Category Archives: We Are Quoted

Concerns That Public Hearings on Breast Implants Will Favor Implant Manufacturers

Kris Pickel, CBS News: October 4, 2018.


PHOENIX (3TV/CBS 5) — The Food and Drug Administration has agreed to hold a public hearing on Breast Implant Illness. It’s a victory for women who petitioned the FDA but CBS 5 is investigating concerns the hearings will be stacked to favor implant manufacturers.

Breast Implant Illness (BII) is not recognized as a medical condition.

It is a term used by thousands of women to describe a wide range of unexplained symptoms experienced by women who believe their implants made them sick.

Symptoms of Implant Illness

 

 

 

 

 

 

 

 

 

 

CBS 5 has been investigating BII for almost two years and has seen the number of women coming forward increase by the tens of thousands.

When our first investigation aired, the Facebook group Breast Implant Illness and Healing with Nicole, had 17,000 members. It now has more than 51,000.

News reports and social media are connecting women who believe they suffer from BII.

They are finding strength in numbers.

More than 21,000 women signed an online petition demanding the FDA hold public hearings.

The FDA agreed to meet privately with a small group of women who believe they suffer from BII.

Among the women who traveled to the District of Columbia for the September meeting at FDA headquarters were breast cancer survivors, women who believe implants made them sick, experts on breast implants and women who recently played a role in having the birth-control device Essure pulled off the market.

Women in the group say the FDA set the terms for the meeting: No cameras, no recording, no reporters allowed.

Following the September meeting, the FDA released a statementdisputing a study linking implants to illnesses.

Buried at the end of the statement, the FDA announced they would hold a public hearing on breast implants next year.

Nicole Daruda founded the website HealingBreastImplantIllness.com and the closed Facebook group Breast Implant Illness and Healing with Nicole.

Daruda say some of the issues they want to address include taking textured implants the FDA has said might be linked to the potential for a rare cancer off the market, comprehensive studies and requiring surgeons to give women a checklist of potential risks at least a week before surgery.

In the FDA’s public hearing, an advisory panel will hear from industry representatives, experts, women who believe their implants made them sick and members from the public.

Following the public hearing, that advisory panel will vote on recommendations to make to the FDA. The panel does not have the power to make changes. It will only make recommendations.

Dr. Diana Zuckerman on CBS News

Dr. Diana Zuckerman is president of the National Center for Health Research in D.C. and is responsible for a dozen Congressional investigations on a various health issues.

Zuckerman says in the past, the FDA has stacked the panels with plastic surgeons who have a financial interest in protecting breast implants. 

“Having surgeons whose entire livelihood, or almost entire livelihood, is based on breast surgery, with breast implants, can’t possibly be objective,” Zuckerman said.

She says she has witnessed multiple times where plastic surgeons advocate for implants and dominate the hearings.

“I’ve seen situations where a statistician, for example, says, ‘Look at how unsafe these products are,’ and the plastic surgeon says, ‘No. No. No. We put these in all the time and they are very safe.'”

We contacted the FDA a several times during this investigation and asked if they would be looking at the panel to eliminate possible conflicts of interest.

They responded with a link to their application for panel members, which includes a section that addresses conflict of interest.

Conflict of Interest

The FDA website lists the core group of eight voting members on the advisory panel.

CBS 5 was able to confirm at least two of the doctors perform breast implant surgeries and a regulatory expert who previously worked for Johnson & Johnson, which owns implant manufacturer Mentor.

Zuckerman says in the interest of ensuring an unbiased panel, people should contact their elected officials in Washington and ask them to  pressure the FDA to make sure no one with financial ties to the implant industry sits on the advisory panel.

One Woman’s Story

Robin Towt shares her story

Cancer survivor Robyn Towt was in the group of women who met with the FDA.

When diagnosed with breast cancer, Towt immediately opted for a double mastectomy.

She says her health issues, including anxiety and insomnia, started the day her implants were put in.

