Kris Pickel, AZ Family: May 4, 2017
Karen McDougal
Karen McDougal

It wasn’t a decision Karen McDougal took lightly.

As a former Playboy Playmate of the Year, her career is built on beauty and fitness, but McDougal says her health deteriorated to the point she felt like she was going to die.

In January, McDougal made the decision to explant & have her breast implants removed.

McDougal says she battled health problems – issues she now believes stemmed from her implants — for more than a decade. Her health issues began eight years after she got her implants.  McDougal said she would get sick for six to eight weeks at a time, get better for a month or two and then get sick again.

It became a running joke among McDougal’s family and friends that she was the “healthiest sick person.”

For a decade, doctors failed to diagnose the cause of her sickness.  She said one doctor told her she was suffering from depression. Another told her that her implants looked great there was no need to replace them. […]

I talked to Dr. Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C. She has a long history on breast implant safety.

“From 1983 to 1993, Dr. Zuckerman worked as a Congressional staffer in the U.S. Congress, working for the House subcommittee that has oversight jurisdiction over the U.S. Department of Health and Human Services, including the FDA,” according to her biography on BreastImplantInfo.org. “She was responsible for more than a dozen Congressional investigations and hearings on a wide range of health issues, including the first Congressional hearings on breast implants. It was Dr. Zuckerman’s congressional investigation of breast implants that first raised questions about the lack of safety data, which led to the FDA requiring safety studies of silicone gel implants in 1991. When the companies did not provide evidence that implants are safe, the FDA restricted their availability in 1992.”

Zuckerman said many studies over the years have been funded by organizations representing plastic surgeons and implant makers, all of which have a financial interest in making implants look safe.

She says the companies and organizations sometimes help shape studies with results that are not scientifically valid.

Zuckerman also said some studies might have been manipulated in a number of ways.

“I’ve spoken with some of the women in some of the studies who said as soon as they started complaining to their plastic surgeon about how sick they were feeling, suddenly they stopped hearing from the plastic surgeon about coming in to continue the study,” she said. “Suddenly, they weren’t in the study anymore. One very effective way to have studies proving that a product is safe is to just get rid of the patients in the study who aren’t feeling well — just stop talking to them and stop asking them how they are.”

Zuckerman said there are additional problems with some studies, including basing data on hospital records when most symptoms of chronic illnesses, such as fatigue and hair loss, do not require hospital stays. Also, many studies are done over short periods of time, between two and five years after the implant surgery, when illness may not start showing until several years later.

Zuckerman says if a woman decides to have her implants removed, there is a specific procedure. The implants must be removed with the scar tissue that forms around each implant, the capsule, still in place.

Read the full article here.

FDA Agrees with WHO, Links Breast Implants to Rare Cancer. How Worried Should Women Be?

Rita Ruben, Forbes: March 22, 2017

The Food and Drug Administration has received nine reports of women dying of a rare blood cancer years after getting breast implants, according to information the agency released Tuesday.

The FDA says it now agrees with the World Health Organization that such cases are linked to the breast implants and not some unfortunate coincidence. As of Feb. 1, the FDA says, it had received a total of 359 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The FDA reports suggest that implants with a textured surface are more likely to be associated with the cancer than smooth implants—of the 231 reports that contained information about the implant’s surface, 203 were reported to be textured implants, while 28 were reported to be smooth. The Australian Therapeutic Goods Administration (TGA) analyzed 46 confirmed cases of BIA-ALCL, including three deaths, and none of the cases occurred in women with smooth implants.

BIA-ALCL on average is diagnosed about a decade after implant surgery, according to the WHO. The first reported case of a woman with breast implants developing ALCL was published in a 1997 letter to the journal Plastic & Reconstructive Surgery. While that case was a woman with saline-filled implants, the FDA says the filling, be it saline (salt water) or silicone, doesn’t seem to make much of a difference, although no well-designed studies have yet been conducted to settle that issue.

BIA-ALCL is rare, but just how rare isn’t clear. As the FDA notes, it medical device reports can’t answer that question, because they don’t represent all cases, and the denominator—the total number of women who’ve received breast implants—isn’t known.

ALCL is more common in the breasts of women who’ve had implants than in those who don’t have implants, in whom the cancer almost never develops in the breast. A U.S. studypublished in January concluded that over their lifetime, 3.3 women out of every 100,000 with textured breast implants will develop BIA-ALCL. But the TGA estimates that the disease is more common, affecting 1 in 10,000 to 1 in 1,000 women with breast implants (that agency says it has received no reports of BIA-ALCL in women with smooth implants).

