Tag Archives: breast implant illness

Former ‘Bachelorette’ Clare Crawley Is Removing Her Breast Implants Over Health Concerns—Here’s What to Know

Korin Miller, Health: July 06, 2021


Clare Crawley is opening up about her decision to have her breast implants removed over concerns they’re impacting her health.

The Bachelorette star shared the news in a video posted to Instagram that she titled, “Coming to Terms.”

“I’m sharing this in hopes that it might help others going through something similar feel not so alone,” Crawley, 40, wrote in the caption. “I feel that this was important to share so I can be a resource for anyone going through this as well. I know how being your own health advocate is hard sometimes, and can feel like an uphill battle. This is the reality of life for so many people though! I’m just so incredibly thankful to all the people who are in my life that support me not only in my peaks but in the valleys as well.”

In the video, Crawley revealed that she’s been struggling with persistent medical issues over several years. “I’ve been going through things medically with my body that I have not had answers to, to be honest,” she said. “My skin has been having really bad hives and rash. My whole body is just inflamed and itchy.”

Crawley said that she’s also had “blood test after blood test” and seen several doctors. But test results didn’t give her answers about what is going on in her body.

After having two mammograms and an ultrasound—which revealed what she said were sacs of fluid behind her implants—she consulted with her doctor and decided to have her implants removed. “As much as I love my implants, my body is fighting them and recognizes it as something obviously foreign in my body,” she said, adding that blood tests showed an elevated white blood cell count over the past few years. “My body can’t heal. My body is in fight mode, constantly. It’s exhausting, it’s frustrating. It’s all making sense.”

While Crawley said that her decision isn’t the right one for everyone, it’s what’s best for her. “My health is the most important thing. They are coming out,” she said.

Crawley received messages of support in the comments, including from Kayla Lochte, wife of Olympic swimmer Ryan Lochte, who shared in March that she had her implants removed over health concerns—specifically she specifically cited as breast implant illness (BII). “Best of luck Clare! Get those toxic bags out,” she said.

While Crawley herself didn’t specifically say that she has BII, she implies it. Here’s what you need to know about the condition—and what to do if you think your breast implants may be impacting your health.

What is breast implant illness, exactly?

It’s important to get this out of the way upfront: Breast implant illness (again, BII) isn’t a medical diagnosis, and there are no hard numbers on how often BII happens.

[….]

That said, the US Food and Drug Administration (FDA) concluded last year that breast implants should have a “black box” warning to help women make “informed decisions” about potential risks associated with breast implants, including BII, which the FDA labels as “systemic symptoms.” It’s also important to note that BII is different from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma that can develop following breast implants, per the FDA.

BII is tricky to diagnose. “The symptoms women report are pretty nonspecific, and could be related to another illness,” Janie Grumley, MD, a breast surgical oncologist and director of the Margie Petersen Breast Center at Providence Saint John’s Center and associate professor of surgery at Saint John’s Cancer Institute in Santa Monica, Calif., tells Health. “It ends up being that, once we’ve worked out everything else and can’t figure out what’s going on, that’s when we think the issue may be breast implants.”

Research has suggested this is a real health concern. One July 2020 retrospective study published in the Annals of Plastic Surgery looked at 750 patients who had their breast implants removed by a surgeon over a two-year period. Researchers found that patients had “significant and sustained improvement” in 11 different symptoms after surgery. Patients found their symptoms improved within 30 days after having their implants removed.

Another study published in the same journal in January 2019, found that people with silicone breast implants had higher rates of the autoimmune conditions Sjogren syndrome, scleroderma, and rheumatoid arthritis than those who don’t have implants. They also had a higher risk of stillbirth and melanoma.

Why might breast implants make some people sick?

“All breast implants have a silicone shell that also contains various chemicals and small amounts of heavy metals,” Constance M. Chen, MD, a board-certified plastic surgeon and breast reconstruction specialist, tells Health. “Some breast implants also have a silicone filling that can leach off an intact implant or spill out of a ruptured implant. The silicone, chemicals, and/or heavy metals in the body can make some women sick.”

[….]

