Tag Archives: breast implant removal

Patients Must Be Warned of Breast Implant Risks, F.D.A. Says

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Roni Caryn Rabin, The New York Times: October 27, 2021

Federal regulators on Wednesday placed so-called black box warnings on breast implant packaging and told manufacturers to sell the devices only to health providers who review the potential risks with patients before surgery.

Both the warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue.

Startlingly, the checklist identifies particular types of patients who are at higher risk for illness after breast implant surgery. The group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments.

That represents a large percentage of women who until now were encouraged to have breast reconstruction with implants following their treatment.

The Food and Drug Administration is also requiring manufacturers for the first time to disclose the ingredients used to make breast implants, information that patient advocates have long sought. The information must be made public in 30 days.

It is not clear how the new requirements will be enforced, and patients are highly unlikely to ever see a warning label on a packaged sterile medical device that is usually handled only by a surgeon. F.D.A. officials said in a statement that the patients “must be given the opportunity” to sign the checklist.

[….]

Reactions to the new requirements were mixed. While some doctors welcomed the new warning system, others worried that the potential risks and side effects would not be conveyed adequately by plastic surgeons who were eager to reassure patients the procedure is safe and that the new checklist would be handled in a dismissive manner.

Critics also said the checklist was overly long and written in obtuse language. “It’s better than nothing, but it’s not as good as it could be,” said Diana Zuckerman, a scientist who heads the National Center for Health Research and was a member of the working group that advised the F.D.A. on implant safety.

“They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by the implants,” Dr. Zuckerman said. “People understand it if you say, ‘Breast implants can cause lymphoma.’”

She worried that surgeons would not take the time to adequately review the information with patients.

“What if a surgeon says, ‘Here’s a checklist — I know it’s long, so it’s up to you if you want to read it or not’?” Dr. Zuckerman said. “Patient groups are very concerned that will happen.”

[….]

To read the entire article, click here.

First, Their Breast Implants Made Them Sick. Then They Were Hit with the Bill.

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Catherine Guthrie, Cosmopolitan: August 18, 2020.

Annie Reynoso wanted a tummy tuck. But her doctor said no. Uterine fibroids meant she wasn’t a good candidate for abdominal surgery. He had an idea though, the doctor. If what Annie was looking for was a physical boost, there were other options out there. Like breast implants.

[…]

Then it was a few years later, and odd things started happening: Her breasts swelled to a G-cup. She had fatigue that would knock her out for days. Sudden dizzy spells made it scary for her to drive. She’d get short of breath after walking just a few steps. She had night sweats that soaked her mattress. And there were even stranger symptoms: nausea if she ate before noon, and pain in her chest, neck, ears, and jaw that felt like the worst sunburn of her life. She kept tubes of Aspercreme in her purse, coat pockets, and desk drawer. At least a dozen times a day, she had to slather herself in ointment.

[…]

That’s when something finally changed: A friend of Annie’s started feeling better after her implants were removed, and a rheumatologist told Annie some of her symptoms aligned with Sjögren’s syndrome, an autoimmune disease potentially triggered by her implants. After that, all she could think about was getting them out.

Once again, she waited in a surgeon’s office. A new one this time. She’d gotten her implants in the Dominican Republic, where her family lives and they could help her through the recovery. Now she sat alone in New Jersey, consulting with a doctor about having her implants removed in a procedure called an explant. She was hopeful. Until she was told it would cost $7,500—and that insurance wasn’t likely to cover a dime.

[…]

And yet, there is evidence to suggest that breast implant illness might actually be an autoimmune disorder caused by implants. In 2018, a study in the International Journal of Epidemiology found that women with silicone breast implants had more than a 20 percent increased risk of being diagnosed with an autoimmune or rheumatic disorder.

There is also overwhelming anecdotal evidence online, in Facebook groups like Breast Implant Illness and Healing by Nicole, where hundreds of thousands of women share their stories. And of course, there are the endless comments on posts like Chrissy Teigen’s recent Instagram update about having her implants removed. Women saying they wish they could too—women saying, “Having them is making me sick.”

[…]

For sick women who are financially able to get explant surgery, it can change everything. In a July 2020 study in Annals of Plastic Surgery, researchers found that those experiencing symptoms of breast implant illness saw an improvement in their health within a month of having their implants removed. Like Lauren Dearman, who had explant surgery last November.