Having survived cancer before, radiation was not an option.

Towt chose not to do chemotherapy, leaving no explanation as to why she was getting sicker.

“I have been never been that miserable in my entire life and in that dark a place,” she said. “I feel horrible because my family suffered. My husband suffered. I was not a happy person. I was not a healthy person. I had no quality of life. I was desperate. I was sleep deprived.”

Towt says a friend in a cancer support group suggested she look into her implants as a source for her health problems.

After connecting with women on social media, Towt had her implants removed just four months after having them put in.

She says her symptoms disappeared within 48 hours.

CBS 5 Investigates has uncovered that while implant manufacturers are required to publish informational booklets that include warnings on potential risks of implants, plastic surgeons are not required to give the booklets to women.

Towt says after her implants were removed, she went back and asked her surgeon for the booklet so she could compare the warnings to the consent forms she signed.

Towt says the warnings in the booklet were stronger when it came to certain risks, including cancer associated with breast implants.

“I kind of felt duped when I was comparing them because if I had read the information in that booklet to start with, I would have never ever considered it,” she said.

Towt’s plastic surgeon did not return calls to CBS 5 inquiring when the booklets are provided to patients.

A date for the FDA’s public hearing has not been set.

The FDA says it will happen sometime in 2019.

 

Read the original article and watch the news segment here.

FDA Rarely Uses Its Power to Recall Dangerous Medical Devices. Why Not?

Meg Bryant, MedTech Dive: August 31, 2018.


The FDA has the authority to recall dangerous and risky medical devices, but it has rarely done so, largely relying on manufacturers to take necessary actions when a product defect or spike in serious adverse incidents occurs.

Since Congress passed the medical device amendments to the Food, Drug & Cosmetics Act in 1976, the agency has used its 518(e) mandatory recall authority just a handful of times. In 1991, the FDA ordered Medline to recall its Dynafeed enteral pump due to design flaws and failure to comply with good manufacturing practices. The agency issued three mandatory recall notices the following year and in 2008, recalled Nebion’s MRI device, citing lack of FDA approval and safety and effectiveness data, as well as noncompliance with GMPs.

There have been some recalls under federal consent orders, and the FDA has in four cases taken the unusual step of banning a medical device. The first time was in 1983 when it banned prosthetic hair fibers used to treat baldness because of serious risks including infections. Then in 2016, the agency simultaneously banned powdered surgeon gloves, powdered patient examination gloves and absorbable power used for lubricating surgeons’ gloves. The danger: Residue from the powder could be left behind in the body cavity, causing inflammation and scarring that could lead to complications later on. In addition, bits of latex from the gloves could bind the powder and be inhaled, putting people with latex allergies at risk.

Given Bayer’s recent decision to stop selling the Essure birth control device, following years of unmitigated safety concerns and mounting patient lawsuits, and the release of the Netflix documentary, The Bleeding Edge, many are questioning why the FDA seems so reluctant to wield its recall authority.

“The FDA has not taken them off the market, has not rescinded approval for specific uses, has not done a mandatory recall and has tried to put out [a] warning that the agency knows is not going to be effective,” said Diana Zuckerman, president of the National Center for Health Research. “They do that all the time.”

‘Insurmountable threshold’

“Once products are on the market, it’s almost an insurmountable threshold to get the agency to take action to pull them from the market,” said Michael Carome, director of Public Citizen’s Health Research Group. “In the case of [Bayer’s] Essure, had the company not voluntarily acted, I suspect FDA would not have pushed them to pull it from the market, based on statements they made over the last few years in the face of concerns.”

Approved in 2002, Essure was associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes and migration of the device into the pelvis or abdomen. The FDA required the addition of a boxed warning and patient decision checklist to the product’s labeling and in April restricted sales of Essure, but did not call for its withdrawal from the market.

That’s not unusual, says Jodi Scott, partner in Hogan Lovells’ Denver office and former FDA counsel. “By and large companies are pretty responsive to a very direct FDA request to take action,” she tol MedTech Dive. “And while I’m sure it doesn’t work in 100% of the cases, I will tell you it probably works 99% of the time.”

