Category Archives: We Are Quoted

Congressman calls for FDA to continue vaccine trials

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D’Andre Henderson, ABC News: December 29, 2020.

WASHINGTON, D.C. (WRIC) — Americans are hopeful that the COVID-19 vaccines will make 2021 a better year than 2020. However, there are concerns that Pfizer and Moderna will stop their clinical trials and immediately treat everyone in their placebo group.

Some scientists, doctors and now a Congressman argues that can be dangerous because they said there is still so much unknown about the vaccines.

Rep. Llyod Doggett of Texas wrote a letter to the Food and Drug Administration (FDA) urging for the clinical trials to continue.

“the continuation of clinical trials is critical to our understanding of the efficacy and length of immunity the vaccines offer,” Doggett wrote.

In the letter, Doggett said while the initial results received from Pfizer and Moderna are showing positive results, it’s not definitive given the limited data.

[…]

“Clinical trials have suffered from a lack of diverse participant enrollment and evaluation of subpopulations,” Doggett said. “Including individuals with comorbidities, children, pregnant and breastfeeding patients, long-term care residents and individuals with diverse racial and ethnic backgrounds.”

Diana Zuckerman, President of the National Center for Health Research, a non-partisan think tank in Washington D.C., agrees that the clinical trials should continue. She said healthcare workers who volunteered for the clinical trials should have immediate access to the vaccine if they want it.

“Like most public health experts, I’ve been very concerned that Pfizer and Moderna told the FDA that they want to stop their clinical trials of the COVID vaccine and instead immediately inoculate everyone in their placebo groups,” Zuckerman said. “While I understand the desire to reward the clinical trial volunteers for their service, it would be a huge loss of information from a public health point of view. Losing the placebo group means we’d have no way to scientifically determine which of the vaccines – if any — have 95% efficacy rates that last more than 2 or 3 months. Or how long the vaccine works on people over 75.”

Zuckerman added the people who volunteer for the clinical trials shouldn’t be vaccinated before those in priority groups such as teachers, essential workers, etc.

“Since many of the study volunteers are young and healthy, it also seems unfair for them to “cut in line” for a vaccine while healthcare workers and others at high risk are still waiting their turn,” she said.

[…]

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Covid-19: Should vaccine trials be unblinded?

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Jeanne Lenzer, BMJ: December 29, 2020.

The lack of planning for how to treat participants in covid-19 vaccine trials is a bad precedent, with the loss of potentially valuable safety and efficacy data, say research experts. Jeanne Lenzer reports:

 

In October the US Food and Drug Administration issued non-binding guidance to manufacturers of covid-19 vaccines urging them to devise a method to allow volunteers in their studies’ placebo arms to receive the vaccine while also maintaining the integrity of ongoing scientific data collection.1 Emergency use authorisation was not “grounds for stopping blinded follow-up,” said the agency.23

The companies say they have an ethical obligation to unblind volunteers so they can receive the vaccine. But some experts are concerned about a “disastrous” loss of critical information if volunteers on a trial’s placebo arm are unblinded.45

To try to tackle the problem the FDA invited Steven Goodman, associate dean of clinical and translational research at Stanford University, for a recommendation that could balance the right of volunteers to find out whether they were in the placebo arm and the simultaneous need to preserve scientific data.

Goodman recommended a study design endorsed by Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases: a blinded crossover study in which placebo recipients would be given the vaccine, and vice versa.235 That would ensure that all volunteers receive the vaccine but would be unaware of which shot they received at which time. This would allow ongoing surveillance of safety issues and more time to observe any waning effects of the vaccine and the possible need for booster doses.

But the companies said that the demands of a blinded crossover design were “onerous” and might not be feasible.6 And even before the FDA advisory committee meeting on Moderna’s vaccine on 17 December, the company notified volunteers that they could learn their status if they chose to receive the vaccine.

