Category Archives: Policy

NCHR Statement on FDA’s Request for Recall of Allergan Breast Implants and Expanders

Statement of Dr. Diana Zuckerman, President, National Center for Health Research on July 24 Announced Recall of Allergan Biocell Breast Implants and Expanders

h Research on July 24 Announced Recall of Allergan Biocell Breast Implants and Expanders

“The FDA announced today that at its request, Allergan is implementing a worldwide recall of their Biocell textured breast implants and expanders.  This recall is an important step toward reducing the risk of a type of cancer of the immune system called Anaplastic Large Cell Lymphoma (ALCL) caused by breast implants.  Many other countries had already banned this type of Allergan textured breast implant, but the FDA had previously stated that such a ban was premature.  However, it was inevitable that either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so.  It is a little surprising that the FDA is taking credit for the recall, since most recalls of medical devices are described by the companies as voluntary.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma.  This recall will reduce that risk but it won’t eliminate it.”

For more information, see the FDA’s Press Release here.

The Breast Implant Working Group’s Breast Implant Black Box Warning and Patient Checklist

The Breast Implant Working Group’s Breast Implant Black Box Warning

This black box warning was developed by the Breast Implant Working Group, which consists of Dr. Diana Zuckerman (National Center for Health Research), Dr. Scot Glasberg (American Society of Plastic Surgeons), Dr, Alan Matarasso (also ASPS), Jamee Cook (Breast Implant Victim Advocacy), Raylene Hollrah (Just Call me Ray), and Karuna Jaggar (Breast Cancer Action).   As individuals, we are urging the FDA to include a black box warning about the risks of cancer and other serious health problems for women considering breast implants.

BLACK BOX WARNING: Breast implants can cause a type of cancer of the immune system called BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma).  People with silicone or saline breast implants have developed this rare disease, which can be deadly if not treated early. Almost all women who have developed BIA-ALCL have had textured breast implants or expanders at some point.

Several studies also suggest that women with breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases. Women with silicone gel or saline breast implants have reported symptoms that are sometimes serious, such as joint or muscle pain, fibromyalgia, mental confusion, and painful skin conditions.  Many of these symptoms improve partially or completely when their breast implants are removed and not replaced.

The Breast Implant Working Group’s Patient Informed Consent Checklist

This checklist was developed by the Breast Implant Working Group, which consists of Dr. Diana Zuckerman (National Center for Health Research), Dr. Scot Glasberg (American Society of Plastic Surgeons), Dr, Alan Matarasso (also ASPS), Jamee Cook (Breast Implant Victim Advocacy), Raylene Hollrah (Just Call me Ray), and Karuna Jaggar (Breast Cancer Action).  The checklist has been endorsed by their organizations, as a requirement to be read and signed by all potential breast implant patients.

See the checklist here or below:


The purpose of this checklist is to provide information for patients considering breast implants for augmentation or reconstruction, so that they can carefully weigh the risks and benefits of breast implants and make the decision that is right for them. The risks in this checklist are in addition to common surgical risks such as infection, necrosis (skin death), or problems with anesthesia.

After reviewing the Patient Information Booklet, please read and discuss the items in this checklist with your surgeon. You should not initial or sign the document, and should not undergo the procedure, if you do not understand each of the issues listed below.

How long do breast implants last? I understand that breast implants are not expected to last for the rest of my life.  Implants may rupture or leak at any time, and that is more likely the longer you have them.  In addition, it is likely that I will need other surgeries related to my breast implants over the course of my life.  If I am a cosmetic surgery patient, my health insurance policy may refuse to cover these surgeries. These additional surgeries and procedures can include implant removal with or without replacement, muscle and tissue repair, scar revisions, MRI diagnostic exams, or other procedures. I understand that undergoing multiple surgeries may increase my chances of permanent breast deformity.

Patient Initials____________

Who shouldn’t get breast implants?  I understand that the safety of breast implants was never studied for people who have autoimmune symptoms or diseases, or a family history of those diseases. Breast implants may be more likely to cause serious health problems and symptoms for these people.  In addition, breast implants may not be safe for anyone with a weakened immune system or certain genetic risk factors that have not yet been identified.