She was just 20 when her parents offered to pay $8,000 for her C-cup breast implants. Six years later, she began to have severe abdominal issues and chest pain, bad enough that she went to the ER. She was tired all the time and had such trouble focusing that she couldn’t even write a to-do list. She couldn’t climb the stairs to her third-floor apartment without gripping the railing. Her boyfriend told her she was out of shape. Her boyfriend, she knew, was wrong.

When she came across a Facebook group where women were talking about breast implant illness, the stories read like her own medical file. Within weeks, she made an appointment with a surgeon in Chicago who agreed that her implants could be at the root of her health issues. Lauren cried when she learned how much the surgery would cost. Her parents couldn’t pitch in financially this time, so Lauren withdrew $2,500 from savings and took out a personal loan for $6,500 so she could have the procedure. At $190 a month, she’ll be paying it off for the next three years. But she feels so much better now.

In a health care system that has no problem paying for Viagra (and Viagra overdoses), the fact that women like Lauren have to finance their medical care is infuriating, says Cari M. Schwartz, a lawyer at the firm Kantor & Kantor in California.

Schwartz is working on bringing a class-action lawsuit against insurance companies that deny explant coverage. She’s interviewed hundreds of women across the country desperate to get their implants out. In every case, insurers denied coverage, even when physicians deemed removals medically necessary. Schwartz has seen women rack up credit-card debt, borrow money, lose relationships and jobs, and go bankrupt in an effort to save their health. “Women are essentially told that their health issues are their fault,” she says, “because they chose to get implants.”

In 2019, the FDA said it was putting more effort into educating doctors and patients on the “systemic symptoms” many women with implants experience. Although they also still say they don’t have “definitive evidence demonstrating breast implants cause these symptoms.”

Doctors, too, remain reluctant to get onboard. “To recognize breast implant illness is to kill the goose that laid the golden egg,” says H. Jae Chun, MD, a Newport Beach, California, surgeon who specializes in explant surgery. “And many doctors just aren’t going to mess with the goose.”

In the meantime, one of the only options for desperate patients is the National Center for Health Research’s program to help women navigate the path to explant. They don’t give out money, but if a woman has health insurance, they’ll do what they can to coach her and her plastic surgeon through the insurance maze. Often, that means helping fill out paperwork explaining why the procedure is medically necessary. It’s a process that can take months and still results in a denial the majority of the time, says Diana Zuckerman, PhD, the group’s president. But so far, they’ve helped more than 1,500 women get the explants they need.

[…]

Read the full article here

The Number Of Women Having Their Breast Implants Removed Is on the Rise

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Kristin Canning, Women’s Health: August 8, 2020

Something weird was going on with Laura Miranda’s left breast; the shape was changing. Two days prior to her noticing that something looked off, she’d had her first mammogram (breast cancer runs in her family, so she’s vigilant about getting the necessary tests). Now, her left breast seemed to be “deflated,” as she describes. It was June of 2016.

She’d gotten implants on a whim at 22 to fulfill the big-busted aesthetic ideal at the time. They were offered to her as a gift by the gym she worked for early in her career as a trainer—the athletic club had a partnership with a plastic surgery group, and she was meant to be a sort of walking advertisement for them.

She suspected the pressure from the x-ray machine had caused a leak in one of the implants since she’d previously read that mammogram techs have to use less force when implants are involved. “I thought, ‘that sucks,’ but figured they were 16 years old, and that’s just part of the game,” says Miranda, who is also now a doctor of physical therapy in New York City.

She could deal with a little asymmetry on her chest. What was unbearable were the symptoms to come.

Miranda started experiencing days-long bouts of fatigue and body aches a few weeks later. “I was launching a business and working crazy hours, so I attributed my symptoms to that,” she says. “I didn’t think to see a doctor.”

But she kept feeling worse. Eventually, she was bedridden every few days. “In 2017, I was dealing with intense brain fog and cognitive decline, writing and concentrating for my work was nearly impossible, I had to nap between every client I trained, and my vision was shaky,” says Miranda. “I was so tired that I couldn’t work out, so I gained weight and my mental health was in a really bad place.”

She visited her GP, then a cardiologist, endocrinologist, and holistic health practitioner. She had high blood pressure, but other than that, all her tests came back normal. Around the same time, her sister sent her a social media post from a model who talked about how her implants had made her sick. “I knew deep down that this was probably what was going on with me,” Miranda says.