Mandatory recalls are also costly for FDA to take. According to the agency, the estimated annual reporting burden associated with section 518 actions is 1,098 hours.

As a last resort, FDA will order a recall, but it’s a lot easier to “look the company in the eye and tell them we think you need to do a recall and have them do it voluntarily,” Scott said. “And it happens much faster. To go to court and get an order takes a lot of time.”

It can also take time to sort out signals detected through the agency’s MDR reporting and Sentinel systems. If officials think there is an imminent risk of harm, they will do an analysis to determine whether the company needs to take some field action, which may or may not involve a recall. “You have to balance the risk and benefits,” Scott said, noting implants are often left in place and monitored when issues arise because of the risks associated with taking them out.

Still, she insists FDA “is not shy” about telling companies when reparative actions fall short and they need to do more. “But it’s all sort of informal, not invoking the mandatory recall authority,” she added.

Problem begins in premarket process

Critics say the real problem precedes FDA’s failure to act once a device is on the market and lies with the process used to bring most moderate and high-risk devices to market. Under the 510(k) premarket notification, companies need only to demonstrate that a device is substantially similar to another product in the market in terms of its intended uses and technological features. In most cases, no clinical trials are required.

Even when clinical trials are required for novel devices subject to premarket approval, they aren’t always randomized. And in cases where devices are given conditional approval and required to undergo postmark testing, the FDA is often lax about seeing that companies complete studies in a timely manner, they argue.

“They allow these studies to drag on for years and years and years, and by the time the studies are done, or if they are ever done, nobody needs the information anyway anymore because the product’s not on the market anymore or the product has changed so much that the information you have about the product that was being sold three years ago is not relevant to the product being sold today,” Zuckerman said.

Zuckerman pointed to the case of breast implants. The FDA approved two silicone gel-filled breast implants in 2006, with the proviso the manufacturers — Johnson & Johnson’s Mentor and Allergan — each would study 40,000 women for 10 years. Neither completed the studies, which involved cumbersome online questionnaires and did not provide any incentives for women to complete them. 

Too close to industry?

“Ultimately, the agency is too industry-friendly,” Carome told MedTech Dive. “They view the industry as a partner rather than a regulated entity.” He believes the adoption of user fees has made the situation worse by allowing industry to negotiate benchmarks for FDA product reviews and other activities in return for payments for reviewing product submissions and other services.

Meanwhile, a 2016 proposal to ban electrical stimulation devices intended to treat people with mental or behavioral disorder that who exhibit self-injurious or aggressive behavior has yet to be finalized.

At the time of the proposed ban, only one facility in the U.S. was using the devices: the Judge Rotenberg Educational Center in Canton, Massachusetts. “Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” William Maisel, chief scientist and deputy director science at CDRH, said at the time. “These devices are dangerous and a risk to the public health — and we believe they should not be used.”

No one is arguing the FDA should recall or ban every device that poses an imminent risk of harm, Zuckerman said. But in cases where FDA opts to keep a product on the market despite well-known risks, it should use the powers it has to require timely and well-designed studies that demonstrate safety and effectiveness versus available alternatives. The agency should “use the teeth it has,” she argued. […]

Read original article here.

The Human Tragedy of Poorly Regulated Medical Devices Gets the Spotlight in a Netflix Film

Amy Martyn, Consumer Affairs: July 27, 2018.


The motel where Ana Fuentes arrives one evening with her young daughters charges $110 for a single night and doesn’t offer weekly discounts. Fuentes asks the cashier for a moment so she can think about it.

Outside, the camera captures an anguished look on her face. It’s clear she can’t afford the expense. She books the room anyway. “Do you like it?” she asks her girls as they excitedly unpack their bags.

The family used to have an apartment, but Fuentes had to visit the emergency room so often that she lost her job, her daughters explain on camera.

