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NCHR Public Comment to FDA on Breast Implant Safety

National Center for Health Research, April 26, 2019


National Center for Health Research Public Comment on General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting [FDA-2019-N-0426].

Thank you for the opportunity to provide comments on FDA’s General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee meeting on breast implants. The
National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts focused on research, programs, services, and policies that affect public health. Our Center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from companies that make medical products, so we have no conflicts of interest.

Our Program to Help Women Seeking Insurance Coverage for Implant Removal

Since its founding in 1999, our Center has heard from thousands of women who told us that their breast implants have caused serious health problems. In 2015, we began to offer a program that helps women navigate their health insurance policies so that they can get coverage when the removal of breast implants is medically necessary. In the past 3 years, more than 6,000 women have contacted us, and the number continues to grow dramatically. Some weeks we are contacted by more than 200 new women seeking our help to get their breast implants removed because of serious medical problems. Their reasons for needing their implants removed include leaking and ruptured breast implants, chronic pain from capsular contracture or from implants that are too large, autoimmune or connective tissue symptoms or diseases (referred to as “breast implant illness”), and ALCL. Some women contact us after recently developing symptoms from their breast implants, while others have been living with chronic health issues for years but either did not know they might be related to their breast implants or did not have the financial resources to have their implants removed. Prior to passage of the Affordable Care Act, breast implants were considered a “pre-existing condition” and explant surgery was almost never covered by health insurance.

Most women tell us that had they known that breast implants might cause these serious health problems, they never would have gotten them. We hear every day how women trusted their doctors when they were told that breast implants were safe and that complications were rare.

Recent research on 123,255 Israeli women by Watad et al. concluded that breast implants
significantly increase the chances of a woman being diagnosed with several autoimmune
diseases, such as rheumatoid arthritis and Sjogren’s Syndrome. However, because the FDA has repeatedly denied a link between autoimmune or connective tissue symptoms and breast implants, insurance companies will rarely pay for the removal of implants for women with symptoms of breast implant illness, such as joint or muscle pain, chronic fatigue, mental confusion, rashes, hair loss, and persistent flu-like symptoms. Of the thousands of women who seek assistance from our organization, only about 20% are able to get their implants removed. Even fewer get insurance coverage for their medically necessary explant surgery. The rest have to empty their savings, rely on credit cards or loans, or borrow money from friends and family. Unfortunately, most women who are unable to get insurance coverage for their breast implant removal are also unable to afford to pay out-of-pocket for explant surgery, which is why so many live with debilitating symptoms and escalating health problems for years. What might start as gradual increases in symptoms become so debilitating that many of the women lose their jobs (and with it, often their insurance), their ability to care for themselves or their families, and sometimes their spouses.

Implications for the Registries

The PROFILE Registry is intended to gather information about patients with BIA-ALCL, but not other health problems. The National Breast Implant Registry is designed to include as many Board-Certified plastic surgeons and their patients as possible, and therefore focuses only on re-operations – information that is relatively easy for physicians to document. It does not include information about the range of life-changing symptoms that thousands of women have reported, and also fails to include the thousands of women who need to have their implants removed, but are financially unable to do so. As we have found in our program assisting women who desperately seek insurance coverage for explant surgery, the number of women who have their implants removed and not replaced is only a small percentage of the number of women who want explant surgery because of medical problems. The registry needs to be substantially improved by including information about the autoimmune and connective tissue disease diagnoses as well as the moderate to severe symptoms that women refer to as breast implant illness. In addition, registries need to include information from primary care physicians and non-surgical specialists who are often conducting medical tests in an effort to determine the cause of the women’s symptoms. Most women who experience autoimmune or other symptoms from their breast implants are making appointments with primary care physicians, rheumatologists, neurologists, and other specialists; they rarely return to their plastic surgeons because those symptoms aren’t clearly related to their implants. Moreover, they tell us that when they go to a plastic surgeon because they have heard from other patients that the symptoms may be related to their implants, most surgeons tell them they are mistaken.

Another major shortcoming of the current Registry is that the data from the Registry is not
available to researchers or the public unless the ASPS Foundation chooses to make it public. Since the FDA considers registries an important aspect of post-market surveillance, it is essential that the data be available to anyone who wants to analyze it.

If Implants Can Cause Serious Symptoms, Will Removal Improve Health?

