Category Archives: Helpful Articles

Testimonies and Publications from the NCHR


The articles in this section focus on NCHR’s testimonies that have been presented at FDA meetings. If you want to learn more about the debate around breast implant safety click on a link to learn more.

2017

American Health Care Act

2016

FDA Approval of Mentor Implants

2013

FDA Approval of Natrelle 410 Implants

2012

Breast Implant Regulation In the U.S. and Europe

2011

FDA Hearing on Silicone Gel Breast Implants

Safety and Regulatory Update

FDA Review of Link Between Cancer and Breast Implants

2008

Informed Consent Critiques

2005

April

2003

FDA Hearing Silicone Gel Implants

FDA Hearing on Saline Breast Implants

1993

Congressional Presentation on the FDA’s Regulation of the Breast Implant Industry

An Association of Silicone-gel Breast Implant Rupture and Fibromyalgia

S. Lori Brown, H.J. Duggirala, and G. Pennello, Current Rheumatology Reports, Vol 4, No. 4, pgs 293-8: August 2002

Silicone-gel breast implant rupture is common. Silicone-gel from ruptured implants may escape the scar capsule that forms around breast implants and become “extracapsular silicone.” Our previously published study found that women with extracapsular silicone gel were at higher risk of reporting that they were diagnosed with fibromyalgia. There has been a limited number of studies addressing this association in the literature. Some studies addressing the issue of silicone breast implants and connective tissue disease specifically exclude patients with fibromyalgia from the sample or do not include the syndrome in the analysis. Case series describing fibromyalg ia in patients with implants have been published, but many of these papers lack information on extracapsular silicone and are not representative because the patients are typically from referral populations. In addition, most studies do not have control groups of women without implants for comparison or do not distinguish between saline and silicone implants. Additional observational studies of women from nonreferral populations are necessary to validate an association. These studies should provide information on how the rupture is diagnosed, state whether the rupture extended beyond the capsule, and provide an appropriate control group for comparison. The findings from such studies may be important to physicians as they describe potential risks associated with implants to their patients. These findings should also be important for regulatory decision making on silicone-gel breast implants.

Read the original article here.

Crystal Hefner Removes Breast Implants, Says They ‘Slowly Poisoned’ Her

Chloe Tejada, The Huffington Post CanadaJuly 21, 2016

Talk about horrifying.

On Tuesday, Crystal Hefner posted an update to her social media accounts, revealing to her fans that she removed her breast implants after they caused several major health problems and bad side effects.

In the photo, posted on her Instagram and Facebook pages, the 30-year-old Playboy model — who’s been married to Hugh Hefner since 2012 — is seen lying convalescing on a hospital chair, wearing a blue gown, a robe and a towel resting on her forehead — an IV line attached to her hand.

 “My Breast Implants Slowly Poisoned Me,” she titled her post.

“Intolerance to foods and beverages, unexplained back pain, constant neck and shoulder pain, cognitive dysfunction (brain fog, memory loss), stunted hair growth, incapacitating fatigue, burning bladder pain, low immunity, recurring infections and problems with my thyroid and adrenals,” she wrote.

Hefner went on to explain that symptoms started a few years ago but she ignored them, despite the fact that she was not feeling well.

“The aches, the bladder pain, brain fog, fatigue. I ignored it, labeling myself a hypochondriac, despite truly worrying that there was something wrong with me. I joked about losing my memory to age, and about getting ‘lazy.'”

As the negative side effects worsened, her work as a model and DJ suffered.

“I began to cancel appointments and shoots because everything exhausted me,” she said. “I’ve had days in 2016 when I couldn’t get out of bed. I’ve felt such despair knowing life was happening all around me but I couldn’t participate… the fatigue was so severe that I could barely leave the house or drive. I was afraid to get up there in front of a crowd and go blank with brain fog.” […]

After announcing that she had been diagnosed with Lyme Disease and toxic mold, commenters said her symptoms were similar to the effects of those suffering from Breast Implant Illness.

She became a patient at The Lu-Jean Feng Clinic in Ohio, where, after discussing it with Dr. Lu-Jean Feng, she had her implants removed.