Such situations aren’t rare in the United States, where experts have repeatedly warned that millions of Americans have almost nothing in savings and are a single medical disaster away from financial ruin. The problem is compounded nationwide by costly healthcare, lack of access to paid sick leave in the workforce, or a combination of the two.

But Fuentes’ story, like dozens of others featured in an upcoming expose about the medical device industry, has a particularly cruel twist. She says in the film that she was healthy until a doctor convinced her to undergo what was supposed to be a routine, non-surgical medical procedure — getting small birth control implants permanently embedded into her fallopian tubes.

The $155 billion medical device industry has mostly avoided the type of scrutiny that drug companies and health insurers sometimes face from elected officials and others. On Friday, a documentary about the device industry and patients like Fuentes called The Bleeding Edge is set to go live on Netflix, bringing what advocates hope will be widespread attention to an industry increasingly characterized by lax safety standards, enormous power in the operating room, and horrific side effects.

“If you’re going to have something implanted in your body for potentially the rest of your life, wouldn’t you like it to be really well-tested beforehand? Is that really too much to ask?” says Dr. Diana Zuckerman, a health policy analyst who has worked in the White House and as a staffer in Congress.

The current president of the National Center for Health Research, Zuckerman and the other researchers at her non-profit are among the few to have taken interest in faulty medical devices.  

Diving into the medical device industry

Hollywood directors Kirby Dick and Amy Ziering knew they wanted to make a documentary film about preventable medical injuries, Dick tells ConsumerAffairs, but that was about it.

Sitting in on one patient advocacy meeting for research, they caught a presentation that Zuckerman gave about the medical device industry and the ease with which questionable products get on the market. They decided that they had found their story.

The team interviewed approximately 70 patients to make their film, Dick tells ConsumerAffairs. The film also includes interviews with numerous whistleblowers, such as doctors, former Food and Drug Administration (FDA) researchers, and one medical device sales rep who requested anonymity in exchange for speaking on camera.

Dick and Ziering were previously nominated for an Oscar for The Hunting Ground, their documentary about sexual assault on college campuses. Another earlier film, The Invisible War, is an expose about sexual assault in the military.

But persuading people to speak out against the device industry made for the most challenging interviews they’ve done, Dick tells ConsumerAffairs. (A medical device industry lobbyist touts in one scene that the industry is more powerful than some national governments.)

The “E-sisters”

As the film and the research it is based on shows, the problem is bigger than any single device. The Bleeding Edge captures the story by focusing  on four implants — three of which were used exclusively women’s reproductive organs.

The narrative is driven forward by the story of the “E-sisters,” or the activists who say that they suffered debilitating side effects after receiving the permanent birth control implant Essure.

For years, the “E-sisters” have organized a grassroots campaign to convince regulators to ban Essure from doctors’ offices. That goal seemed like an uphill battle until last week, when Bayer suddenly released an announcement that Essure will no longer be sold in the United States by the end of the year.

Bayer frames the move as a “business decision.” The announcement came one week before the Netflix documentary was scheduled for release.

“I’m very glad that these issues are getting this kind of attention, and I hope that Bayer’s decision to take Essure off the market won’t take away from the bigger message of the film,” says Zuckerman, “which is the whole process for devices that makes no sense at all.”

“Why in the world would you want to have a regulatory agency in our government, the FDA, having much lower standards for devices than they do for prescription drugs?”

Essure implants

The story of Essure, in particular, only saw the light-of-day thanks to the “E-sisters,” who count 30,000 people in their Essure Problems Facebook group and have convinced numerous elected officials, doctors, and even early clinical trial participants to join their cause.

“One of the things that is disturbing to me is that these issues only came to light because of the work of victims,” former Representative Mike  Fitzpatrick (R-Pa.) said in an interview several years ago.

Women who agreed to participate in clinical trials for Essure in the late 90s have said that they there were sold on a pitch to get a free, non-hormonal, and permanent birth control that was already proven safe.