Scar tissue usually develops around the implant inside the body in an attempt to protect it from the “invader,” Diana Zuckerman, PhD, president of the National Center for Health Research who has researched breast implant safety, tells Health. “For some women, the scar tissue provides the protection they need, and they feel fine,” she says. “For other women, their bodies react more strongly, with an autoimmune reaction or other kind of reaction.”

What should you do if you suspect your implants might be causing your health issues?

You should talk to your doctor, Dr. Grumley says. Just know this, per Dr. Zuckerman: There’s no test that can tell if the implants are making you sick while they’re still in your body. But, she says, “if women find that they are developing symptoms that don’t go away, they should consider getting their implants and the scar capsule removed.”

It’s important to see a doctor who has experience in breast implant removal, Dr. Zuckerman says. Not only do they know what they’re doing, they’ll also know to remove the scar tissue that’s formed, which can contain silicone gel. If they don’t, “the chances of your health improving is not as good,” she explains.

[….]

To read the entire article, click here.

My breast implants are making me sick — and I’m not alone

Pamela Appea, Salon: June 20, 2021


In November 2016, a few weeks after I had breast implant surgery, I came down with an unexpected case of thrush (an unappealing fungal infection characterized by a thick white coating on my tongue). As a Black married mother of two, even though I was still sick, I tried — but failed — to power through and take care of my kids. With intense flu-like aches, pain, and fever, it hurt to eat, drink, swallow, or even open my mouth. I couldn’t properly brush my teeth for several days.

Unfortunately, my primary care physician was on vacation. Panicked, I called the Manhattan oncologist whom I had seen a few weeks earlier. He’d been very kind to me following my DCIS breast cancer diagnosis, unilateral mastectomy and post-surgical treatment. The officer’s medical team could barely understand me when I tried to make the appointment on the phone.

“I don’t think you have thrush — didn’t I just see you a few weeks ago?” he said, trying to put me at ease as I stared at his cheerful neon tie. (I think he prided himself on his fun ties.)

It was torture opening my mouth so the doctor could diagnose me.

“Okay, that’s the worst case of thrush I’ve seen in some time,” the seasoned specialist said. He said he was putting me on antibiotics stat. I asked — or rather, wrote on a notepad, since I couldn’t speak clearly — if there could be any connection between the my immune system and the very new breast implant that was now in my body. The oncologist emphatically dismissed the notion as impossible.

Once he got the results of my lab work back, my physician said there was no evidence of anything wrong; I should bounce back in a few days. “These things sometimes happen,” he told me, smiling as he ushered me out.

While the antibiotics eventually cleared up the thrush, unfortunately I have never fully bounced back. In subsequent years since my breast implants were put in, it became even more clear that something was going on with my immune system. But none of my doctors really listened.

Although it was not formerly recognized by the medical community until recently, Breast Implant Illness (BII) has, in the past few years, finally received attention from both media and researchers. Nicole Daruda founded a Facebook’s support group, called Breast Implant Illness Healing by Nicole, in 2013; now, it boasts over 145,000 members. Daruda tentatively estimates that 50,000 women in the US have BII, although precise research-backed numbers are not readily available

“We are overwhelmed by women trying to join the Facebook group to be educated about Breast Implant Illness,” Daruda said. She estimates that 3,000 to 5,000 women message the group’s moderators every month. To try to meet the demand, Daruda later founded a nonprofit, Healing Breast Implant Illness Society of North America.

Research is just barely starting to emerge on BII. One study, published in Annals of Plastic Surgery in 2020, followed 750 women suffering from Breast Implant Illness over a multi-year time period. Once these women surgically removed their breast implants, the vast majority reported the majority of their symptoms had significantly improved or disappeared entirely.

Awareness appears to be growing, too. A wave of celebrities are talking more openly about breast implants and their health and wellness — including Victoria Beckham, Ayesha Curry, Ashley Tisdale, Chrissy Teigen and others.

A documentary that touches on the subject of BII, “Explant,” is screening right now at the Tribeca Film Festival. The film follows Michelle Visage, one of the celebrity judges on “RuPaul’s Drag Race.” Visage, a media personality, singer, DJ and actor who was well known for her signature Double-D breasts, found that doctors didn’t take her seriously when she told the specialists her immune system was out of whack. Visage experienced chronic health issues, including Hashimoto’s disease, that she now attributes to her breast implants.