Patient Initials____________

Chemicals and Metals in Breast Implants:  I understand that all breast implants contain chemicals and small amounts of heavy metals that may cause health problems. I understand that most of these chemicals are confined to the shell of the implant or stay inside the shell.  However, small quantities have been found to diffuse (bleed) from or through the implant shell, even if the implant is intact and not ruptured.

Patient Initials____________

Rupture and Leakage:  I understand that the longer my breast implants are in place, the more likely they are to rupture, especially after the first few years. When a saline implant ruptures, it usually deflates quickly. When a silicone gel implant ruptures, I may not notice any changes and the rupture may not be detected by my doctor or by mammogram, MRI, or sonogram. I understand that an MRI is recommended for silicone gel breast implants 3 years following surgery and every 2 years after that to check for silent rupture, and that these MRIs often are not covered by health insurance. I understand that silicone may migrate from the implant into nearby tissues such as the chest wall, lymph nodes, upper abdominal wall, and into organs such as the liver or lungs where it cannot be removed. Since migrated silicone can cause health problems, it is currently recommended that any ruptured silicone implant should be removed as soon as possible. I understand that, if needed, treatment of these conditions may be at my own expense and not covered by insurance or a manufacturer warranty.

Patient Initials____________

BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma):  I understand that there is a small risk for me to develop BIA-ALCL, a cancer of the immune system. BIA-ALCL is a type of lymphoma that develops on or around the scar capsule that surrounds the breast implant. I understand that the symptoms of BIA-ALCL include breast swelling, lumps, pain, and asymmetry that develop after surgical incisions are completely healed, usually years after implant surgery.

Treatment for BIA-ALCL includes removal of the implant and scar capsule, and, if not treated early, may include chemotherapy and radiation. This diagnosis and treatment may be at my own expense and is not always covered by insurance.

Patient Initials________________

Symptoms of “Breast Implant Illness:” I understand that because of the lack of long-term safety data, we are still learning about the health problems that result from breast implants.  To date, thousands of women have reported to the FDA or to researchers that they have experienced serious health problems that several studies have linked to their breast implants. This may occur either immediately after getting implants or years later. These often include symptoms such as: joint and muscle pain or weakness, memory and concentration problems, chronic pain, depression, fatigue, chronic flu-like symptoms, migraines, or rashes and skin problems.

Several studies of women with breast implants have shown that they are significantly more likely to be diagnosed with one or more of the following diseases compared to other women: • Chronic Fatigue Syndrome • Multiple Sclerosis (MS) • Rheumatoid Arthritis (RA) • Sjögren’s syndrome  • Systemic Sclerosis/Scleroderma

Although women who develop these symptoms or diseases can’t be certain that they were caused by breast implants, several studies indicate that most symptoms improve partially or completely after having their implants and capsules removed.

Patient Initials____________

Capsular Contracture:  I understand that one of the most common complications of breast implants is when the scar tissue capsule that forms around the implant hardens. In some cases, this can be quite painful, distort the shape of the breast, and can make mammography more painful and less accurate. Removing the implant and capsule without replacing the implant is the only recommended way to guarantee that this problem is corrected.

Patient Initials____________

Breast Cancer:  I understand that all breast implants can interfere with mammography and breast exams, possibly delaying the diagnosis of breast cancer. I understand that if I get breast implants, I should inform the mammography technologist about the implants and ask for additional views to improve the accuracy. I understand that mammography can also cause the breast implant to rupture or leak.

Patient Initials____________

Interference with Breastfeeding:  I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.  No long-term research has been conducted to determine the possible transmission of chemicals and heavy metals in the breast milk of women with implants.

Patient Initials____________

Loss of Sensation to Breast or Nipple(s): I understand that breast implants and breast surgery may cause the nipple or breast to be painful, or to have decreased sensation. These changes may be temporary or permanent, and may affect sexual response or the ability to nurse a baby.