Pfizer also sent a letter to its trial participants one week after its vaccine was authorised on 10 December.7 It told them that, on request, they could learn whether they were in the placebo arm so they could receive the vaccine as it became available and according to recommendations of the US Centers for Disease Control and Prevention.

Asked by The BMJ whether the FDA had set any baseline requirements for the companies regarding the removal of blinding, the agency declined to answer, referring the journal to the respective companies for their plans.

Pfizer told The BMJ that the “move from the placebo group to the vaccine group would be completely optional, and participants would be encouraged to remain blinded throughout the full study duration.” Moderna failed to respond to several requests for comment.

Loss of data

Diana Zuckerman, president of the National Center for Health Research, told The BMJ that the FDA could have demanded that companies use the blinded crossover design for them to win full approval for their vaccines. She said that failure to do that meant the loss of future reliable data, which is especially concerning given that preliminary data are insufficient to determine efficacy.

“I’m especially concerned that Pfizer’s vaccine trials included only five people aged 75 and older who were diagnosed with covid-19, with an unspecified number of those defined by Pfizer as severe cases,” she said. “That makes it impossible to determine how effective the vaccine is for frail elderly patients.”

Although the FDA has granted the vaccines emergency use authorisation, to get full licence approval two years of follow-up data are needed. The data are now likely to be scanty and less reliable given that the trials are effectively being unblinded.

Consumer representative Sheldon Toubman, a lawyer and FDA advisory panel member, said that Pfizer and BioNTech had not proved that their vaccine prevents severe covid-19. “The FDA says all we can do is suggest protection from severe covid disease; we need to know that it does that,” he said.

He countered claims, based on experience with other vaccines, six weeks of follow-up was long enough to detect safety signals. Six weeks may not be long enough for this entirely new type of “untested” [mRNA] vaccine, Toubman said.

Goodman wants all companies to be held to the same standard and says they should not be allowed to make up their own rules about unblinding. He told The BMJ that, while he was “very optimistic” about the vaccines, “blowing up the trials” by allowing unblinding “will set a de facto standard for all vaccine trials to come.” And that, he said, “is dangerous.”

Footnotes

  • Correction: On 30 December we amended the final paragraph to clarify Steven Goodman’s comment.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

References

  1. ? Food and Drug Administration. Emergency use authorization for vaccines to prevent covid-19: guidance for industry. 2020. https://www.fda.gov/media/142749/download.
  2. ? Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee meeting December 10, 2020. 2020. https://www.fda.gov/media/144245/download.
  3. ? Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee December 17, 2020 meeting briefing document. 2020 https://www.fda.gov/media/144434/download.
  4. ? WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation. Placebo-controlled trials of covid-19 vaccines—why we still need them. N Engl J Med2020. doi:10.1056/NEJMp2033538.
  5. ? Weiland CZ. Noah. Many trial volunteers got placebo vaccines. Do they now deserve the real ones? New York Times. 2 Dec 2020. https://www.nytimes.com/2020/12/02/health/covid-vaccine-placebo-group.html.
  6. ? Karlin-Smith S. Covid-19 vaccine sponsors want US FDA to find alternatives for control-arm data after first EUA. Pink Sheet. 2020. https://pink.pharmaintelligence.informa.com/PS143143/COVID-19-Vaccine-Sponsors-Want-US-FDA-To-Find-Alternatives-For-Control-Arm-Data-After-First-EUA.
  7. ? Tanne JH. Covid-19: FDA panel votes to approve Pfizer BioNTech vaccine. BMJ2020;371:m4799.  doi:10.1136/bmj.m4799 pmid:33310748 FREE Full TextGoogle Scholar 

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FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine

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Noel King and Sydney Lupkin, NPR: October 22, 2020

NOEL KING, HOST:

There are several COVID-19 vaccines in development. But before they are approved, they have to be safe. It’s the FDA’s job to ensure that. Today an FDA advisory panel is meeting for the first time about the coronavirus vaccine. It’ll be making recommendations based not on politically motivated timetables, but on data.