Awareness of BII is crucial given the popularity of breast implants. Since 1998, the number of breast augmentation procedures in the US has increased threefold; now, they are one of the most sought-out cosmetic procedures.

The desire for breast augmentation seems so powerful regardless of what else is going on in the world,” said Dr. Diana Zuckerman, founder of the National Center for Health Research. “What most concerns me is how reluctant most plastic surgeons have been to make sure their patients know the risks before making a decision.”

Because breast implant technology has existed for decades, many women erroneously believe they are safe.

[….]

In the years after my implant, some of my symptoms mirrored women on support groups I found online, which is how I figured out I had Breast Implant Illness. While symptoms sometimes waxed and waned, I got used to experiencing a host of autoimmune and other symptoms like insomnia, brain fog, extreme breathlessness, cuts that took weeks to heal, rashes, frequent colds and much more.

But BII is no longer regarded as a myth. Many or even most doctors, including plastic surgeon Dr. Anthony Youn, believe Breast Implant Illness is real. Dr. Youn acknowledges it is a controversial topic among many of his fellow American plastic surgeons.

“If you’re happy with your breast implants and you don’t believe they are adversely affecting your health, then there is no need for treatment. If you are sick and believe your implants may be the cause, speak with your primary care physician and a board-certified plastic surgeon about whether explantation may be a possible solution for you,” Dr Youn said. “There are many causes of the symptoms of Breast Implant Illness (BII) that don’t involve breast implants, so it’s often best to rule those out first,” he continued.

In his 17 years of practice in the metro Detroit region, Dr. Youn, a member of the American Society of Plastic Surgeons and The Aesthetic Society, has performed surgery on thousands of women who elected to get breast implants. Anecdotally, he estimates the number patients who later returned to his practice stating they had Breast Implant Illness symptoms is an extremely small percentage.

[….]

Though not all women with breast implants go on to develop Breast Implant Illness, all women deserve education, informed consent, insurance coverage and most important information about potential risks. If, in 2015, there had been an FDA Breast Implant Black Box Warning (which was officially unveiled in late 2020), I honestly never would have gotten breast implants in the first place.

To read the entire article, click here.

Patients Continue to Be Inadequately Informed of Risk for Breast Implant-Associated ALCL

Christina Bennet, MS, Cancer Therapy Advisor: February 8, 2021


Although the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been well-documented, patients considering breast implants continue to be inadequately informed of the propensity for disease development. Awareness of BIA-ALCL has risen since 2020, but adequate safeguards have not yet been put in place, according to experts in the field.

“There have been efforts made [to ensure patients are informed], but they have not been successful,” Diana Zuckerman, PhD, president of the National Center for Health Research (NCHR), said in an interview with Cancer Therapy Advisor.

The most recent effort to more frontally disclose the risk for BIA-ALCL is a final guidance document released by the FDA on September 28, 2020.1 The guidance, which applies to all breast implants, advised breast implant manufacturers to add a black box warning that mentions the risks associated with breast implants such as BIA-ALCL. In the guidance, the FDA also encouraged manufacturers to incorporate a patient decision checklist in the labeling to “better ensure certain information is received and understood by patients.”1,2 Manufacturers, however, are not required to follow these recommendations.

Zuckerman, who is a member of the Breast Implant Working Group, said she was surprised by the FDA’s decision to recommend rather than require these facets of the guidance. “We don’t have the answer to that question other than we have talked to FDA officials who said that at least some of this will at some point be a requirement, but we don’t know when that is,” she said.

With no mandates in place to ensure that patients receive information about the risks for BIA-ALCL—among other breast implant-associated complications—upfront, the industry is left to educate—and this does not seem to be working.

Patient advocates Terri McGregor and Jennifer Cook, both of whom have received a BIA-ALCL diagnosis, discussed a misleading patient brochure that has further contributed to the misinformation about breast implant-associated cancer risk. Sold online by the American Society of Plastic Surgeons (ASPS), the brochure featured the symbol for breast reconstruction awareness—a modified pink ribbon—and the slogan “Closing the loop on breast cancer.”3

The brochure was sponsored by several companies, including 2 prominent breast implant manufacturers, Allergan and Mentor. Though the document was promoted on Twitter by the ASPS and users were encouraged users to “stock up now” ahead of Breast Reconstruction Day,3,4  it notably made no mention of BIA-ALCL—not even on the page that describes the risks and safety issues associated with breast implants.