“Instantly I noticed my neck and shoulder pain was gone and I could breathe much better,” she wrote about how she felt after the surgery. “I know I won’t feel 100% overnight. My implants took 8 years to make me this sick, so I know it will take time to feel better. I also have other illnesses to address, but with the toxic bags removed, my immune system can focus on what it needs to.” […]

Here’s to wishing Crystal a safe, and healthy recovery.

Read the original article here. 

Breast Implants in France to Carry Cancer Warning: Researchers Find a ‘Clearly Established Link’

Dana Dovey, Medical DailyMarch 18, 2015

Following France’s National Cancer Institute finding a “clearly established link” between breast implants and a specific type of cancer, the country will now order all breast implants to come with a cancer warning. This announcement came after 18 cases of anaplastic large cell lymphoma were directly linked to women with silicone breast implants since 2011.

Anaplastic large cell lymphoma (ALCL) is a type of non-Hodgkin’s lymphoma that affects the blood. The link between breast implants and this form of cancer is extremely rare, so French officials have urged women who already have the implants not to remove them, the Daily Mail reported. Given the severity of the cancer in the few women who do develop it, French officials felt it necessary to inform women of all the possible risks associated with the surgery.

ALCL is extremely rare, affecting around one to six in every three million women who undergo breast augmentation, Medical News Today reported. However, a study conducted by researchers from Cambridge University in the UK found that nearly all cases of ALCL in breasts occurred in patients who had undergone breast augmentation, suggesting a link between the two. Although it’s not clear why silicone breast implants can sometimes cause cancer, the Cambridge investigation did shed some light on the mystery.

“It’s becoming clear that implant-related ALCL is a distinct clinical entity in itself,” Dr. Suzanne Turner, lead researcher of the Cambridge study, told Medical News Today. “There are still unanswered questions and only by getting to the bottom of this very rare disease will we be able to find alternative ways to treat it.”

Breast implants are a very popular surgery, with Dr. Diana Zukerman, president of the National Center for Health Research, explaining that in 2013 alone 300,000 American women opted for the operation. Of these women, around 80 percent undergo breast enhancement for cosmetic reasons while a further 20 percent have breast implants following breast cancer.

This is far from the first time that breast implants have been implicated in causing a health hazard. In 2011, French firm PIP caused global hysteria when plastic surgeons reported an abnormal amount of the implants rupture, the Daily Mail reported. It was later found that the firm had been manufacturing these breast implants using industrial grade silicone intended for use in mattresses.

The implants were subsequently found faulty and banned from use. Women who had already received the implants were advised to have them removed, although European health officials found no medical or toxicological evidence to back this advice.

Read the original article here.

Experts Decry Tying Medical Research Funds to FDA Standards Changes


WASHINGTON—Moves in Congress to link billions of dollars in new medical research funding to revised standards for drug and medical-device approvals are troubling some public-health experts, who say the combination makes it too easy for lawmakers to support lower patient-safety standards.

These safety advocates say legislation to beef up research funding for the National Institutes of Health should be separated from product-approval changes at the Food and Drug Administration.

“This is the first time this has been done this way, and it’s a deal with the devil,” said Dr. David A. Kessler, onetime FDA commissioner during the 1990s under presidents of both parties. “It’s time to uncouple the promise of research funding from the requirement that FDA standards be lowered.”

The linkage was first made last July when the House passed a bill to ease FDA approvals of drugs and devices in ways broadly endorsed by the drug and device industry. That legislation carried a big infusion of cash for medical research—$8.75 billion for NIH and $550 million extra for the FDA, both over five years. The measure, called the 21st Century Cures Act, passed 344-77 with broad bipartisan support.

In the Senate, the leader of a parallel effort said he hopes to bring a package of 19 FDA and NIH bills to the floor soon—along with a separate measure on NIH funds. Sen. Lamar Alexander (R., Tenn.) chairman of the committee that approved the package, said finding the source of the funding is “the last remaining important issue” on the legislation, which he considers “the most important bill Congress considers this year.” […]

The new FDA commissioner, Dr. Robert M. Califf, said in a recent talk that “this legislation, if not carefully crafted, could pose significant risks for FDA and American patients…Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm,” he said.