Sydney Lupkin covers the pharmaceutical industry for NPR. Good morning, Sydney.

SYDNEY LUPKIN, BYLINE: Good morning.

KING: So what is the deal with this FDA panel? Who’s on it? What are they going to be doing?

LUPKIN: Well, the FDA regularly turns to committees of outside advisers for guidance. Most often, these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today’s meeting of the committee that looks at vaccines is going to be a little different.

KING: How?

LUPKIN: Like everything else in this pandemic, it’s a bit unusual. The big difference is that the committee isn’t going to be sifting through data for a specific coronavirus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children’s Hospital of Philadelphia.

PAUL OFFIT: How robust should safety data be? How long, for example, after the first or second dose should patients be followed or participants be followed for any possible safety issue?

LUPKIN: They’ll be discussing FDA’s existing guidance to companies, which includes some of that information. They’ll also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA usually heeds the advice of these committees, but it doesn’t have to.

KING: So since there’s no vaccine to review, I would think that in ordinary times, we would not know about this meeting. It would not be news at all. It’s very clear that the FDA wants to make public that this is happening. Why do they want to do that?

LUPKIN: Well, I mean, it gives the American public a window into the process. There’s been so much discussion around whether the FDA will put politics ahead of science. So it’s important to see what’s going on. And the FDA has questions that it wants answers to. Here’s Dr. Miles Braun, a former FDA epidemiologist.

MILES BRAUN: There is a level of humility that the FDA is coming to its advisers with. And I think that’s a good thing. And if they find out they’ve missed some important things, they’ll address those.

LUPKIN: Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in. Diana Zuckerman is the president of the National Center for Health Research, an advocacy group slated to speak.

DIANA ZUCKERMAN: We’ve seen the guidance of what they’re telling companies they’re supposed to be studying. Frankly, they’re not very stringent, so we are concerned about them.

LUPKIN: She hopes the meeting will delve into making sure the clinical trials are diverse, for example. She also questions whether the study approach the FDA suggested to manufacturers is long enough to assess vaccine safety.

[…]

Read or listen to the full article here. 

Study finds removing breast implants improved symptoms

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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.”

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FDA Updates Breast Implant Labeling Recommendations to Help Inform Patients About Dangerous Potential Side Effects

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Beth Fand Incollingo, Cure: September 29, 2020

Makers of breast implants should supplement their labeling to include a boxed warning about health problems that can arise from the devices, along with a patient decision checklist that highlights those concerns, according to final guidance issued today by the Food and Drug Administration.

The guidance, titled “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication,” recommends, but does not mandate, that manufacturers include information about two major health issues that can arise from implant use: breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII), an autoimmune condition that can result in brain fog, fatigue, rash, and muscle or joint pain. A draft of the document was issued in 2019.

[…]

Roxane Vermeland, a breast cancer survivor who was treated for BIA-ALCL after receiving implants as part of breast reconstruction after mastectomy, was pleased to hear about the FDA’s decision.

“This is great news,” she said in a statement to CURE®. “We have been advocating hard for this, as women need to know the risks of implants up front so they can make an informed decision. The black-box warning alone is a major accomplishment for us which will truly make women think about the decision to put implants into their bodies. I am in tears as I write this.”

Guidance details

According to the guidance, the boxed warning should state that breast implants are not considered lifetime devices; the chance of developing complications increases over time; some complications will require more surgery; implants, particularly textured ones, have been associated with the development of BIA-ALCL; and implants have been associated with systemic symptoms. The checklist should note situations in which the device should not be used; considerations for a successful breast implant candidate; risks associated with surgery and BIA-ALCL; the importance of appropriate physician education, training and experience; the risk of BII; and should suggest discussion of options other than breast implants, the guidance states.

The guidance also suggests updates to the silicone gel-filled breast implant rupture screening recommendations, stating when MRIs should be conducted; inclusion of an easy-to-find description of the materials used to make the implants; and provision of patient device cards that will inform patients about what kind of implants they have, state a serial or lot number for the specific devices and include a toll-free phone number for the manufacturer.