Conflicts of Interest Cloud Risk Disclosure

[…]

Eric Swanson, MD, a plastic surgeon at the Swanson Center for Cosmetic Surgery in Leawood, Kansas, told Cancer Therapy Advisor that plastic surgeons’ financial ties to breast implant manufacturers are part of the reason why they have been slow to respond to the issue of BIA-ALCL. “There’s a big problem with conflict of interest in plastic surgery. Once [a person has] taken funds from a company, it is very rare for the taker to be critical of that company,” Swanson said.

[….]

Zuckerman described the ASPS brochure as “terribly” out of date. “The Institute of Medicine report is more than 20 years old, and there has been a great deal of research since then,” she said.

[….]

The ASPS Brochure: Current Status

When Cancer Therapy Advisor inquired about the content of the brochure, an ASPS representative agreed that the information was “outdated” and removed the brochure from sale on its website.

Enclosed in the ASPS brochure was a list of websites that included breastimplantsafety.org, which—despites its domain name—did not include any safety information about breast implants. Instead, the domain redirected users to a different domain, smartbeautyguide.com, the patient site for The Aesthetic Society, a professional organization for plastic surgeons. A representative for The Aesthetic Society told Cancer Therapy Advisor that breastimplantsafety.org was active until 2015, when it migrated to their patient site, Smart Beauty Guide.

“We have been developing and will launch our new Aesthetic Society website that will include a dedicated section for patient education,” the representative wrote in an email. Within days of being contacted by Cancer Therapy Advisor, The Aesthetic Society updated the breastimplantsafety.org domain name to direct users to an existing page that provides resources about breast implants, including information about BIA-ALCL and breast implant illness, a systemic condition characterized by a wide range of symptoms that is currently under FDA investigation.18

Read the full article here

Study finds removing breast implants improved symptoms

Kris Pickel, AzFamily.com: October 1, 2020


PHOENIX (3TV/CBS 5) — A new study may be a game changer in the debate: Is breast implant illness real? Plastic surgeon Dr. Lu-Jean Fang designed the study involving 750 women with a diverse mix of breast implants, including silicone and saline, with shells that were either smooth or textured.

Every patient underwent a total capsulectomy. It’s a surgical procedure which removes the breast implant and all surrounding scar tissue, known as the capsules.

Prior to surgery to remove the implants, patients rated the severity of 11 symptoms commonly associated with breast implant illness, on a scale from 0 to 5.

Symptoms rated in study:

  • 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
  • difficulty breathing

Ten days after their implants were removed, the women rated their symptoms again and repeated the survey multiple times over the next year. The data was then analyzed by a team at Case Western University led by Dr. Corinne Wee and published in the Annals of Plastic Surgery.

After years of seeing her patients’ health improve following the removal of their breast implants, Dr. Feng says the results still came as a surprise. “I didn’t think it would be this good,” says Dr. Feng. When averaged out among the group, almost every symptom improved. Most symptoms drop to ratings considered ‘none’ or ‘mild’.

“For each one of these symptoms, there is a statistical difference so it’s not by chance anymore that they improve,” says Dr. Feng.

Researchers found health improvements happened quickly. If a woman saw improvements within the first ten days after surgery, the benefits were still present a year later. The most significant improvements happened in women who were obese or had some type of hardening of the scar tissue around the implant and who made lifestyle changes such as eating a healthy diet and exercise.

Removal of saline and silicone implants resulted in similar levels of improvements. The study notes “silicone is actually present in the shells of many saline implants.”

During years of investigations, numerous women have shared first-hand accounts with CBS 5 Investigates, saying when doctors failed to diagnose the cause of their symptoms, they were led to believe their symptoms were psychosomatic or the result of aging.