Googling led her to a Facebook group called Breast Implant Illness and Healing by Nicole, a page started in 2016 by Nicole Daruda, who had her implants surgically removed in 2013 after suffering for years from symptoms much like Miranda’s, which she believed were linked to the devices in her chest. The procedure is known as explantation, or explant surgery, and involves the removal of both the implants as well as the scar tissue capsules surrounding them.

“I had never heard of breast implant illness, and no doctor ever mentioned it to me,” Miranda says. “But seeing all these women with such similar symptoms, who also had implants, made me realize something was going on here.”

She immediately wanted to get hers removed. “It just made sense.”

[…]

The thing is, BII isn’t really new—it’s just finally getting public attention. “Women have been complaining of issues with their implants since the 90s—but social media has allowed them to connect to amplify their voices and concerns,” says Diana Zuckerman, PhD, president of the National Center for Health Research, and its Cancer Prevention and Treatment Fund.

Jade Root, a U.S. Army major and fitness competitor, also found out she was suffering with BII thanks to the BII social media community. She’d gotten implants on the recommendation of her fitness coach seven years ago to make her body appear more proportional and up her chances of success on the stage. She slowly started to develop the classic symptoms often attributed to BII. “I chalked it up to motherhood and my deployment. I was managing a lot,” Root says.

But during a break from bikini competitions, her symptoms became crippling. “I couldn’t recall basic terms I needed to use at work every day, I couldn’t complete the drive to the office without nearly falling asleep, even after getting seven hours of sleep the night before.” Doctors prescribed her two meds for joint pain and numbness and one for sleep, and they attributed her memory loss to anxiety, for which she was prescribed Xanax. “It felt like I was forcing myself to get through every day. I couldn’t live like that.”

[…]

Unfortunately, BII “isn’t a disease we can test for,” says Dr. Alan Matarasso. Determining whether someone is dealing with BII is more a process of elimination of other possible causes. “It’s a constellation of symptoms that can potentially be linked to many conditions,” he explains. “And we know that breast implants are one of the most common and thoroughly studied medical devices on the market, and again, the mass majority of people who have them are happy with them and don’t develop any health problems.”

[….]

Still, new research is pointing to the fact that hundreds of thousands of women aren’t exactly making this up. A study published just last month in The Annals Of Plastic Surgery followed 750 women who had explant surgery in 2017 and 2018, tracking the most commonly reported symptoms of BII (the 11 listed above) before explantation, then from 1 to 1,000 days post-op. The study showed significant improvement in all 11 symptoms immediately following explant surgery, and the improvements were maintained long term. Those results echo the findings of several smaller studies that showed patients who suffered from this type of sickness got better after having their implants taken out.

[….]

Chelsea Harrison, a yoga instructor and former bikini competitor, had to do the same. She got breast augmentation when she was 23. “In one of my first bikini competitions I placed third, and the women in first and second both had implants. I was super self-conscious about it,” she says. A few years later, she started to notice rashes, fatigue, and anxiety, but didn’t link the issues to her implants.

Eventually, she had problems with what’s called capsular contracture, where the scar tissue around the implant hardens and can cause pain. “The first surgeon I visited told me I ‘didn’t want to take my implants out from an aesthetic standpoint,’” Harrison remembers. (It can be surprisingly difficult to find a surgeon willing to do explantation, says Zuckerman, because docs are afraid patients will be displeased with the results. And of course, there are risks with any surgery.)

[….]

In the summer of 2019, the Breast Implant Working Group (which includes Dr. Matarasso and Zuckerman) submitted a proposed black box warning for implant manufacturer websites (like what you might find on a box of cigarettes) and a patient checklist to the FDA for consideration. The checklist is meant to be given to patients who are considering implants for their sign-off, and includes detailed information on the potential health risks associated with them.

“We hear that patients just aren’t getting this information from their doctors, or if they do, it’s a huge 40-to-100-page booklet that’s difficult to read and understand,” says Zuckerman. The FDA then released their own proposed warning and checklist in October 2019 (You can find it starting on page 12 of this document.)

But Zuckerman says that the FDA versions of these warnings use “much weaker” language. “The [Breast Implant Working Group] doesn’t feel like it’s enough, so we sent our criticism along with a petition with over 80,000 signatures to support our black box warning and checklist language.” [….]