Patient-advocacy groups like the National Center for Health Research and Public Citizen have said several bills now in Congress could jeopardize safety. […]

Read the original article here.

Complications of Saline Breast Implants

Elizabeth Nagelin-Anderson, MA and Diana Zuckerman, PhD, National Center for Health Research

What You Should Know Before You Decide on Reconstruction

How risky are breast implants? This is a controversial question, but implant manufacturers have done research showing that local complications, including pain, rupture, and the need for additional surgery, are very common within the first three years.

The FDA required breast implant manufacturers Mentor Corporation and Inamed Aesthetics (formerly called McGhan) to conduct research on the complications of saline breast implants for breast reconstruction and breast augmentation patients. The purpose of this research was to provide women with information so that they can make a more informed decision about whether or not they want saline breast implants. This information is supposed to be made available by plastic surgeons to all patients before they make their decision. The studies did not include diseases or conditions such as cancer, lupus, or fibromyalgia.

This issue brief is based on the FDA’s analyses of data collected by Mentor Corporation and Inamed Aesthetics. It is based on research, not opinion. The 3-year data were analyzed by the FDA in 2000 and the 5-year data were analyzed in 2002. This fact sheet is only about reconstruction patients.

Mentor Saline Implants

Mentor conducted a 5-year study on reconstruction patients. Unfortunately, so many women (almost 60%) dropped out of the study before the five years were completed, that the information is not reliable. For that reason, we are only providing the information collected during the first 3 years after getting implants, which included 78% of the patients.

Important Points from the Mentor Data

  • Most women can expect at least one complication within the first 3 years.
  • 40% of reconstruction patients can expect to have additional surgery within the first 3 years.

Mentor Reconstruction Patients 3-Year Complication Rate

Reconstruction patients experienced the following problems within the first 3 years of receiving their implants:

40% Needed another operation
30% Capsular contracture (hardening of breast)
28% Asymmetry (breasts look different from each other)
27% Implant removal
20% Wrinkled appearance of breast
17% Breast pain
9% Infection
9% Implant leaks/deflates
8% Irritation/inflammation
6% Delayed wound healing
6% Seroma (watery portion of blood collects around implant or incision)
5% Scarring complications
2% Extrusion (implant comes through the skin)
2% Necrosis (death of skin or tissue)
1% Hematoma (blood collects around implant)
1% Position of implant changes

Loss of nipple sensation is not listed since nipples are removed during mastectomy.

Only 78% of the reconstruction patients who originally enrolled in the study completed all 3 years. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher.1

Inamed Saline Implants

Inamed, formerly called McGhan, conducted a 5-year study on breast reconstruction patients. They collected information at the 3-year point from 71% of the reconstruction patients who originally enrolled in the study.

At the 5-year point they collected information from 57% of the reconstruction patients. This is a problem, since no information is available for 43% of the patients. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher, and the 3-year data are more reliable than the 5-year data.

Important Points from the Inamed Data

  • Most women can expect to experience at least one complication at some point within 5 years after implant surgery.
  • 40% of reconstruction patients can expect to have additional surgery within the first 5 years.

Inamed Reconstruction Patients 3-Year and 5-Year Complication Rates

Reconstruction patients experienced the following complications during the first three years and first five years after surgery.

3 Year 5 Year
39% 45% Needed another operation
33% 39% Asymmetry (breasts look different from each other)
25% 36% Capsular contracture (hardening of breast)
23% 28% Implant replacement/removal – any reason
20% 27% Implant can be felt or seen
23% 25% Wrinkled appearance of breast
15% 18% Breast pain
12% 17% Implant is in a bad position
6% 8% Implants leaks/deflates
7% 7% Irritation/inflammation
6% 6% Intense skin sensation
6% 6% Scarring complications
5% 6% Infection
5% 5% Calcium deposits form around implant
4% 4% Seroma (watery portion of blood collects around implant or incision)
4% 4% Skin/tissue necrosis (death of skin or tissue)
3% 3% Delayed wound healing
3% 3% Implant extrusion (implant comes through the skin)
3% 3% Skin Rash
1% 1% Hematoma (blood collects around the implant)

Loss of nipple sensation is not listed since nipples are removed during mastectomy.