Our Center recently conducted a study of 449 women who had sought our help and succeeded in having their implants removed in 2016, 2017, or 2018. Fifty-seven percent of the women filled out our online questionnaire, all between November 2018 and January 2019. All of the women who we contacted had provided medical information to us when we had previously tried to help them obtain insurance coverage for explant surgery. Fifty-nine percent of the women in the study had symptoms for more than 5 years before they had their breast implants removed and 25% reported having symptoms for more than 10 years before explant surgery. These findings are consistent with patients’ testimony at the FDA meeting and with what thousands of patients have told us over the years: Many women have had debilitating symptoms for years, but did not know they were linked to their breast implants. So, instead of removing their implants when they first noticed health problems, they waited years, and sometimes decades, to seek explant surgery without replacement. Whether because of lack of money or lack of information that their symptoms were caused by their implants, our findings suggest that a short, easy-to-understand booklet and informed consent checklist could help warn women with limited financial resources about the risks of breast implants and also help women recognize their symptoms and consider explant surgery as an option before their health deteriorates.

We asked about family and personal health history and found that 69% of the women in our study reported a family history of autoimmune disease, 3% reported a personal history of autoimmune symptoms prior to getting implants, and 51% of the women reported that they were newly diagnosed with an autoimmune disease after getting breast implants.

Using a Likert scale with responses ranging from “much worse” to “much better,’ 61% of the women reported that their symptoms were much better since getting their implants removed and an additional 29% reported that their symptoms were somewhat better after having their breast implants removed. After performing a logistic regression to determine the factors that independently predicted health improvement after explant surgery, having explant surgery that removed as much capsule as possible predicted improvement after explant, as did not having a family history of autoimmune disease.

Implications for Informed Consent

Although all implant companies have patient booklets, in our experience most women report never seeing those booklets. In addition, the booklets are much too long and technical; they range in length from 55 to 180 pages, and include a great deal of information that is difficult to understand or promotional rather than informational. Nevertheless, the patient booklets include important information, such as the warning that breast implants were not studied on women with a history of autoimmune disease and therefore the safety of implants is not established for those women. However, there is so much information in these lengthy booklets that these types of important warnings are unlikely to be noticed by either doctors or patients that read them.

Although all patients sign an “informed consent” document, many are too technical for the
average patient to understand and include information that may be vague or confusing. They are often signed without having been carefully read. Informed consent is supposed to be a process, not just a piece of paper. Patients tell us that regardless of what the informed consent forms stated, their plastic surgeons were very reassuring about how safe implants are, rather than being candid about the risks. At the FDA Advisory Committee meeting on March 25-26, many plastic surgeons spoke about how carefully they provide informed consent to their patients, but those claims were undermined by the fact that many of those same surgeons stated that their patients are very happy with their implants, that ALCL is very rare and ‘not a big deal’ if caught early, and that the symptoms of breast implant illness are the same symptoms that all women tend to have. It is obvious that these physicians are unable to provide objective, informed consent about risks if they think the risks are minimal or non-existent.

Improving Informed Consent

Women need better informed consent in terms of written material and in terms of what their physicians tell them. Patient booklets specific to each company and implant model should be no longer than 20 pages and written at an 8th grade reading level, which is the reading level recommended by health educators. They should include easy-to-understand information about complications and risks, including information about BIA-ALCL and symptoms of breast implant illness. They should also include information from studies indicating that many women with breast implant illness experience significant improvement when their implants and scar capsules are removed. The writing of these booklets should require consensus among a group of experts that includes patients harmed by implants and their physicians, Board-certified plastic surgeons who put in breast implants and Board-certified plastic surgeons who primarily explant, the relevant implant manufacturer, and health educators.

In addition, there should be a required checklist, no longer than 3-4 pages, that is similar to the one that the FDA required for Essure, that provides information about the potential risks of all breast implants including BIA-ALCL and breast implant illness. These should be read and signed by patients and their doctors prior to any nonrefundable deposits for surgery. The checklist should include a black box warning regarding BIA-ALCL and breast implant illness, and information about the potential improvement in health for women who have their implants removed and not replaced.