A nickel coil, the size of a ballpoint pen, would be placed in each fallopian tube. That was designed to create an inflammatory response so that the coils would become permanently encased in the resulting scar tissue.

Regulators with the FDA approved the device in 2002, despite admitting that they knew little about the long-term side effects of such a procedure, as footage that the E-sisters had obtained captures. What’s more, numerous clinical trial participants later said that their painful side effects were not included in the company’s official data.

Doctors not long after began using the devices without questioning potential risks. “For some reason we did that to women. And I did that, too,” Dr. Shawn Tassone, an Austin-based gynecologist, tells ConsumerAffairs.

Insurance and profit margins

The sales representatives who taught doctors how to place the devices — something that Bayer has defended as a common industry practice — offered no instructions on how the device should be removed if there were side effects.

“We were just told from the very beginning that even if they’re misplaced, you don’t have to remove them,” Tassone remembers.

The role that insurance coverage may have played isn’t examined specifically in The Bleeding Edge, but testimony from patients and doctors suggests that getting insurers to cover Essure proved much easier than getting them to cover removal.

Tassone remembers that both private plans and Medicaid paid fairly generously for the Essure procedure, especially considering that inserting Essure was much cheaper and less labor-intensive than tubal surgery, the older sterilization procedure.

“If you think about a tubal ligation where you go to the operating room, it’s $400 [in profit] give or take,” he say. “Essure in the office, after you subtract the amount of the device, it’s probably $1100.”

Treating any resulting side effects proved impossible for women navigating unfamiliar territory. Angie Firmalino, the New York City mail carrier who founded the E-sisters network, initially seeked help from a doctor who morcellated the coils into small pieces — sending the nickel elsewhere in her body.

Connecting patients with doctors who are willing and able to properly remove the devices, as well who are able to code it correctly so that insurance will pay, has since become one of the E-sister’s major tasks.

Tassone, for his part, implanted his last Essure device in 2013. He says it was a call from another doctor who convinced him not to perform the procedure anymore; a woman with Essure apparently had gotten pregnant, he was told, which can be extremely dangerous for both the baby and the mother. One researcher has counted 303 fetal deaths linked to the device.

Tassone has since switched sides, counseling the E-sisters online and in the operating room. He estimates that he has conducted 600 Essure removal surgeries.

Trust remains despite ban

In recent years, the advocates have convinced the FDA to add a black box warning to Essure. Later on, they were able to help pass a rule which requires doctors to give patients more detailed warnings about the product.

But that didn’t appear to stop most doctors from trusting the device. The American College of Obstetricians and Gynecologists continues to say on its website that lasting pain from the procedure is “rare.” By contrast, nearly 27,000 reports have been filed to the FDA’s “adverse event” report database describing health problems caused by Essure and 16,000 lawsuits have been filed here. An estimated 750,000 women worldwide have undergone the procedure.

Now that Essure is off the market, doctors may be more willing to attempt removal surgery, Tassone says, something he thinks is necessary but frightening

“They’re going to think its not a big deal to take out,” he worries. (More detailed advice about removal surgeries is offered on the Essure Problems page).

Generally, before any major surgery involving a permanent implant, researchers advise patients to press doctors on the specific devices that will be used. Zuckerman, the health policy analyst who helped inspire the Netflix film, recalls that even she struggled to get specific answers when she asked a doctor what brand of hip he would choose for her own surgery.

The procedure ultimately went well, she says, but trying to search for good data comparing brands beforehand was nearly impossible.

“In the vast majority of cases, the surgeons are still quoting the company data,” Zuckerman says. “The company’s data on humans is nonexistent —  at least publicly.”

Are Your Breast Implants Poisoning You?

Johane van den Berg, Longevity. June 18, 2018.

Victoria Beckham, Crystal Hefner, Pamela Anderson, Yolanda Hadid, Melissa Gilbert and Heather Morris. What do these famous women have in common with thousands of other women worldwide? Well, for one thing, they all decided to get breast implants when they were younger. And now all of them have decided to remove what many are referring to as their “toxic bags”.