Most complications for Inamed patients through the first 5 years are similar to those reported after the first 3 years. Since it is well known that some complications, such as rupture and capsular contracture, increase over time, women with complications were apparently more likely to leave the study than those who continued. Some of these women have left their plastic surgeons and could not be contacted.2

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

References

Calling for Informed Consent on Silicone Gel Implants or an End to Sales

Diana Zuckerman, PhD, MAMM: Women, Cancer, and Community, Point of View column: March 2001

When women are diagnosed with breast cancer, they may not realize that one of their reconstruction options, silicone gel-filled implants, has never been approved by the Food and Drug Administration (FDA) as safe and effective. In fact, most doctors and patients probably do not know that there are remarkably few published studies on the safety of silicone breast implants for mastectomy patients.

Our think tank, the National Center for Policy Research (CPR) for Women and Families, has called for a moratorium on the sale of silicone gel implants until the FDA can assure that all women considering the implants are fully informed of the risks and the alternatives.

Women were clearly unaware of the risks when implants, which were initially designed for breast augmentation, were first sold in the 1960s. Implants were completely unregulated; it was not until 1976 that a new law required that the FDA determine which medical devices were safe and effective. Other devices took priority, and the FDA did not require silicone gel implant manufacturers to submit safety data until 1991.

In 1992, the FDA concluded that the implant studies were too poorly designed to prove that implants were safe. The law mandates that manufacturers prove that a medical product is safe; lack of proof that a product is dangerous is not sufficient. Nevertheless, the FDA decided that breast implants fulfilled a “public health need” and therefore made an exception, banning their use for most augmentation but allowing their continued sale as part of large clinical trials on mastectomy patients, women with breast deformities, and women with broken gel implants. The implant manufacturers have been conducting these trials ever since. Eight years later, none of the results have been published in a peer-reviewed journal.

Ironically, although the “public health need” for silicone implants was based primarily on the desire to help mastectomy patients, there is still almost no research at all on the safety of reconstruction with either silicone or saline breast implants. Most published epidemiological implant studies excluded mastectomy patients or include them only as a small proportion of patients studied. In such studies, any problems experienced by breast cancer patients may not be statistically significant.

Of the few studies of mastectomy patients with gel implants, one conducted by implant maker McGhan Medical showed that one out of four women had at least one additional implant-related surgery within the first year, and one out of four had at least one implant removed within two years. Since this study was never published, the information is unavailable to most doctors and patients.

Last year, an FDA study reported that many women with silicone implants do not realize their implants are broken and leaking. Using Magnetic Resonance Imaging (MRI), researchers determined that almost half (48 percent) of women who had silicone implants for only six to 10 years, and 79 percent who had implants for 11 to 15 years, had at least one ruptured implant. These women were unaware of the rupture, however, and had not sought any medical care. Since this study excluded women who had already reported implant problems or removal, the actual breakage rate is even higher.

Unfortunately, silicone gel and liquid can be impossible to totally remove, and medical journals have documented serious health risks and fatalities when silicone migrates to vital organs. The FDA study also found that 21 percent of the women had silicone “migrating” away from the broken implant to other parts of their body.

In addition to the risks of broken and leaking silicone implants, there are documented risks of implants that are true for either saline-filled or silicone gel-filled implants. These risks include those associated with surgery, such as infection, hematoma (blood or tissue fluid collecting around an implant), and the risks of repeated surgery to remove or replace implants that cause problems, as well as the risk of capsular contracture, in which a capsule of scar tissue tightens around the implant, often causing hardness and pain. Breast implants can also obscure the view of a breast tumor in mammography, thus potentially delaying a diagnosis of breast cancer. Even with specially trained technicians, some tumors will be hidden by the implants.