Dr. Feng says her study debunks the theory that breast implant illness is something women are imagining. “It is not in their heads,” says Dr. Feng. “This is my life’s work mainly because it’s such a simple solution. You take out the implant and all the surrounding scar tissue that houses the inflammatory reaction and the implant derived material, and the patient gets better.”

DIFFERENT THAN PREVIOUS STUDIES

For breast implants illness advocates, Dr. Feng’s study provides scientific evidence to back up claims made by tens of thousands of women.

Dr. Diana Zuckerman is President of the National Center for Health Research in Washington DC. An expert on national health policy, Dr. Zuckerman has worked for decades to get stronger warnings on the risks of breast implants. “This study absolutely confirms that there are women getting sick from their breast implants, and when their implants are taken out, they get well,” says Dr. Zuckerman.

In analyzing decades of previous studies, Dr. Zuckerman says major studies sponsored or conducted by breast implant manufacturers have a created a misleading perception surrounding the safety of implants.

Dr. Zuckerman says these studies have flaws, with the results often misrepresented. In some cases, she says, women were kicked out of studies if they got sick. She also points out it can take sometimes a decade or longer for symptoms to develop, which means studies end before some women start to experience problems.

As an example, Dr. Zuckerman cites the 10 year post-approval study by breast implant manufacturer Mentor on its MemoryGel CPG Breast Implants.

She says seven years into the study, 80% percent of the 41,000 women were no longer participating in the study.

Mentor provided CBS 5 Investigates with final data from its post-approval study showing that of  the 41,452 women enrolled in the study only 6,063 completed the study.

[…]

FDA RECOMMENDS NEW WARNINGS FOR BREAST IMPLANTS

On September 29, 2020 the FDA took their strongest steps to date to increase awareness on the risks of breast implants.

The agency is recommending labeling for breast implants include a box warning, the strongest warning by the FDA that a product carries the risk of serious injury or death.

While the FDA did not mandate manufactures include the warning, they recommended the following information be included: breast implants are not lifetime devices; are associated with the cancer of the immune system BIA-ALCL; patients have died from BIA-ALCL; patients have reported systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, auto immune disease; and that some patients recover from the symptoms after implants are removed.

The recommendations are carefully worded to acknowledge recovery from systemic symptoms may happen after implants are removed. However, the FDA stopped short of saying the implants cause the symptoms.

The FDA is also recommending a checklist for women to be given when considering breast implants.  The checklist would outline when implants should not be used; risks of implant surgery, cancer, systemic symptoms, rupture and complications; updated screening and follow up tests, implants are not lifetime devices and alternatives to implants.

The FDA says the labeling recommendations are intended to enhance but not replace discussions between patients and their physicians.

[….]

CDC SHUTS DOWN INSURANCE COVERAGE EFFORTS

Efforts to make breast implant illness an official diagnosis covered by insurance came to a sudden stop earlier this year.

Dr. Zuckerman was among the advocates invited to speak at the CDC’s March meeting on ICD-10 codes. The codes are used to diagnose medial conditions and show insurance companies why treatment is necessary. Without the codes, insurance companies will not cover the cost of treatment.

Dr. Zuckerman planned to attend the meeting and built a presentation. She says without explanation, she was notified the agency would not be exploring the option of ICD-10 codes for breast implant illness. “I was not given a reason why, other than it was considered too controversial,” says Dr. Zuckerman.

After months of requests to the CDC asking for an explanation as to why the topic was dropped from their agenda, the agency sent an email to CBS 5 Investigates stating, “There is no definitive evidence that breast implant cause the systemic symptoms.”

The agency also provided a list of ICD-10 codes providers can use for treatment and billing covering conditions ranging from breast deformity to atrophy.

However, the current ICD codes do not cover the symptoms commonly associated with breast implant illness such as fatigue, rash, joint pain and cognitive issues.

Efforts have not stopped to get ICD-10 codes for breast implant illness. Congressman Lloyd Doggett of Texas and Congresswoman Rosa DeLauro of Connecticut sent a letter to CDC Director Dr. Robert Redfield asking for clarification on why the topic was dropped.

Their letter references a growing body of research that thousands of women have been seriously harmed by breast implants and that “women continue to be denied health insurance coverage for medically necessary implant removal.”