“There is no reason to think it is less likely to develop in women in the U.S., and given the dramatic increase in diagnoses in recent years, it is clear that it was under-diagnosed and under-reported for many years,” Diana Zuckerman, a health advocate who has long questioned the safety of breast implants, told me.  Zuckerman serves as president of both the National Center for Health Research and the Cancer Prevention and Treatment Fund, nonprofits based in Washington, D.C.

Read the full article here.

Right to Try Laws allow Big Pharma to Exploit False Hope


If you or a loved one were dying of a terminal illness and your doctor told you there were no proven treatments, would you take the risk of trying an experimental, unproven drug?

Many patients would say yes. But as with most medical decisions, the more you know, the more you realize the answer is not so simple.

As has been clearly shown, Congress is not very good at making complicated and nuanced decisions about medical care.

That’s reason enough to question the new federal Right to Try Act dozens of senators and representatives are pushing this spring.

The most important thing to know is that all terminally ill patients already have a right to try experimental drugs in this country.

The proposed new law, however, is much more dangerous to all patients, and not just those facing fatal illness. Here’s why:

The current national expanded access program enables doctors to request experimental drugs for their patients. If the company that makes the treatment agrees, the patient will get the treatment for free or at cost; companies are not allowed to sell experimental drugs for a profit.

Many patients get access to experimental drugs through this existing program, and improvements are underway to further streamline the process.

In contrast, under the proposed new law, a drug company could charge desperate patients as much as they want to get access to an experimental drug.

Since insurance companies do not pay for experimental treatments, many patients would wind up with the right, but not the money, to try such regimens. Out of desperation, some would surely go into debilitating debt to try a drug that might harm rather than help them.

The current national program makes sure patients understand the risks of taking an experimental treatment and requires that the drug has been studied enough to know that the patient might possibly benefit from it.

Under the proposed new law, drugs that were only studied at a low dose on a small number of healthy volunteers could be sold to patients, and unethical doctors could receive kickbacks for persuading patients to try treatments that will not help them.

It’s easy to understand why every patient wants to have hope of a cure, and that’s the power of right-to-try laws.

So far, hype and false hope have convinced 33 states to pass right-to-try laws that provide no real advantage over the current national program. But rather than learning from the mistakes at the state level, patient activists and others are pushing Congress to pass a much more dangerous federal law.

In addition to encouraging the sale of unproven treatments at sky-high prices to desperate patients, the 2017 federal Right to Try Act would do the following:

  • Allow the sale of almost all experimental drugs, even those never tested on patients before.
  • Prevent patients and family members from suing the company if the treatment harms or even kills them.
  • Prohibit doctors and scientists from evaluating the benefit or harm of the experimental drugs.

Desperate patients are lobbying for the bill, but do they realize what they are lobbying for?

Instead of getting access to free experimental drugs that have some evidence of benefit and are being tested to help all patients, this law would allow naive and desperate patients to be exploited by greedy companies and unethical doctors.

The right-to-try movement opposes the FDA for what’s described as “interfering” with the doctor-patient relationship. They do not understand that unbiased scientific evidence is needed to help physicians and patients make informed decisions – whether to save a life or make a patient’s last months as enjoyable as possible.

Patients already have a right to try through the FDA’s humanitarian expanded access program, which gives them hope while protecting them from greedy exploitation. The proposed federal Right to Try Act would not.

Read the original article here.

Trump’s FDA Nominee Spurs Concerns About Drug Approvals, Off-Label Promotion

Bronwyn Mixter, Bloomberg BNA: March 14, 2017

President Donald Trump’s pick to head the FDA is spurring concerns about drug approvals and off-label promotion.

Trump March 10 nominated Scott Gottlieb to be the commissioner of the Food and Drug Administration. The nomination was widely praised by drug and device industry groups, but a consumer group and other stakeholders told Bloomberg BNA they are concerned that Gottlieb, who is a resident fellow at the American Enterprise Institute and previously worked at the agency as a deputy commissioner, has advocated for quicker drug approvals with less evidence and wants to loosen restrictions on off-label promotion of drugs and medical devices. Critics of the nomination also are concerned that Gottlieb is too closely tied to industry. […]

Gottlieb “is someone who is entangled in an incredible, unprecedented web of ties to industry spanning his professional career,” Public Citizen’s Carome told Bloomberg BNA.

Carome said Gottlieb has been both a venture capitalist and sat on the boards of several drug companies. Gottlieb also “accepted large amounts of money for the period 2012 to 2015, at least $400,000, in speaking fees and consulting fees from several companies and we think it’s just impossible for him to really fully disengage from those ties to industry,” Carome said.

