Category Archives: Uncategorized

Breast Implant Illness: Two Metro Women Say Implants Caused Years of Complications

Ben Oldach, WHO TV: May 21, 2018

Breast implants are the most popular form of plastic surgery in the United States. Katie Krug’s followed a botched breast reduction.

“There were quite a few people that asked me when I was in a bathing suit if I had open heart surgery, so it was something that I was really self-conscious about,” said Krug.

Krug’s friend Lisa Miller received hers while living in Arizona.

“I was just in a place where everyone had them, you kind of look outwardly and everyone had them,” said Miller.

What the women say happened next was not something they expected post-surgery.

“About a year later is when I started noticing some really small symptoms. I was tired a lot more, started having some brain fog, started being really sensitive to smells, and then it just seemed like every year it got worse,” said Krug.

“I would get really dizzy all of a sudden when I would be driving, I would get nauseous, then it moved into GI symptoms, so I started to have gastritis and had to have scopes and medicines,” said Miller.

Both women say they went to doctors who couldn’t figure out what was wrong, all while new symptoms were developing.

“I wasn’t sleeping whatsoever, I was staying up all night, I almost couldn’t work, I couldn’t remember, I was teaching Pilates at that time, I couldn’t remember what I was teaching, I really couldn’t get out of bed,” Miller explained.

After not finding any answers from doctors, Miller tried adjusting her life style.

“Cleaned the house, cleaned all the chemicals, all my beauty products, ate really well, I remember my girlfriend saying, after confiding in her, ‘you’re the sickest, healthiest person I know,'” she said.

Krug says in 2011, she asked her doctor about rumors that there may be a connection between her implants and the autoimmune disease she’d been diagnosed with.

“He pretty much just laughed in my face about the possibility of there even being a link, that they’re completely safe, they’re saline, I don’t have anything to worry about, and so I just really put that out of my mind until last year,” she said.

Meanwhile, Miller was at the end of her wits.

“I just remember like, laying on the floor one night and telling my husband, ‘I’m done! I’m done, I can’t manage life,'” she said.

Miller said her husband discovered the only thing that changed before the symptoms started showing up was her surgery, and after doing some research found a Facebook group of 35,000 women, all claiming similar symptoms. Around the same time, Krug found the page, too.

“I just felt I’m not crazy, there are other people out there like me, I see hope,” said Miller.

“I really wanted to cry when I found that page, it was so emotional for me,” said Krug.

The women in the group believe they are suffering or had suffered from something being called breast implant illness, although experts say it’s a symptomatic reaction rather than an actual disease.

“If you’re putting a foreign object in your body, it would be the same as someone saying that nobody gets a side effect from taking a medication. It’s very unrealistic,” said Josh Rose.

Rose is the patient concierge at Aqua Plastic Surgery in southern Florida. He works hand-in-hand with Dr. David Rankin, who he says performs hundreds of breast explant operations a year. However, he is quick to point out that as of now, there is very little published research linking the implants to these symptoms.

“There should be more research. There has been some research, so most of what we have to go by is very anecdotal. We’re hoping there will be more research. We’re starting our own research, another doctor is starting her own research,” said Rose.

Miller and Krug consulted with a local plastic surgeon who performs explants and had theirs removed. They say they immediately started feeling better. […]

Read the original article here.

After 17 Years with Breast Implants, Princeton Woman Leads Calls for More Education, Safety

Marie Saavedra, WFAA, April 16, 2018

A North Texas woman says her implants were making her sick. Now, she’s lending her voice to the call for more information to be shared between the FDA, doctors and patients.

Jamee Cook was 21, engaged to be married and a paramedic when she made a decision that would shape the rest of her life.

“I was really active. Healthy, Young, skinny,” she said. “I was always really really flat chested and wanted to be more proportionate.”

At age 21, Cook chose to get breast implants. At 40, it is her biggest regret.

“I mean, I made this decision and I own it,” she said. “And I do feel guilty about it because it took a lot of things away from me.”

She says that included her health. Three years after surgery she developed an auto immune disease.

“Then it went downhill, just chronic fatigue, swollen lymph nodes all the time, chronic sinus infections,” Cook said. “I couldn’t get out of bed, I was having migraines two or three times a week, and I had three young kids at home!”

She says doctors had no more answers, which left her feeling helpless. Cook turned to the internet and researched, and she came to realize her implants could be the source. She was certain when she removed them after 17 years.