The labeling recommendations are intended to enhance, but not replace, discussions between doctors and patients about the benefits and risks of breast implants, the FDA wrote in a press release.

Finally, the FDA has updated its guidance titled “Saline, Silicone Gel, and Alternative Breast Implants” to make it consistent with the new labeling recommendations. The FDA stated that it will continue to work with professional medical societies, patient advocacy groups and women’s health organizations to help ensure that risk information about breast implants is disseminated to patients.

“As new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions,” Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in the release. “After working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in an easy-to-understand way. It is important that patients discuss the risks and benefits of breast implants with their health care provider, and we hope that these labeling recommendations will help in facilitating these discussions.”

[…]

Diana Zuckerman, president of the National Center for Health Research and its Cancer Prevention and Treatment Fund, also had a concern, pointing out that guidance from the FDA usually consists of recommendations that are not enforceable.

“That’s a big question for us,” she said in an interview with CURE®. “Because we know from experience that, if it’s a suggestion, there are just a lot of doctors who aren’t going to follow through. We think this needs to be required, and we will be working with the plastic surgeons’ medical societies to try to ensure that they urge their members in the strongest possible terms to use this checklist, either the FDA’s version of it or our version, which we think is better.”

An ongoing issue

The FDA also acted on testimony given at the March panel when it requested in July that Allergan, which was since purchased by AbbVie, issue a worldwide recall of any of its Natrelle Biocell textured implants and tissue expanders that remained on shelves. That’s because textured implants, particularly the Natrelle Biocell product line filled with either saline or silicone, have been linked with BIA-ALCL. As of Jan. 5, the cancer had been diagnosed in 733 patients and killed 36, the FDA reported Aug. 20.

“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” Dr. Amy Abernethy, the FDA’s principal deputy commissioner, said in July.

[…]

First identified about 20 years ago, BIA-ALCL is a rare type of non-Hodgkin lymphoma that arises specifically in women with implants. The FDA first warned women about BIA-ALCL in 2011.

Breast implant illness, meanwhile, seems to occur more often in women who have a personal or family history of autoimmune conditions, experts said, suggesting that more research is needed and that these women should be warned before getting implants. One expert at the 2019 hearing said that this group should opt against implants.

Jennifer Cook of Georgia, who received a diagnosis of BIA-ALCL in 2017, told the 2019 FDA panel that she received her implants as part of a clinical trial and signed a consent form stating that there was no established scientific evidence linking them with cancer. Over many years, she said, no one informed her that a risk had been established, and she found out only by watching a play on the topic at the middle school where she taught.

“I was shocked and thought I would need to reprimand the students for making false statements, and then I learned the horrifying truth,” Cook said. “Shortly thereafter, I recognized that I had symptoms. I was blindsided. I was deceived, and I don’t want anyone else to go through that.”

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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.

[…]

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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 Study Backs Breast Implant Illness Claims by Patients

We Are Quoted, ,

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

Women with Breast Implants Should Not Need to Wait for Safety Information They Urgently Need

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Rose Weitz and Diana Zuckerman, Our Bodies Ourselves: July 1, 2020

Although breast implants have been sold since the 1960s, the U.S. Food and Drug Administration (FDA) first approved the use of silicone gel breast implants in 2006. By then, many women with implants had already reported a range of problems, which result in many women seeking additional surgery within just a few years of implantation.

And the problems have become more serious. Last year, for example, Allergan did a worldwide recall of their textured Biocell breast implants and expanders because of evidence that these implants caused an increased risk of a type of lymphoma called ALCL.

The FDA has the authority both to require solid evidence of safety before putting any implant on the market and to require companies to collect health data from implant patients for years afterward. Without these data, it is impossible for women or their doctors to know what are the possible consequences of different implants, what symptoms to look for, and which implants should be surgically removed – assuming an individual knows the make and model of their implant and can afford up to several thousand dollars to remove it.