“Like many of President Trump’s other nominees, Scott Gottlieb has extensive financial ties to the industries he’d be in charge of regulating and has shown more interest in reducing regulations rather than enforcing them,” Diana Zuckerman, president of the National Center for Health Research, told Bloomberg BNA in an email.

Zuckerman said “when FDA focuses too heavily on easing the burdens on industry, that shifts the burden to patients, consumers, and physicians” and “none of us can make informed decisions about medical treatments, diagnostics, or prevention strategies when the FDA doesn’t require clear scientific evidence and isn’t transparent about its decisions.”

“If he becomes Commissioner, I hope Dr. Gottlieb will enforce the law and focus on fulfilling the FDA’s essential public health mission,” Zuckerman said. “I expect that industry will strongly support Dr. Gottlieb’s nomination but divesting could potentially be complicated and therefore could delay his confirmation.” […]

Read the original article here.

What If Ryan Gets His Wish and Trumpcare Becomes Law

Shannon Firth, Washington Correspondent, MedPage Today: March 14, 2017

WASHINGTON — The Republican’s repeal and replace bill, American Health Care Act, cleared two congressional committees and the Congressional Budget Office released its scoring report, Speaker of the House Paul Ryan (R-Wisc) says passing the GOP plan is a make or break issue Congress.

So it is time to ask the pundits: what will happen if this bill becomes law?

MedPage Today asked policy experts on both sides of the great healthcare divide to answer that question and this is what they told us.

From the Pro Repeal and Replace Camp:

Douglas Holtz-Eakin, PhD, president of the American Action Forum touted the bill because it allows people to make their own choice. He predicts that eliminating the individual mandate will mean 5 million fewer uninsured in 2018.

“The bill basically says we respect your decision to not purchase insurance. There’s a public policy decision about how much we respect people’s decisions and clearly we know where the bill comes down on that,” he said. […]

And Now the Loyal Opposition:

Under the Affordable Care Act, the reason everyone pays for all of the various benefits was because doing so lowered costs, explained, Diana Zuckerman, PhD of the National Center for Health Research.

In the same way that car insurance lowers the cost of having an accident when everyone buys it, under this philosophy healthcare also protects everyone who buys it, Zuckerman said.

“Under [the AHCA] it’s a different view. It’s not that view of ‘We’re all in this together,’ and if we all share the cost, we’ll all get good insurance. Instead the view of this plan is every person for themselves. Everybody should get what seems best for them, even though that could result in 24 million not getting any insurance.” […]

Read the full article here.

Amid Flurry of New Cancer Drugs, How Many Offer Real Benefits?

Liz Szabo, Kaiser Health News: February 9, 2017

Marlene McCarthy’s breast cancer has grown relentlessly over the past seven years, spreading painfully through her bones and making it impossible to walk without a cane.

Although the 73-year-old knows there’s no cure for her disease, she wants researchers to do better. It’s been years, she said, since she has found a drug that has actually helped. McCarthy said she’s frustrated that the Food and Drug Administration is approving cancer drugs without proof that they cure patients or help them live longer.

Pushed by patient advocates who want earlier access to medications, the Food and Drug Administration has approved a flurry of oncology drugs in recent years, giving some people with cancer a renewed sense of hope and an array of expensive new options. A few of these drugs have been clear home runs, allowing patients with limited life expectancies to live for years.

Many more drugs, however, have offered patients only marginal benefits, with no evidence that they improve survival or quality of life, said Dr. Vinay Prasad, assistant professor of medicine at the Oregon Health and Sciences University, who has written extensively about the FDA’s approval process for cancer drugs.

Overall cancer survival has barely changed over the past decade. The 72 cancer therapies approved from 2002 to 2014 gave patients only 2.1 more months of life than older drugs, according to a study in JAMA Otolaryngology-Head & Neck Surgery.
And those are the successes.
Two-thirds of cancer drugs approved in the past two years have no evidence showing that they extend survival at all, Prasad said.
The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.
 
In a November study published in JAMA Internal Medicine, researcher Diana Zuckerman looked at 18 approved cancer drugs that didn’t help patients live longer. Only one had clear data showing that it improved patients’ lives, such as by relieving pain or fatigue.
Two drugs harmed quality of life. For example, thyroid cancer patients taking the most expensive drug, cabozantinib, scored worse on a scale measuring five symptoms: diarrhea, fatigue, sleep disturbance, distress, and difficult remembering, Zuckerman said. “We cannot have a system where drugs that may not even work are being sold for these amazingly crazy amounts of money,” said Zuckerman, president of the National Center for Health Research, a nonprofit in Washington that aims to explain research to consumers.
Recognizing the slow pace of progress, the American Society of Clinical Oncology has set goals for new cancer drugs of extending life or controlling tumors for at least 2.5 months. The bar was set relatively low because “it’s not very often that we come across a transformative treatment,” said Dr. Sham Mailankody, an assistant attending physician and myeloma specialist at Memorial Sloan Kettering.
Yet in a study published in September in JAMA Oncology, Mailankody found that only one in five cancer drugs approved from 2014 to 2016 met those standards.