In conclusion, we urge the FDA to require an informed consent checklist that specifically and succinctly warns of the symptoms and disease development risks that the patients at this meeting have reported. We ask that the FDA require manufacturers to complete the large, long-term studies that evaluate systemic symptoms. And finally, we urge the FDA to develop a national registry that includes symptoms as well as re-operations.

Thank you for the opportunity to comment on this important issue.

For more information, please contact Diana Zuckerman, PhD, at dz@center4research.org.

Public Comments by Women’s Health Experts on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting


National Center for Health Research Public Comment on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

Thank you for the opportunity to provide comments on FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

We are writing on behalf of five nonprofit health organizations that have examined issues pertaining to women’s health for decades and have considerable expertise concerning breast implant safety issues. None of these organizations have financial or professional conflicts of interest pertaining to breast implant devices or surgery:

  • Breast Cancer Action is a national nonprofit grassroots membership organization with members across the country who are challenging the status quo and working to address and end the breast cancer epidemic.
  • The Jacobs Institute of Women’s Health identifies and studies aspects of healthcare and public health, including legal and policy issues, that affect women’s health at different life stages.
  • The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety.
  • The National Women’s Health Network (NWHN) is a non-profit advocacy organization that works to improve the health of all women by supporting informed consumer decision-making.
  • Our Bodies Ourselves is a nonprofit educational and advocacy organization that has advanced the health and human rights for girls and women for almost 50 years.

As a follow-up to the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on breast implants, we are writing to express our views and concerns about the current status of information about breast implants and the role of the FDA in regulating the devices.

1. There is insufficient research to determine the long-term safety of breast implants. The clinical trials submitted to the FDA have numerous shortcomings:

  1. They excluded women with a history of autoimmune disease.
  2. They had an unacceptably high “loss to follow-up.” At the FDA meeting, FDA scientists presented data from studies that had lost up to 85% of the patients to follow-up, even in the revised studies that had already eliminated the 95% of patients who had dropped out. Those revised studies were already hopelessly biased, and presenting the data as if it were meaningful was unacceptable. And, the numbers of patients were also unacceptably small in many cases, with several reconstruction and revision patient groups represented by less than a dozen patients. Accurate information on the safety of breast implants cannot be gleaned from studies with such inadequacies.

The studies of autoimmune and connective tissue disease funded by industry and plastic surgeons had a different set of problems:

  1. Many included small number of patients, some of whom had breast implants for short periods of time, ranging from one month to just a few years. This is not relevant to long-term safety issues, since implants tend to deteriorate and rupture over time.
  2. They evaluated the number of women with diagnoses of rare diseases, but did not include women with symptoms of those diseases, nor did they have the statistical power to evaluate significant differences between women with implants and women without implants.
  3. Many evaluated the number of women hospitalized with those rare diseases or whose medical records specified those diseases, but the studies included women who had implants for such a short time that it was unlikely that the women had yet been diagnosed or hospitalized.

2. Most women do not receive objective informed consent regarding the risks of breast implants during the decision-making process. When the FDA approved breast implants, the agency required that plastic surgeons share information about the risks in a patient booklet. Unfortunately, most women say that they do not receive these booklets prior to surgery, and the booklets themselves are too long and complicated to provide useful information to patients. For example, although the patient booklets warn that the safety of breast implants have not been studied in women with a history of autoimmune disease, that information is difficult to find in these 44-202 page patient booklets.

3. To improve informed consent, women considering breast implants need a shorter, easy to understand patient booklet, which harmed patients should help to write. These booklets should include quantitative data on risks of the company’s implants for augmentation patients and reconstruction patients that are easy to understand. As experts in educating women on health issues, we would be glad to participate in writing these booklets as well. In addition, we strongly urge that the FDA require a short, user- friendly check list that provides balanced information about the risks, similar to the 3- page check list that the FDA required doctors and their patients to sign to inform them of the possible risks of Essure. The current informed consent checklists provided by some implant companies are vague consent forms rather than specific information acknowledging the risks. Informed consent checklists should explain all of the associated risks, encourage informed and shared decision making by the patient, and ultimately prevent long-term harm. It should clearly and succinctly state the risks that can occur with breast implants, including BIA-ALCL, the possibility of autoimmune symptoms, the need to remove the implants as they age and rupture, and the cost of MRI screening for silent rupture. The checklist should include a black box warning about BIA-ALCL and breast implant illness. The checklist should also include information based on studies indicating that women with breast implant illness are significantly more likely to improve after their implants and capsules are removed.