After their arrival on the cosmetic-surgery market in the 1960s, both silicone and saline breast implants quickly became the most popular plastic surgery procedure for women. According to the American Society of Plastic Surgeons, breast augmentation is still the number one surgical procedure for women, ranking above liposuction, nose reshaping, eyelid surgery and the tummy tuck. The problem, explains Dr Diana Zuckerman, Ph.D. and President of the National Centre for Health Research in the United States, is that surgeons who administer breast implants often minimize the risks associated with this procedure. Consequently, the majority of women don’t realize that a few years after the procedure, they may need to have their implants removed. Additionally, they are unaware that removal costs at least as much as implantation. […]

Now, about 50 years after breast implants were first introduced globally, un-tracked numbers of women are complaining of a recognizable pattern of health problems, which they attribute to their implants. Those suffering from these symptoms generally refer to the condition as Breast Implant Illness or BII (although non-medical, this term is widely used). Various social media groups and organizations have been formed by these women, most notably Healing Breast Implant Illness and The Implant Truth Survivors.

Symptoms of this condition – which Dr Zuckerman explains, is a pattern of health problems likely caused by an autoimmune reaction to the implant – include mental confusion, joint pain, hair loss, dry eyes, chronic fatigue, and persistent flu-like symptoms. “In some cases,” she says, “silicone gel is leaking into their bodies and causing the autoimmune reaction. When the gel leaks into organs such as the lungs and liver, it can’t be removed surgically.”

In addition, a lot of women experience what is called capsular contracture. This occurs when the scar tissue around the implant (inside the body) gets tight and hard. This can make the breasts look abnormal and cause chronic pain and hardness.

Are there any forms of breast implants that are considered safe?

“There are no breast implants on the market that never cause side effects or complications,” says Dr Zuckerman. “In general, breast implants filled with saline are less likely to cause serious injury than those filled with silicone gel, but we know many women who have become ill because of saline implants.”

Often, when a woman chooses to undergo this procedure, she is persuaded by her plastic surgeon (or breast surgeons after mastectomy) that breast implants are safe devices. Although there are thousands of stories of women whose health deteriorated as a result of their implants, the voice a plastic surgeon will more than often outweigh the information. This is because patients tend to hear what they want instead of making a decision based on information from both sides.

“Then, when women experience these complications,” explains Dr Zuckerman, “they are furious at themselves for making a decision based on limited information and furious at their doctors for not warning them of the risks. The women who are most harmed by breast implants are the ones that don’t realize that their health is deteriorating because of their implants, or don’t have $8,000-10,000 to get their implants removed by an experienced explant surgeon.” […]

Read the original article here.

25 Reasons Not to Get Breast Implants

Dr. Nalini Chilkov, The Huffington Post: Dec 7, 2017

Last week the FDA reported that breast implants put women’s lives in danger. The big news last week was that a small number of women can get a very rare type of cancer (ALCL: anaplastic large cell lymphoma). It confirmed that death is a possible side effect of breast implants. […]

According to Diana Zuckerman, Ph.D., Elizabeth Nagelin-Anderson, M.A.
and Elizabeth Santoro, R.N., M.P.H.: In 2008, more than 300,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants, and almost 80,000 breast cancer patients had reconstruction after mastectomy, often with implants. The popularity of breast augmentation has more than tripled since 1997, when there were just over 101,000 of these procedures. More than 40,000 implant removal procedures were also reported in 2008. […]

In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture increases every year. Silicone-7 migrated outside of the breast capsule for 21 percent of the women, even though most women were unaware that this had happened.

Don’t forget the financial burden and increased health insurance costs that go with multiple surgeries and medical complications. In some cases the surgery to remove implants can be like a mastectomy, complete removal of the breast tissue and sometimes the muscle underneath.

Read the original article 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 original 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 original 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. […]

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. […]

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 original article here.