“I still battle fatigue off and on, but the majority of my other symptoms went away immediately,” she said.

Cook then gained new purpose. She created the group Breast Implant Victim Advocacy, a community of thousands women who say implants made them ill. She lobbied for implant safety in Washington. All of it, driven by a simple goal.

“I think that a lot of women don’t get the information they need to make a fully informed decision,” she said.

Last year, the American Society for Aesthetic Plastic Surgery said surgeons performed 333,329 breast augmentations. We asked Dallas plastic surgeon Dr. Lawrence Weider about what warnings patients can currently expect to hear from their doctors.

“There’s a whole host of risks that we discuss,” said Dr. Weider. “We have a several page consent for that we go through with them.”

But Cook argues there’s more to be done. Right now, The FDA is researching the ties between a specific type of implant causing a rare lymphoma, and last month a woman suffering from that cancer sued an implant maker in California. […]

Read the original article here.

CMS Payment Rule Seen as Bad for Some Patients

Joyce Frieden, MedPage Today, April 10, 2018

New final regulations on the Affordable Care Act (ACA) health insurance exchanges issued by the Centers for Medicare & Medicaid Services (CMS) have drawn mixed reactions from health policy experts and others.

The rule makes a number of changes to the exchanges, including:

  • Expanding the number of “benchmark” plans from which states can choose to model their coverage of the 10 “essential health benefit” (EHB) categories included in the ACA, potentially allowing states to choose plans with more generous or skimpier coverage than is currently offered on their exchanges.
  • Adding several new “hardship exemptions” to allow consumers to avoid paying a penalty for not buying health insurance. One exemption is for consumers who live in an area in which there are no health plans offered for them on the exchange, or only a single plan offered which is unaffordable. Another exemption is for consumers who live in an area in which the only health plans offered provide coverage of abortions, in cases where that conflicts with the consumer’s personal beliefs.
  • Allowing states to adjust the “medical loss ratio,” which determines what percentage of a health insurer’s revenue must be used for paying healthcare costs. Currently, according to the ACA, health insurers must spend at least 80% of their revenue on healthcare claims and quality improvement, with the rest going toward overhead and profit.
  • Increasing the percentage premium increase which requires review by insurance regulators. Under current ACA rules, review is triggered if an insurer requests to increase rates by an average of 10% or more; the new regulations increase that threshold to 15%.

“The final rule will mitigate the harmful impacts of Obamacare and empower states to regulate their insurance market,” CMS said Monday in a press release on the regulations. “The rule will do this by advancing the Administration’s goals to increase state flexibility, improve affordability, strengthen program integrity, empower consumers, promote stability, and reduce unnecessary regulatory burdens imposed by the Patient Protection and Affordable Care Act.” The release also asserted that the ACA “has led to higher premiums and fewer choices” and that the ACA “has priced many consumers out of the insurance market.”

Premium Increases for Comprehensive Plans

“The plan to allow the sale of policies with skimpier essential health benefits will inevitably cause premiums for good health insurance policies (the kind currently available through the ACA) to increase,” Diana Zuckerman, PhD, president of the National Center for Health Research, an organization that conducts, analyzes, and explains health-related research, wrote in an email.

“If very healthy people can buy skimpy health insurance policies, then people who know that they have health problems will be the only ones buying the better policies — resulting in an increase in costs. In other words, people with pre-existing health conditions such as cancer, heart disease, diabetes, and rare diseases, will be paying much more than anyone else — an outcome that most Americans do not want. The bottom line is that the result of these regulations will be exactly the opposite of the stated goal: rather than making healthcare more affordable, this would make health care much less affordable for the people who need it most.” […]

Read the original article here.

Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?

Emily Kopp, Sydney Lupkin, and Elizabeth Lucas, Kaiser Health News: April 6, 2018

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies over 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania who co-authored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent — in varying degrees — about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups — with annual revenues as large as $3.6 million — relied on the pharmaceutical companies for at least 20 percent of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What Drives The Money Flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act — a law that required payments to physicians from makers of drugs and devices to be registered on a public website — but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015 the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as The National Women’s Health Network, based in Washington, D.C., make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.” […]

They Weren’t Always Backed By Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner — pharma or otherwise — decides our mission priorities,” including a scientific advisory board — free of sponsor influence — that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington — plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said. […]

Read the original article here.