4. Since almost all cases of BIA-ALCL are associated with textured breast implants, implant companies that make textured implants should be required to conduct large retrospective studies to evaluate if the implants have any benefits compared to smooth implants. Some plastic surgeons believe that textured implants are less likely to cause capsular contracture and some other problems, but the FDA has not vetted any data to support those claims. Similarly, the use of mesh in breast reconstruction has not been scientifically studied to determine risks or benefits, and FDA should add warnings to the label and the FDA website about that off label use. In the meantime, textured breast implants should carry a black box warning about BIA-ALCL and that information should be provided orally and in writing to all women considering implants.

5. The newly designed breast implant registry tracks only the rates of reoperation, not other complications or health problems of women with breast implants. In addition, the National Breast Implant Registry misses the thousands of women who need to have their implants removed, but are financially unable to do so. To provide useful information, the registry should include information about important, debilitating autoimmune and connective tissue disease symptoms associated with implants. Registries should include relevant medical information from physicians other than plastic surgeons. In addition, the data from the registry are not available to the public unless the plastic surgeons chose to publish information. To improve transparency and informed decision- making by physicians and patients, data from the registries should be made available for free to the FDA, independent researchers, and the public to be analyzed and published.

6. We strongly urge the FDA to require manufacturers to complete large, long-term studies that evaluate the serious symptoms that patients described at the FDA Advisory Committee meeting. Well-designed studies were required as a condition of approval more than a dozen years ago, but those studies were not properly completed, due to enormous loss to follow-up. The FDA should require such studies now, and this time the research requirements should be enforced and implants taken off the market if the studies are not completed as promised.

In summary, the lack of good data, the lack of informed consent, and the lack of unbiased information for women who have become seriously ill from their breast implants are major shortcomings that FDA can help to remedy. We would be glad to share our expertise with you. Please feel free to contact the leaders of our organizations for additional information: Ms. Karuna Jaggar, Dr. Susan Wood, Dr. Diana Zuckerman, Ms. Cynthia Pearson, and Ms. Judy Norsigian.

FDA Plans Meeting to Discuss Safety Data on Breast Implants

Marilynn Marchione, Associated Press: September 14, 2018.

U.S. health regulators say they’ll convene a public meeting of medical advisers next year to discuss new science on breast implant safety, including an independent analysis that suggests certain rare health problems might be more common with silicone gel implants.

The Food and Drug Administration said it would hold the meeting even as its officials and several independent experts disputed the new work. Leaders of the study concede that it has big limitations and cannot prove that implants cause any of these problems.

Yet it involves nearly 100,000 women and is the largest long-term safety analysis of silicone implants since 2006, when they were allowed back on the U.S. market after a 14-year gap due to safety concerns.

“We completely stand behind this study and we do feel it’s our best data to date,” said lead researcher Dr. Mark Clemens, a plastic surgeon at the University of Texas MD Anderson Cancer Center. Women need as much information as possible to make an informed decision about whether and what kind of implant to get, he said.

The journal Annals of Surgery plans to publish the report on Monday. Study leaders have no current ties to implant makers although Clemens consulted for one in the past.

A POPULAR CHOICE

Each year in the U.S., about 400,000 women get an implant and most choose silicone over saline; surgeons say it can give a more natural look. Three-fourths are for women who want bigger breasts; the rest are for reconstruction after cancer surgery.

“Breast implants are not lifetime devices” and up to 20 percent of women getting them for enlargement need to have them removed within 8 to 10 years, the FDA’s website warns.

Complications can include infections, wrinkling, scarring, pain, swelling and implant rupture. Implant users also may have a very small but increased risk of a rare lymphoma, a type of cancer, the FDA has said.

But the agency decided there was not enough evidence to tie silicone implants to other problems such as immune system and connective tissue disorders, so it approved devices from two makers — Allergan and Mentor Corp. — in 2006. FDA required the companies to do more studies on how women fared, and the Texas researchers used these reports in an FDA database for their analysis.

WHAT THEY FOUND

Compared to women without implants, those with silicone implants seemed to have greater rates of an immune system disorder called Sjogren syndrome, a connective tissue disorder called scleroderma, and the skin cancer melanoma, although cases of these were rare, the researchers reported. But rates for other problems such as fibromyalgia were lower among implant users. Reproductive problems such as birth defects and stillbirths were mixed and inconsistent.