The safety of silicone implants should have been studied before they were sold to more than a million women. Mastectomy patients who received gel implants since 1992 are officially part of a clinical trial, but the objectivity of the study has been questioned by patients such as Kim Hoffman. In 1998, while testifying before the Institute of Medicine, a congressionally funded nonprofit, Hoffman said her implant problems were not reported to those analyzing the data. Unfortunately, problems are analyzed only if they are reported by the physicians (and in the case of rupture, the implant must be removed and then examined and reported by the manufacturer.

Obviously, the doctors and implant makers have a financial incentive to help prove that patients are satisfied and that implants are safe and problem-free. Despite congressional requests, no safety studies of mastectomy patients have ever been conducted by the National Cancer Institute. But if Congress hears from constituents, those studies might finally be conducted.

If the federal government allows the continued sale of silicone gel-filled implants without requiring long-term safety data, I believe it needs to at least make sure that all information about the risks of silicone gel-filled implants is provided to women in a clearly written consumer brochure and patient consent form, well before they undergo surgery. (That’s what the FDA requires with the recently-approved RU-486.) The FDA owes it to breast cancer patients to provide them with the same safeguards, so women can make a choice based on what is known and unknown about the risks.

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

In FDA Files, Claims of Rush to Approve Devices

Gardiner Harris, New York Times: January 13, 2009

An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.

The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.

Nine agency scientists complained in May to Andrew C. von Eschenbach, the F.D.A. commissioner, and the agency began an internal review. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one. Last week, the scientists wrote a similar letter to President-elect Barack Obama’s transition team.

Agency documents that are part of the internal investigation, including e-mail messages, were provided to The New York Times. Details of the investigations have not previously been made public.

The documents show that front-line agency scientists, like many outside critics of the agency, believe that F.D.A. managers have become too lenient with the industry. In medical reviews and e-mail messages, the scientists criticize the process by which many medical devices gain approval without extensive testing. And in e-mail correspondence, they contend that an agency supervisor improperly forced them to alter reviews of the breast imaging device and others.

William McConagha, the agency’s assistant commissioner for integrity and accountability, said he was continuing to investigate the scientists’ claims. Mr. McConagha said that Dr. von Eschenbach had offered to meet with the nine scientists before Friday, his last day in office.

“We in the Office of Commissioner are extremely concerned about allegations like this,” Mr. McConagha said.

In the documents, Representative Christopher Shays, a Connecticut Republican who lost re-election in November, is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that is supposed to help radiologists detect breast tumors.

The device, the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, is used with screening equipment made by Fujifilm Medical Systems.

Fujifilm Medical is based in Stamford, Conn., the heart of Mr. Shays’s former district. In the documents, Mr. Shays is referred to as “Congressman Fuji.”

“I am the Fuji congressman because I represented that district,” Mr. Shays said in an interview Friday.

Mr. Shays said he had called the agency supervisor only to demand that the agency make a final decision, not that it approve the product.

He scoffed at suggestions in the documents that his call led the supervisor to overrule scientists and approve the device. “That would be idiotic for someone to approve something they don’t think should be approved,” he said.

A spokeswoman for Fujifilm Medical, Courtney A. Kraemer, said the company had called its “local Congressional offices to ask them to help us get clarification on the F.D.A. process.”

The dissenting scientists protested, according to the internal documents, that “iCAD never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all F.D.A. submissions.”

An internal review said the risks of the iCAD device include missed cancers, “unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation.”

Ken Ferry, iCAD’s chief executive, said, “We have done all the appropriate testing to get the product approved.”

Mr. Ferry said that F.D.A. scientists were increasingly asking for more rigorous testing of devices, and that his company complied with those demands.

Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it’s intolerable to the scientists who work there.” Ms. Zuckermen, a longtime critic of the agency’s device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.”

The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.

A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews.

According to internal documents, some scientists in the agency’s device division seem to agree with these critics. One extensive memorandum argued that F.D.A. managers had encouraged agency reviewers to use the abbreviated process even to approve devices that are so complex or novel that extensive clinical trials should be required.

For instance, Shina Systems, an Israeli company, applied for approval for AngioCt, a device that combines CT images with X-rays to help guide cardiac surgeons during angioplasty and stenting procedures. The company sought an abbreviated review, according to the documents.