The FDA wants to give patients the chance to benefit as soon as possible, rather than waiting for definitive proof of improved survival, Pazdur said. In some cases, the FDA requires pharmaceutical companies to perform long-term studies after drugs are approved, to measure whether drugs live up to their early promise.

But many of these studies never provide an answer, Zuckerman said. Once a drug is approved and is available to anyone, patients have no incentive to participate in a clinical trial. So studies can end with no clear conclusion.

Unless the FDA requires companies to provide survival data before approving a drug, “we may never have answers,” Zuckerman said. “We will have all of these expensive drugs on the market and we will never have the information we need about how well they work or even how safe they are.”

President Donald Trump has vowed to cut regulations at the FDA and recently told pharmaceutical industry leaders that he wants to further speed up the drug approval process.

Read the entire article here.

Can Breast Implants Cause Cancer? WJLA Investigates


“You have cancer — again.”

“What? Breast cancer?”

“No … a new one.”

So went the conversation between a stunned 40-year-old Raylene Hollrah and the plastic surgeon who performed her reconstructive surgery after she survived breast cancer seven years earlier.

Her new cancer diagnosis? Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL for short. Of all the potential side effects of breast implants, she did not recall her surgeon ever mentioning a small but increased risk of cancer.

“I did everything to keep cancer away,” Hollrah told 7 On Your Side. “Yet, I put a device in my body that caused cancer.”

The US Food and Drug Administration is not prepared to say that the textured breast implants Hollrah chose cause lymphoma, a cancer of the immune system.

But in 2011 and again in 2016, the FDA cautioned of a “possible association” between ALCL and implants.

“This has created a certain amount of anxiety and concern among the medical community,” said Dr. Mark Clemens of MD Anderson Cancer Center, one of the leading experts on ALCL in the world.

Clemens met Hollrah after her diagnosis, explanted her implants and asked her questions about what she was told and when. His research, and others of patients and surgeons, reveals that patients never think to ask about ALCL and only one-quarter of surgeons always discuss the risk with patients in the initial consultation.

“We would like surgeons to always discuss the small, rare, but potential risk of this serious disease,” said Clemens, who serves on the board of the American Society of Plastic Surgeons (ASPS) as the liaison to the FDA. ASPS urges its board-certified members to always talk to patients about the risks as part of the informed consent process.

When 7 On Your Side filed a Freedom of Information Request (FOIA) about ALCL cases reported to the FDA, we received more than 800 documents representing 441 cases, more than one-third unconfirmed, and at least 12 deaths. Even since the 2011 advisory from the FDA about ALCL and implants, when manufacturers responded to reported adverse events, they often listed many risks but didn’t include ALCL.

“They should. Absolutely,” said Madris Tomes, CEO of Device Events, and a former FDA analyst who managed the build of a new adverse event reporting system. Tomes looks for patterns of problems with medical devices, but spotty reporting makes pinning down exact numbers for ALCL tricky.

Whether silicone or saline, Song explained why patients choose textured implants. They have a more natural, teardrop look, thinner at the top, thicker at the bottom. Texturing is intended to keep them from rotating. Researchers are evaluating whether that texturing, or a bacteria, or genetics make a patient more vulnerable to developing lymphoma.

THE ANALYST: “We don’t know how common it is.”

7 On Your Side spoke with a leader in the field of women’s health, Diana Zuckerman, PhD, President of the National Center for Health Research. Zuckerman was our chief source for information about the risk of suicide after implants. Regarding BIA-ALCL, she wrote:

“It is not true that textured implants are the only ones associated with BIA-ALCL. This summary of a recent medical journal article clearly says that “most women with ALCL have at least one textured implant” but that doesn’t mean they all do.

Read the entire article here.

The above article was published in February 2017. In August 2014, the National Comprehensive Cancer Network (NCCN), a nonprofit alliance of leading cancer centers, provided guidelines for the diagnosis of “breast implant associated ALCL (BIA-ALCL), based on clear evidence that breast implants can cause ALCL.  In 2017, the World Health Organization (WHO) and the Food and Drug Administration (FDA) both issued statements confirming that breast implants can cause ALCL.  To read about the FDA’s 2017 report on breast implants and ALCL, click here (insert hyperlink to http://www.breastimplantinfo.org/implantalcl/)