Furthermore, a higher rate of rheumatoid arthritis was tied to one brand but a lower rate for another. The difference gets to what critics called a fundamental flaw in the data used for the analysis: One implant maker required proof of diagnosis by a doctor rather than just a patient reporting a problem to include it in the database; the other did not.

Another study weakness is that more than half of women dropped out of touch within two years of their operations.

Because of these and other shortcomings, “we respectfully disagree” with the researchers’ conclusions and urge that they be viewed with caution, Dr. Binita Ashar of the FDA’s Center for Devices and Radiological Health said in a statement.

WHAT OTHERS SAY

“This study is messy” and has the potential to create more anxiety than insight, said Dr. Andrea Pusic, plastic surgery chief at Brigham and Women’s Hospital in Boston and president-elect of the Plastic Surgery Foundation, which supports research and advocacy by the American Society of Plastic Surgeons.

The group gets industry grants for some of its work, and Pusic gets royalties from a questionnaire used in many studies including this one.

Dr. Charles Thorne, plastic surgery chairman at Lenox Hill Hospital in New York and president elect of the American Society of Aesthetic Plastic Surgery, said the inconsistency in some of the results “is a little hard to explain” since the devices are similar chemically.

But the study is a worthy effort, he said.

“We have to constantly reevaluate the data and make sure things are safe,” Thorne said. “The best evidence we have now indicates there’s no increased likelihood of these systemic diseases.”

Read the original article here.

Breast implants making women sick? Florida women take their case to Washington

Daralene Jones, WFTV News: September 12, 2018.

CENTRAL FLORIDA – Local women are taking their fight against breast implants to the nation’s capital.

They first contacted 9 Investigates more than a year ago with claims their silicone gel-filled implants made them sick, and that they only got better once the implants were removed.

An FDA spokesperson confirms the closed-door meeting to 9 Investigates. The public and media were not allowed to attend.

The Central Florida women who attended the meeting said they want more transparency about the ingredients as well as better public awareness about risks that sometimes don’t show up for years.

They also want manufacturers to provide doctors with a checklist – that must be signed — warning women about illnesses some feel are only caused by implants and a rare cancer that’s already been linked to them.

“I’m still having trouble digesting food,” said Terri Diaz, who was one of 20 women who recently went to Washington to meet with the FDA.

Diaz is still trying to get her body back to a healthy state after she finally had her breast implants removed a year and eight months ago with a procedure commonly called, “ex-plant” surgery.

“That’s what we’re trying to do, hold the FDA accountable. They’re supposed to protect us,” Diaz said.

Last summer, 9 Investigates first reported about women blaming their implants for unexplained illnesses.

At the time, nearly 20,000 women were discussing the problem in a Facebook group. There are now more than 50,000 in that group.

Diaz also formed a Facebook group specifically for Florida women. It has the attention of nearly 2,000 implant patients.

Dr. Marguerite Barnett has a six-month waiting list for women who want their implants removed, and has expressed frustration with the FDA for not setting up a registry promised to track the implants.

“We have no idea of the failure rate, other than what the manufacturers choose to report,” Barnett said. It’s sad that we’re lacking all of this basic data.

The FDA granted pre-market approval to two breast implant manufacturers in 1996, expanding marketing of implants, but both companies were required to perform post studies to monitor safety and effectiveness.

Dr. Barnett says some of her patients never received proper follow-up care.

And although manufacturers do provide warnings about the health risks that can be associated with the class three medical devices, there are questions about whether patients are getting the message.

“So much of it is in technical terms, I think we really have failed to give really good informed consent,” Barnett said.

One of the implant manufactures told 9 Investigates in a statement they are partnering with groups to develop that breast implant registry — to better understand the cause the cause, incidence and potential risk factors associated with that rare form of cancer–no mention of other illnesses.

The FDA did not commit to any changes during the meeting, but told us 9 Investigates that they continue work to develop that registry.

The women in that meeting said they feel the FDA is strongly considering an Advisory Committee Panel meeting on breast implant issues.

Read the original article here.

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. […]

“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. […]

Both women say they went to doctors who couldn’t figure out what was wrong, all while new symptoms were developing. […] and after doing some research found a Facebook group of 35,000 women, all claiming similar symptoms.