The FDA’s Regulation of Silicone Breast Implants

U.S. Congress, Report of the Subcommittee of Human Resources and Intergovernmental Relations of the House Committee on Government Operations, 1993

The FDA’S Regulation of Silicone Breast Implants

I. Introduction

Under the Rules of the House of Representatives, Rule X, 2(b)(2), the Committee on Government Operations is authorized to “review and study, on a continuing basis, the operation of Government activities at all levels with a view to determining their economy and efficiency.” The committee has assigned this responsibility, as it pertains to the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), to the Human Resources and Intergovernmental Relations Subcommittee.

Pursuant to its authority, the subcommittee conducted an investigation of the safety and effectiveness of silicone breast implants, the regulation of those devices by the FDA, and research support by the NIH.

On December 18, 1990, the subcommittee conducted a hearing on the FDA’s regulation of silicone breast implants. The hearing included testimony from the following FDA witnesses: Walter Gundaker, Acting Director, Center for Devices and Radiological Health; Mr. Robert Sheridan, Director, Office of Device Evaluation; and Dr. Joseph Arcarese, Director, Office of Training and Assistance. Other witnesses included Dr. Nir Kossovsky, assistant professor of pathology and laboratory medicine at the University of California at Los Angeles; Dr. Frank Vasey, professor of medicine at the University of South Florida; Dr. Pierre Blais former senior scientific advisor for the Department of National Health and Welfare of Canada; Dr. Norman Anderson, former Chair of the FDA panel that reviewed the breast implant issue in 1988-90; Mr. Thomas D. Talcott, an engineer specializing in silicone implants for 20 years at Dow Corning; and Mr. Robert Rylee, vice president of Dow Corning Wright. Implant patients Sybil Goldrich, co-founder of Command Trust Network; Rosemary Locke of My Image After Breast Cancer; and Janet Van Winkle, founder of the American Silicone Implant Survivors (AS IS), also testified. Officials of three other manufacturers, Mentor, McGhan, and Surgitek, declined the subcommittee’s invitation to testify.

[…]

Read the original article here.

Testimony of Linda MacDonald Glenn at the FDA on Silicone Gel Breast Implants

Linda MacDonald Glenn, Women’s Bioethics Project, April 2005

My name is Linda MacDonald Glenn. And I am testifying today on behalf of the Women’s Bioethics Project, a nonprofit, nonpartisan public policy institute dedicated to ensuring that women’s voices, health, and life experiences are brought to bear on ethical issues in healthcare and technology.

I am a biomedical ethicist, attorney, educator, and long-time patient advocate. I spent 20 years as an attorney, a prosecutor, government adviser, and general practitioner. During that time, I was called to the field of biomedical ethics, both personally and professionally. I went back to school to switch my career to biomedical ethics.

Upon graduating in 2002, I went to the American Medical Association, where I was a senior fellow at the Institute of Ethics. I hold a faculty appointment at the University of Vermont. And I was recently given the honor of being named a Woman’s Bioethics Project scholar. I have no financial conflict of interest.

“Tell me what you don’t like about yourself.” This catchphrase is the opening line to the controversial TV drama “Nip/Tuck” that sums up a plastic surgeon’s attitude towards his patient. The implication is that plastic surgeon can fix what you don’t like about yourself.

And while we’re not here today to talk about plastic surgery, we are here to talk about the new silicone breast implants, which manufacturers have promoted as a woman’s choice; in other words, “Let us help you feel better about yourself.” But, as I will follow up and explain, the FDA’s summary of the manufacturer’s own reports indicate that this is a hollow promise.

There are some key ethical issues involved in your decision today. Issues of long-term safety and truly informed consent are the primary concerns.

In biomedical ethics, there are four principles that are weighed and balanced against each other to arrive at an ethically sound decision. Those are the principles of autonomy, the right of control over your own body; benefit, the good that is accomplished from the treatment and the application of technology; no harm, the risks and burdens of the treatment; and justice, a question of fair and equitable access.

The public relations firm hired by the breast implant companies came up with a slogan, “Women have the right to choose breast implants, which chooses to emphasize autonomy. However, if autonomy were the only principle to be considered, there would be no need for the FDA. And there would be no protection against the claims of charlatans and those peddling magic elixirs.

The slogan “The right to choose” implies a benefit that a woman will feel better about herself and her appearance, but, in fact, the data submitted by Mentor Corporation does not bear out that benefit.