Can Having Breast Implants Lead to Suicide? 7 On Your Side Investigates

Kimberly Suiters, WJLA ABC7: November 7, 2016

Three-hundred thousand women will get breast implants this year, making it the number one cosmetic surgery in the U.S. Research shows the typical breast implant patient has high self-esteem and good mental health, higher and better than the general population. According to implant manufacturers, satisfaction rates top the 83-97 percentile range, excellent results for any kind of surgery. So why would some women with breast implants have a higher rate of suicide than women who don’t have them?

“Maybe just a coincidence,” Dr. Scott Spear, a well-known plastic surgeon in Washington, D.C., told 7 On Your Side. “There may be an association between breast implants and suicide, but it’s probably a loose association.”

That’s not the way Diana Zuckerman, PhD, president of the National Research Center for Women and Families, sees it. Not at all.

“When you look at suicide and implants, the women with breast implants are more likely to kill themselves.”

How much more likely? Anywhere from two to 12 times. Zuckerman wrote about that conclusion after evaluating seven studies on the topic.

“Some surgeons believe if a woman with implants kills herself, she must’ve had something wrong to begin with; that she got implants because of low self-esteem, depression, to feel better. But women with implants are more likely to kill themselves than with other (plastic) surgeries. Why would a mastectomy patient be 10 times as likely to kill herself as a mastectomy patient who doesn’t have implants?”

Zuckerman doesn’t know that answer definitively, but she is convinced there is something physiological or mental that causes women with implants to have a diminished view of themselves.

The number of women who get to that tragic point is small. According to the CDC: 9.8 women per 100,000 will commit suicide. And middle-aged women, in general, had the largest increase in suicide in the last 15 years, up 63 percent.

Dr. Zuckerman said women going through menopause are one of the highest risk groups. Their bodies have changed after giving birth, and they may be lured in by “Mommy Makeover” marketing.

“But according to research,” she said, “it’s a bad time. A dangerous time.”

[…]

Read the original article here.

11 Ways Your Breasts Can Change in Your 20s & 30s

Carolyn Steber, Bustle: July 5, 2016

Breasts can be both a blessing and a curse. And regardless of their size or shape, breasts can change in your 20s and 30s to the point where you may be left stunned, annoyed, or even worried. […]

2. They Will Probably Fluctuate In Size

Breasts can fluctuate in size for a seemingly unending list of reasons. […]

3. They Can Get Stretch Marks

As your breast size changes — due to weight gain, weight loss, or pregnancy — you may notice little lines starting to appear on your skin. These are stretch marks, and they can show up regardless of your age or skin color. […]

4. You May Find Lumps & Bumps

“Fibrocystic change, which is a very common condition characterized by benign lumps in one or both breasts, often emerges when women are in their 20s,” said Zahra Barnes, in an interview with Lisa Jacobs, M.D., on Women’s Health. You should get them checked out, but they are usually nothing to worry about. […]

6. Your Nipples May Protrude

Another post-pregnancy milestone to expect is larger nipples, as well as darker areolas. And these changes can end up being permanent. […]

10. One May Be Larger Than The Other

Most breasts aren’t the same size. The causes are numerous, from misaligned posture, to hormones, to pregnancy. Other times, it may be due to those underlying fibroids, according to Arpana M. Naik, MD, on HealthyWomen.org. […]

11. Your Boobs Become Something To Look After

If you find something concerning, make an appointment with your gynecologist, ASAP. Mammograms aren’t really something you need to think about until you’re 50, according to Diana Zuckerman, Ph.D. and Anna E. Mazzucco, Ph.D. on StopCancerFund.org. If you have a family history of breast cancer, however, those scans may need to start earlier. Talk with your doctor about what’s right for you.

For the most part, being in your 20s and 30s means having healthy, happy boobs. But if any of the above changes occur, do bring it up with your doctor. It’s better to get things checked out, then to assume everything is a-OK […]

Read the original article here.