Collecting data is a small thing to ask of manufacturers who have been profiting from breast implants for many years. Yet even this has proven too much for these companies, or for the FDA to enforce. For example, in May 2019 the FDA sent letters to two manufacturers, Mentor Worldwide and Sientra, warning that the manufacturers had failed to collect the required data for implants that were already on the market and would need to improve their data gathering or face potential criminal or civil penalties. The FDA also sent warning letters in May 2020 to Allergan and Ideal. The FDA criticized Allergan for their failure to recruit and follow-up with as many patients as had been promised. The agency warned Ideal that the companies’ efforts to rectify previous problems were inadequate, including failing to accurately report consumer complaints, failing to keep adulterants out of its silicone, and failing to notify the FDA about malfunctions of its implants that could result in death or serious injury. Meanwhile, all these implants are still on the market.

Last October, in response to the pleas and demands of thousands of breast implant patients, the FDA proposed that a black box warning be affixed to all implant packages to inform women and their doctors about the most serious risks of breast implants. In addition, the FDA proposed that all patients be required to sign an easy-to-understand checklist of possible risks before implant surgery is scheduled.

These proposals were much weaker than what patients and their advocates had demanded. In response to the FDA’s request for public comments, a Working Group of patients, public health advocates, and plastic surgeons submitted a critique — along with a petition signed by over 70,000 people – urging the FDA to be more explicit about the proposed warnings. Public comments were due in December 2019, but as of June 2020 the agency has still not revised its proposal.

Buyer beware, indeed.

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“We Can’t Ever Go to the Doctor with Our Guard Down”: Why Black Women Are 40% More Likely to Die of Breast Cancer

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Maria Aspan: Fortune Magazine June 30, 2020

Racism kills Black Americans, and has long before COVID-19. But its toxic combination with sexism has particularly vast and disastrous consequences for the health of Black women.

While Black people in the U.S. are dying from the COVID-19 pandemic at a disproportionately high rate, this national health crisis underlines an even grimmer status quo: Black Americans are also much more likely to die from far more common and longstanding health problems every day. Black women are at particularly high risk of heart disease and strokes, and are at least three times as likely to die as a result of childbirth as white women, contributing to the overall alarmingly high maternal mortality rate in the United States.

Then there are the shocking statistics around breast cancer, which affects one in every eight women and is the most common non-skin cancer affecting women. Black women are less likely to develop it—but 40% more likely to die from it than white women, according to the U.S. Centers for Disease Control and Prevention.

The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it. Now the disproportionately high toll of COVID-19 on the Black population in the U.S. and the simultaneous national reckoning over racism are drawing new attention to the racial inequities hurting Black women—and amplifying the voices of doctors, scientists, and public health experts who have long sounded the alarm.

[…]

Women of all races could be legally omitted from government-funded clinical trials before 1993, and are still often under-represented in most research studies of conditions that affect them. Pregnancy and menstrual cycles are thought to “complicate” the results of trials that are mostly conducted on white men, who are seen as the “norm.”

This can obviously backfire. In 2013, the U.S. Food and Drug Administration sharply cut its recommended dosages of Ambien for women, after years of complaints about grogginess and falling asleep while driving, when followup tests showed that women metabolized the active ingredient in sleeping aids much more slowly than men.

When it comes to clinical trials funded by pharmaceutical companies, “the FDA encourages but does not require diversity in clinical trials,” says Diana Zuckerman, a scientist and president of the National Center for Health Research. “Worse, the agency frequently approves drugs and devices for all adults, even if they were primarily studied on white adults.”

One treatment that the FDA approved in April, for the “triple-negative” type of breast cancer that disproportionately affects Black women, was approved after being tested on 108 patients. Eight of them, or 7%, were Black. Another breast-cancer treatment was approved last year after being tested on 234 patients; seven of them, or 3%, were Black.

[…]

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