An F.D.A. reviewer said the company should conduct a clinical trial to prove that the device works since it is novel and risky.

“Should the images be misleading,” Dr. Brian Lewis, an agency cardiologist, wrote in a memorandum, “F.D.A. could expect immediate misguidance of catheters and possibly puncture of coronary vessels or overaggressive, inappropriate or inadequate stent or balloon use.”

Nonetheless, an F.D.A. supervisor — after meeting with Shina representatives — pressed scientists to consider allowing an abbreviated review, according to the documents. The agency’s decision on the device is pending, according to the documents. Dr. John Smith, a lawyer for Shina, wrote in an e-mail message that he would not comment on “ongoing regulatory matters.”

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

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.

Read the original article here.

Angelina Jolie’s Decision

Diana Zuckerman, PhD, National Center for Health Research, Huffington Post: May 16, 2013

When I read about Angelina Jolie’s announcement this week, I cringed.

I have greatly admired her willingness to speak out on important issues over the years. Her public announcement about her mastectomies will certainly reassure some women that losing a breast to breast cancer isn’t quite as frightening as it had once seemed. But Ms. Jolie is a powerful role model to millions of women. What are the unintended consequences of the role she is modeling regarding breast cancer?

Is breast cancer so frightening that it is better for a woman to remove her breasts before she is even diagnosed? Obviously, that isn’t what Ms. Jolie is saying. She has one of the breast cancer genes (BRCA1), and that greatly increases her chances of getting breast cancer.

However, the extremely high risk that she quoted from her doctor (87 percent chance of getting breast cancer) was based on old, small studies. Newer studies have found that the risk of getting breast cancer for an average woman with BRCA1 is 65 percent. Since being overweight and smoking increase the risk and exercising and breastfeeding lower the risk, Ms. Jolie’s risk of breast cancer, even with the BRCA1 gene, could be considerably lower.

Of course, the lifetime risk of breast cancer would still be high, but it wouldn’t be nearly as high a risk during the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 16 percent chance of getting breast cancer before she turns 50. That’s not nearly as frightening, and with regular screening and all the progress in breast cancer treatments, the survival rate from breast cancer is higher than ever. Many breast cancer patients live long and healthy lives. And, it is possible that by the time Ms. Jolie (or any other woman with BRCA1) got breast cancer in the future–if she ever did–the treatments available would be even more effective than they are today.

Thanks to mammograms, women are getting diagnosed with breast cancer at much earlier stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). And yet, American women are undergoing mastectomies at a higher rate than women in other countries–many of them medically unnecessary. Breast cancer experts believe that many women undergoing mastectomies don’t need them and are getting them out of fear, not because of the real risks.

As an actress whose appeal has focused on her beauty, surgically removing both her breasts when she didn’t have cancer was a very gutsy thing to do. But if we care about women’s health, we need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.

Nobody can second-guess Angelina Jolie’s choice–it’s hers alone to make. Fortunately for her, she has access to the best reconstructive surgeons in the country, and they will keep her breasts looking as natural and beautiful as possible, an advantage that most implant patients don’t have. If she has any of the common problems with her breast implants, she can afford to get those problems surgically fixed whenever she wants to. She can also afford breast MRIs every other year ($2,000 each), which the Food and Drug Administration recommends as a way to make sure that the silicone from the implants is not leaking into the lymph nodes.

Angelina Jolie is not in any way an average woman, and what felt right for Angelina Jolie might not be right for most women who are afraid of getting breast cancer, and not even for most women with the BRCA1 or BRCA2 gene.

I thank Ms. Jolie for speaking up about her decision, and I thank the many cancer experts who are doing their best this week to explain why double mastectomies are not the best choice for most women. Let’s use this teachable moment to have a frank discussion of the treatment choices for breast cancer and to encourage women to make decisions based on their own situations, not on the choice of a celebrity, however admirable she is. For each woman, it’s important to weigh her own risk of cancer–in the next few years, and not just over her lifetime–and the risks of various treatments, and to make the decision that is best for her.

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