Mentor’s own data and the data that Inamed provided in 2003 both showed that on most measures, women feel the same about themselves and their lives two years after getting breast implants compared to before getting breast implants. That is consistent with other research as well, as shown in the FDA summary of Mentor’s reports on pages 66 to 73, indicating there is no measurable benefit for women who have received breast implants.

To quote, in summary, the literature does not provide strong scientific support that breast implants have a measurable psychological and psychosocial benefit for women seeking breast augmentation. Each study had serious flaws, including the apparent exclusion of participants with adverse outcomes. This was true for augmentation and reconstructive patients.

The summary on page 73 explains that Mentor did not provide adequate literature that evaluates the short-term or long-term psychological or psychosocial benefits of breast implants as a reconstructive procedure.

The burdens and potential risks are substantial, not only the risks of invasive major surgery but also serious questions about long-term safety issues regarding silicone leakage, silicone migration, and resulting autoimmune disorders.

Research of women with implants for at least six years found that one in five women had silicone leaking outside the scar capsule and didn’t even know it. Clearly, more studies on long-term safety need to be done.

In terms of ethically sound decision-making, this is what I would call a slam dunk for the Committee. Autonomy, the right to choose, is not a factor when the benefits are not measurable and the burdens and risks are significant. The path this Committee ought to take is clear. These implants should not be approved until clear benefits and long-term safety are established.

Thank you for your thoughtful consideration in listening today.

Testimony of Marcy Gross at the FDA on the Lack of Breast Implant Studies

Marcy Gross, State of Maryland Women’s Health Promotion Council, April 2005.

I am Marcy Gross, a consultant who specializes in women’s health issues. I am a member of the State of Maryland Women’s Health Promotion Council and serve on the boards of various private health organizations.

Prior to becoming a consultant, I worked for the Department of Health, U.S. Department of Health and Human Services, where I was a Senior Policy Analyst for a number of years in the Office of the Assistant Secretary for Health. And in my last position, I was the Senior Adviser for Women’s Health at the Agency for Healthcare Research and Quality, where I served while there on the secretarial ad hoc task force on silicone breast implants.

I give you this resume to establish my familiarity with the issues at hand. However, I am speaking as a private citizen. I have no financial links to any of the applicants.

A legacy from my six-year tenure at AHRQ is an appreciation of the need for a strong evidence base to support medical decisions. One of my concerns today is that an adequate evidence base for the approval of silicone gel breast prosthesis still does not exist. Worse, a truly long-term gold standard study that will produce independent, objective research findings seems not to be on the horizon.

We do have 40 years of experience with breast implants, including 25 years when the silicone implants were available to women, all women. They were pulled from the market for good reason. They were associated with major medical problems.

The basic facts on this issue have not changed in the 14 years subsequent. First, available studies on the health aspects of silicone gel implants are still short-term and are often produced by companies that manufacture the devices or materials.

Second, the work that is available, some from FDA itself, indicates that the rate of complications of implantation, reinfections, reoperations, and other adverse events are sufficiently high to remain a major concern, despite advances in materials.

Third — and this is a change from the past — the Mentor applicant agrees that the devices will not last indefinitely and warned women that they should expect to have them replaced. So the issue becomes one of sequencing in looking at the data. Do we get the data first and approval after or the reverse?

Letting women be living testers I find highly objectionable since these are elective procedures and there are alternatives, especially since the data on improvements in the quality of life for patients undergoing implantation are weak by accepted research standards and most especially since it is expected the devices will fail and will have to be removed.

On this last point, the overall failure rate, it should be noted that Mentor acknowledges that their devices will have a finite in vivo life, which means, really, that all will fail and need to be surgically removed. We just don’t know when.

I would assert that if this were an NIH-funded research study, it’s unlikely it would go forward.


Marcy Lynn Gross passed away unexpectedly on June 19, 2005. Marcy was an important national advocate for women’s health, and formerly a senior adviser with the U.S. Department of Health and Human Services. She worked closely with the National Research Center for Women & Families to prevent medically-unnecessary mastectomies. The Center is naming an internship in her honor.

The Costs of Revising or Removing Breast Implants


Breast implant complications are common. Based on studies conducted by implant companies, the FDA concluded that between 20-40% of augmentation patients required at least one additional implant surgery within 8-10 years1. These revision surgeries often cost as much as the initial surgery, if not more. Revision surgeries might involve replacing implants or correcting the visual appearance of breast implants. Since many women dropped out of the implant companies’ studies, the proportion of women needing additional surgery could be much higher. You can read more about possible breast implant complications here.