The hesitation to adopt strong language around BII may be because several studies have not confirmed the link between breast implants and BII. But, Zuckerman argues, “A lot of these studies that were done in response to early claims from women that their implants were making them sick were funded by manufacturing companies or plastic surgeons, and most did not include enough women who had implants for many years,” she says. “Plastic surgery is big bucks, and it could be less profitable if women are concerned they’ll be harmed; that’s why even doctors who believe in BII have been afraid to speak up about it because they could be ostracized by their colleagues.”

But the tides are changing…somewhat. The ASPS, which is the largest plastic surgeon society in the world, has endorsed the Breast Implant Working Group’s patient checklist and likely will endorse the black box warning with a few proposed tweaks, says Zuckerman. She hopes the FDA will adopt the warning and checklist soon.

[….]

Read the full article here

New Research Confirms Breast Implant Illness

How Safe Are They?, Summaries of Implant Studies by Other Researchers, ,

Diana Zuckerman, Ph.D.

The biggest controversy regarding breast implants is whether and how often women with implants become sick with a pattern of symptoms that are known as breast implant illness. A study published in Annals of Plastic Surgery in July 2020 provides clear evidence that most women with these symptoms will recover dramatically if their implants and scar capsules are carefully removed by an experienced explant surgeon.

The study by Dr. Corinne Wee and her colleagues at University Hospitals Cleveland Medical Center compares 11 common breast implant illness symptoms of 750 women whose implants were explanted and not replaced in 2017 or 2018 1. Patients were asked to rate the 11 symptoms on a six-point scale (0-5, with 5 indicating “very severe”) at three times: prior to surgery, within 30 days after surgery, and during the following year.  The symptoms included: numbness and tingling in the extremities; joint and/or muscle pain; hair loss; memory loss/cognitive problems; dry eyes and/or blurred vision; chronic fatigue; breast pain; rashes and/or hives; food sensitivity/intolerance; flu-like symptoms and/or low-grade fever; and difficulty breathing.  The average age of the implant at the time of explant was 12.6 years, and approximately half the women had saline implants and half had silicone gel implants.  Possible total scores for rating the symptoms ranged from 0 to 66; the average score prior to explant was 26.2 and within 30 days after explant was 9.5, which was a highly statistically significant improvement (p < .0001, which means that there is less than one chance in 10,000 that the improvement occurred by chance).  Although average scores on each of the 11 symptoms ranged from a low of 1.4 (for rashes and for flu) to a high of 3.5 (fatigue), each of the 11 symptoms also showed significant improvement at the .0001 level within 30 days.  When asked to rate their symptoms during the year after Day 30 (at a median of 138 days), the women’s improvement in symptoms was maintained but there was no additional improvement.

This study confirms similar results of a smaller study by De Boer and his colleagues published in 2016, which reviews and combines data from 23 studies, cases series, and case reports available at that time about the results of explanting breast implants “in patients with silicone-related complaints and/or autoimmune disease2.” These complaints (symptoms) included fatigue, myalgia, dry eyes, and memory and concentration disturbances.  Based on the research, the scientists calculated that 75% of the patients (469 of 622) had substantially improved symptoms when their implants were removed. However, the results were less promising for autoimmune diseases (such as Raynaud’s, IBS, and allergies); diseases improved only if the patients also received immunosuppressive therapy in addition to the explant surgery.

It also confirms our own research at the National Center for Health Research, not yet published, that shows dramatic improvement on these symptoms in a study of more than 300 women who had their implants removed.

It is important to know that almost 20 years ago, several studies conducted by government funded scientists were published in the scientific and medical literature indicating a statistically significant association with several connective tissue or autoimmune diseases or symptoms. Replication is the key to science; scientific literature usually builds on previous findings, or explains how they differ.  However, the studies that indicated possible risks of breast implants were generally ignored and eventually outnumbered by dozens of articles funded by implant companies or plastic surgeons, or both. None of the studies or either side of the controversy were focused on breast implants made by Mentor or any other specified company.

References

  1. Wee, C.E. Annals of Plastic Surgery: July 2020 – Volume 85 – Issue S1 – p S82-S86 https://journals.lww.com/annalsplasticsurgery/toc/2020/07001
  2. De Boer M, Colaris M, van der Hulst RR, Cohen Tervaert JW (2017) Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research 65(1):25-36. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406477/

Can Breast Implants Cause Cancer? WJLA Investigates

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Kimberly Suiters, ABC7 WJLA: February 6, 2017.

“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.