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. […]

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.

Breast Implants Causing Cancer

WJMN Local 3 News: September 8, 2017.

Stacey Boone says she was trying to boost her self-esteem, and wound up fighting for her life.

Boone says, “It was, how I wanted to feel about myself.”

She had no idea hew new beast implants would nearly kill her.

Boone says, “I came close three different times to dying. It started metastasizing to my bones and it metastasized to my liver, my liver had shut down.”

Stacey says doctors determined the plastic from her textured implant caused breast implant-associated lymphoma. The symptoms include lumps or hardening of the implant and fluid behind the implant.

Dr. Frederick Locke, medical oncologist, Moffitt Cancer Center says, “The symptoms often come on years after the breast implants are surgically placed.”

Dr. Locke says recent FDA warnings show there have been 359 breast implant-associated lymphoma cases reported. Nine deaths have been documented.

Dr. Locke says, “When the FDA looked at whether it was associated with silicone or saline implants there wasn’t much of a difference.”

But the difference in these cases? 90% had textured implants, just like Boone. Locke says breast implant-associated lymphoma can affect 1-in-30,000 women. […]

Read the original article here.

Woman with Rare Cancer Linked to Breast Implants Seeks to Spread Awareness

CBS NewsJuly 13, 2017.

[…] The American Society of Plastic Surgeons says around 550,000 women last year received breast implants, but the FDA published a report this year linking a rare cancer to the implants.

So far, there have been 359 reported cases globally, including nine deaths.

The risk is low, but one in 30,000 women with implants could develop it, including one patient who says she is battling the disease and her insurance company, reports CBS News correspondent Anna Werner.

Kimra Rogers was shocked to find a tumor under her arm. […]

Then she learned it was cancer, possibly connected to the cosmetic breast implants she’d had put in 17 years ago. […]

It’s called breast implant-associated anaplastic large-cell lymphoma, a rare cancer the FDA says can develop following breast implants, something doctors at MD Anderson Cancer Center in Houston have been studying for five years.

“This is a type of lymphoma. It is not a breast cancer. It’s actually a cancer that develops in the scar tissue around a breast implant,” said Dr. Mark Clemens. […]

But insurance companies don’t always agree to pay. Rogers says her insurer, Blue Cross Blue Shield of Montana, denied payment for removal of her implants three times, telling her it was a contract exclusion because her implants were cosmetic. […]

But Dr. Clemens said, “We can’t wait months or years till an insurance company say, ‘okay, we’re gonna cover it.'” […]

But if you notice any changes in the implants or your breasts, such as swelling, head to your doctor’s office as soon as possible to have any problems checked out.

Read the original article here.

A Shocking Diagnosis: Breast Implants “Gave Me Cancer”

Denise Grady, The New York Times: May 14, 2017.

Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.

In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest. […]

Her disease — breast implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants.  […]

The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling […] An F.D.A. update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the F.D.A.’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease. […]

As late as 2015, only about 30 percent of plastic surgeons were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston. […]

Diagnosis and Treatment

Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants. […]

Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy. […]

Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit. […]

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted […]

Read the original article here.

After Mastectomies, an Unexpected Blow: Numb New Breasts

Roni Caryn Rabin, The New York Times: January 29, 2017.

After learning she had a high genetic risk for breast cancer, Dane’e McCree, like a growing number of women, decided to have her breasts removed. Her doctor assured her that reconstructive surgery would spare her nipples and leave her with natural-looking breasts.

It did. But while Ms. McCree’s rebuilt chest may resemble natural breasts, it is now completely numb. Her nipples lack any feeling. She cannot sense the slightest touch of her breasts, perceive warmth or cold, feel an itch if she has a rash or pain if she bangs into a door.

And no one warned her.

“I can’t even feel it when my kids hug me,” said Ms. McCree, 31, a store manager in Grand Junction, Colo., who is raising two daughters on her own.

Plastic surgeons performed more than 106,000 breast reconstructions in 2015, up 35 percent from 2000. And they have embraced cutting-edge techniques to improve the appearance of reconstructed breasts and give them a more natural “look and feel” — using a woman’s belly fat to create the new breast, sparing the nipple, minimizing scarring with creative incisions and offering enhancements like larger, firmer lifted breasts.

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