If problems with your breast implants are bad enough or can’t be fixed, it may be necessary to remove your implants.

In 2016, the average surgeon’s fee for removal of breast implants was $2,506 but that does not include all the costs of surgery2. Our review of various plastic surgery websites revealed that the total average cost for breast implant removal is $5,000-$7,000. You can expect to pay an additional $2,500-$3,500 if you choose to replace your implants or about $5,000 if you choose to have a breast lift. A breast lift is a one-time expense but the replacement implants are likely to need to be replaced in later years. The cost of removal varies by surgeon, geographic region, and the complexity of the procedure.

Implant companies admit that breast implants will not last a lifetime. When saline implants leak, it is obvious because they deflate quickly, so the breast looks smaller. When silicone gel breast implants leak, there often are no symptoms at first. Silicone can leak out of the hole in the implant and travel to parts of the body where surgeons can’t remove it. Leaking silicone could cause pain, burning, and allergic or autoimmune reactions. These symptoms may result in additional medical costs. Removal of breast implants can be very expensive, especially if they are leaking silicone gel. In fact, some patients have reported paying $20,000 or more.

Due to concerns about leaking silicone, the FDA recommends that women with silicone gel breast implants get an MRI to check for leakage after 3 years — and then every other year after that. Unfortunately, a breast MRI costs about $2,000, and sometimes more. Though the MRI scan is expensive, it is the most accurate way to know if your implants are leaking. Your insurance plan might not cover things like an MRI or consultations with your doctor, so expect to pay for it yourself. If they are leaking, it is important to have them removed as soon as possible. You can read more about removing breast implants here.

Some insurance companies do not cover the costs of removal if your implants were placed for cosmetic reasons. Insurance plans that do cover removal require that patients prove that explant surgery is medically necessary. Symptoms that are considered medically necessary reasons for breast implant removal include rupture, capsular contracture (Baker level III or IV), infection, and chronic pain. You will also need a doctor to advocate for you and communicate to your insurance company that removal is medically necessary. You can read more about trying to get insurance coverage for your breast implant removal here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Food and Drug Administration. Breast Implants: Local Complications and Adverse Outcomes. Retrieved from https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM548169.pdf
  2. American Society of Plastic Surgeons. Breast augmentation cost. Retrieved December 20, 2017, from https://www.plasticsurgery.org/cosmetic-procedures/breast-augmentation/cost

Testimony of Anne Kasper, PhD at the FDA on Silicone Gel Breast Implants

Anne Kasper, PhD, Finding My Way, October 14, 2003

My name is Dr. Anne Kasper and I am a partner in Finding My Way, a support service for breast cancer patients in Bethesda, Maryland. I am also the senior editor and author of the book Breast Cancer: Society Shapes an Epidemic.

Breast cancer patients have more choices than ever before. While it’s important to have choices, when a woman is diagnosed with breast cancer, the choices can be difficult to make.

• Three out of four women newly diagnosed with breast cancer can choose to have a lumpectomy with radiation instead of mastectomy.

• If a woman needs or wants a mastectomy, she can choose saline breast implants, silicone gel implants, or autologous tissue transfer procedures.

How important is it that silicone gel breast implants be widely available to cancer patients? Under the current restrictions, the vast majority of women who want silicone gel implants for reconstruction are able to get them.

But, breast cancer patients tend to be cautious. They want to live long lives. However, they also are concerned about cosmesis and how they will look after cancer treatment. Many will choose lumpectomy, which allows them to keep their breasts, preserving their appearance and the sensory feelings of the breasts. Women tell us that they only want silicone gel implants if they can be assured that they are safe. Women are often encouraged to choose implants and a rosy picture is painted about the benefits of implant reconstruction. However, in our practice women are often disappointed to have reconstructed breasts that have none of the sensory, sexual, and maternal capacities of a normal breasts and that often have complications.

Many reconstruction patients who choose silicone gel implants are happy with their implants at first. Unfortunately, many women experience the kinds of complications that Inamed found, such as:

46% will need additional surgery within 2 or 3 years
25% will have their implants removed within 2 or 3 years
6% will have a ruptured implant
6% will have moderate to severe breast pain
6% will suffer from necrosis, a complication in which their skin or breast tissue dies and the wound takes a long time to heal

In the Inamed core study of breast cancer patients, only 6% of the implants broke during the first 2 or 3 years, but over time we know that percentage increases. This is much more serious than when a saline implant breaks. When silicone gel implants break, the silicone can leak into the lungs, lymph nodes, and other organs. To determine the safety of silicone gel implants, Inamed should have studied the health of women whose implants broke — especially since cancer patients have compromised immune systems. Unfortunately, they did not.