Representatives Dogget and DeLauro point out women who elected to undergo breast implant surgery were “unaware of the potentially serious risks.”

[….]

The agency also provided a list of ICD-10 codes providers can use for treatment and billing covering conditions ranging from breast deformity to atrophy.

However, the current ICD codes do not cover the symptoms commonly associated with breast implant illness such as fatigue, rash, joint pain and cognitive issues.

Efforts have not stopped to get ICD-10 codes for breast implant illness. Congressman Lloyd Doggett of Texas and Congresswoman Rosa DeLauro of Connecticut sent a letter to CDC Director Dr. Robert Redfield asking for clarification on why the topic was dropped.

Their letter references a growing body of research that thousands of women have been seriously harmed by breast implants and that “women continue to be denied health insurance coverage for medically necessary implant removal.”

Representatives Dogget and DeLauro point out women who elected to undergo breast implant surgery were “unaware of the potentially serious risks.”

Read the full article here

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

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

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 Study Backs Breast Implant Illness Claims by Patients

Sasha Chavkin, International Consortium of Investigative Journalists: July 2, 2020


A new study in a leading plastic surgery journal offers more evidence to support the existence of breast implant illness, a malady reported by thousands of women but dismissed as scientifically unproven by many plastic surgeons and some health authorities.

The study focused on 750 women who complained of fatigue, memory loss, joint and muscle pain and other symptoms after having received breast implants. It found that as a group, the women experienced significant relief from their symptoms within 30 days of having their implants removed.

“The data speaks for itself,” said Dr. Lu-Jean Feng, a plastic surgeon and an author of the study. “It’s much more likely that the illness is due to breast implants if the improvements are within 30 days.”

The study adds to growing evidence that some women suffer systemic health problems after getting breast implants. It is well known that breast implants can lead to physical injuries such as rupture, leaking and painful tightening of scar tissue around the implant, known as capsular contracture. But many plastic surgeons have long contended that there is not enough scientific evidence to conclude that breast implants can cause health issues that affect the whole body, such as autoimmune disease and cognitive decline.

In 2018, the International Consortium of Investigative Journalists revealed that thousands of women around the world were suffering from serious illnesses after receiving breast implants as part of its Implant Files investigation.

Among the investigation’s findings were that an increasing number of studies indicated that breast implants were associated with systemic health effects such as autoimmune and connective tissue disease. These illnesses took a devastating toll on patients’ lives, often leaving them unable to work, struggling to maintain relationships and suffering severe pain.

The new study by Dr. Feng is not the first to show improvements in women’s health after they had their breast implants removed. But it has several notable elements: it has a relatively large sample size and it shows that major improvements occurred within 30 days of removal. In addition, all the patients were operated on by the same surgeon, Dr. Feng, using the same technique, eliminating the possibility that differences between doctors or methods influenced its results.

The women were surveyed before and after their breast implants were removed, and asked whether they suffered from 11 symptoms commonly associated with breast implant illness, including hair loss, joint pain, chronic fatigue and hives. Patients were asked to rate symptoms on a scale of zero to five. The mean preoperative score was 26.19; it dropped by nearly two thirds to 9.49, after removal.

The study was published in the Annals of Plastic Surgery, a peer-reviewed journal for plastic surgeons.

Diana Zuckerman, president of the health care policy think tank National Center for Health Research, said the publication was significant because it was a sign that the plastic surgery profession was beginning to accept the existence of breast implant illness.

“The plastic surgery journals have not been open to this kind of information,” Zuckerman said.

Breast implants are a crucial and lucrative product for plastic surgeons, and the breast implant business accounts for more than $1 billion in revenues each year.

The U.S. Food and Drug Administration has also shifted its stance on breast implant illness.

After long maintaining that there was insufficient evidence to connect breast implants and many symptoms reported by patients, the FDA now lists “Systemic symptoms Breast Implant Illness (BII)” among the risks and complications associated with breast implants, although it notes continuing scientific uncertainties.

“Symptoms such as fatigue, memory loss, rash, ‘brain fog,’ and joint pain may be associated with breast implants,” states the agency’s website.

Read the full article here

New Research Confirms Breast Implant Illness

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/