Another shortcoming of the Inamed research is that it included only 6 African American breast cancer patients in the core study and only 5 Asian American women. Obviously, this is not appropriate data on which the FDA could make a safety decision for all American women. Both groups have approximately the same rates of cancer as white women, and African American women are especially susceptible to autoimmune disease. These women must be studied to determine if implants are safe for them.

The bottom line, though, is that the complication rates for breast cancer patients are very high in just the first two or three years. What will these women’s lives be like in the next 5 or 10 or even 20 years? Most breast cancer patients are living long lives. Many choose mastectomy as a way to “get it over with” and “put cancer behind them.” With re-operation rates of 46% in the first two or three years, and higher rupture rates in the years to come, many women will not consider implants a satisfactory and safe choice at all.

It is unusual to ask for more than 2 years of safety data for a new product, but silicone gel breast implants are not new. Inamed is asking for approval for an implant that has not changed much if at all in more than a dozen years. If FDA had strictly enforced their restrictions on breast implants, which were established in 1992, we would have 10-year data by now, instead of 2-3 years.

If the FDA approves silicone gel implants based on the data provided, it sends the message that they are not as concerned as women have a right to expect about the health and safety of breast cancer patients, and especially women of color.

If the FDA allows silicone gel implants to remain on the market, but only as part of clinical trials, and this time requires a third party to monitor the studies, then perhaps breast cancer patients will finally get the information they need to make a meaningful choice.

Testimony of Claudia Miller, MD at the FDA on Silicone Gel Implants

Claudia Miller, MD, University of Texas Health Science Center, April 2005.

My name is Dr. Claudia Miller. I have no financial interests in this hearing, and I’m here at my own expense. I’m a professor at University of Texas Health Science Center in San Antonio. I’m an allergist/immunologist. And my research is focused on people who report chronic disabling symptoms following some environmental exposure, the symptoms you have heard about today.

I have served as a consultant to the Department of Veterans Affairs on Gulf War veterans, the EPA on sick buildings, the National Institute of Dental and Craniofacial Research on temporomandibular joint implants, where, by the way, you see similar kinds of complaints.

What unites ill Gulf War veterans, sick building occupants, and patient with implants who are having problems is the fact that following a well-defined exposure event, a subset, not every one, a subset of them, go on to lose their prior natural tolerance for a wide variety of substances that are structurally unrelated.

Thereafter, common foods, medications, alcoholic beverages, caffeine, chemical inhalants, like diesel exhaust, and fragrances you have heard about today, exposures that never bothered people before suddenly trigger symptoms in them. And these can be disabling.

This two-step disease process — and has come to be known as toxicant-induced loss of tolerance, or TILT. It does not appear to matter whether the exposure that initiated this, which is at the bottom of the right-hand slide, was endogenous or exogenous. The body’s response is remarkably similar.

We have reported on 87 individuals with surgical implants, three-quarters of them with breast implants. Sixty-nine percent reported rupture. Seventy-eight percent had one or more implants removed. Of those who had undergone explanation, less than ten percent reported their health status as greatly improved.

Using a validated questionnaire, we found that the symptom severity scores of implant recipients rivaled those of the environmental exposed groups we were studying. And there were four of those.

Compared to controls, implant recipients reported much more severe adverse responses to everyday chemical exposures as well as having problems with various foods, medications, alcoholic beverages, and caffeine.

Toxicant-induced loss of tolerance is a new paradigm for environmentally induced disease that differs from classical toxicity and allergy.

Affected individuals may be completely unaware of the intolerances resulting from this because of a phenomenon we call masking. If a person is reacting to many different things and having symptoms as a result of those, then the symptoms may overlap in time. And, consequently, they feel sick all of the time, often reporting chronic fatigue or flu-like illness that won’t go away.

Recent Canadian studies show that genetic polymorphisms may determine who is more vulnerable to developing this illness. And in September I will be chairing a meeting on the toxicant-induced loss of tolerance sponsored by two NIH institutes where we’ll be discussing various aspects, clinical models, animal models, and so on, in order to understand this problem better in providing you with a questionnaire that I showed a moment ago to help physicians and researchers better understand this problem.

And I will be happy to provide you with any references. Thank you.