Patient Initials____________

Cosmetic Complications:  Asymmetry, Implant Displacement, Ptosis I understand that if my breasts had slightly different shapes before surgery, they may remain slightly different after surgery. I understand that the implants may cause the breasts to look slightly different in size or shape. I understand that the implant may move from the original placement location and that may result in asymmetry or other cosmetic problems. Breast implants can cause the breasts to sag over time due to the weight of the implants. I understand that if I am not happy with the results, I may need future surgeries to improve the appearance of my breasts.

Patient Initials____________


Patient: I acknowledge that I have received and read the Breast Implant Patient Information Booklet and this checklist. I have had time to discuss the information in both with my doctor, and understand the benefits and risks of the implants and surgery.

______________________________________________Patient Signature & Date

Physician: I acknowledge that I have discussed the benefits and risks of breast implants as described in the Breast Implant Patient Information Booklet and this checklist. I have encouraged the patient to ask questions, and answered all questions accurately.

____________________________________________Physician Signature & Date

NCHR Letter Concerning Lead in DC Public School Playground

National Center for Health Research: May 2, 2019

Paul Kihn
Acting Deputy Mayor for Education, Washington, DC
1350 Pennsylvania Avenue, NW, Suite 307
Washington, DC 20004

Dr. Lewis Ferebee
District of Columbia Public Schools
1200 First Street, NE,
Washington, DC 20002


Dear Mr. Kihn and Dr. Ferebee:

I am writing on behalf of the National Center for Health Research (NCHR) to express strong concerns about the report released today that demonstrates high levels of lead in the rubber shred from the playground at Janney Elementary School in Northwest.

NCHR is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety.  We do not accept funding from companies that make products that are the subject of our work.

The new report, which used independent professional laboratories to evaluate the components that are visible in breaks in the playground at Janney, found that 8 of the 34 samples (24%) had levels of lead that were over 1,951 ppm. The highest level of lead found was over 59,000 ppm. We can compare this to EPA’s standard for lead in soil in a playground, which is 400 ppm and the Consumer Product Safety Commission’s standard for lead in consumer products intended for children is 100 ppm in all accessible parts.

At Janney, the average lead for all samples, including the samples with low levels of lead, was 2,417 ppm, which is more than 7 to 19 times the EPA and CPSC standards, respectively.

These very high levels are of great concern because children are being exposed in 3 ways:

  1. When they play on the playground, breathing in the lead dust;
  2. When their skin or clothes come in contact with the rubber shred that is now on the surface rather than below the “poured in place” surface; and
  3. When they put pieces of shred, some of which are pretty colors, in their mouths.   Studies have shown that swallowed rubber shred that can apparently be digested and thereby expose the child to the lead.

These results were so frightening, that I included them in my testimony before the U.S. Consumer Product Safety Commission at their annual meeting yesterday.

Experts agree that there is no safe level of lead exposure. Children exposed to even low levels of lead can be harmed, including attention-related behavior problems and poorer cognitive abilities. It can also delay puberty, reduce growth, and may affect kidney function. Exposure as a child can lead to lifelong health effects.

We understand that the school system and government of the District of Columbia have many urgent issues, but since the dangers of lead are so well understood, surely lead in the playground requires your immediate attention.



Diana Zuckerman, PhD


  1. Ecology Center. Report on lead in PIP playground at Janney School. May 2, 2019.
  2. Environmental Protection Agency. Hazard standards for lead in paint, dust and soil (TSCA Section 403). Updated 2018.
  3. Consumer Product Safety Commission. Total lead content business guidance & small entity compliance guide.–Manufacturing/Business-Education/Lead/Total-Lead-Content-Business-Guidance-and-Small-Entity-Compliance-Guide


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

Cancer Prevention and Treatment Funds’ Comments On USPSTF Draft Recommendation Statement for BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing

March 18th, 2019

We are pleased to have the opportunity to express our strong concerns about the draft recommendations for risk assessment, genetic counselling, and genetic testing for BRCA-related breast cancer. The Cancer Prevention and Treatment Fund is a nonprofit program that conducts, analyzes, and reviews research, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from pharmaceutical companies and have no financial ties to this issue.

We have concerns about the familial risk prediction methods and the baseline mutation probability threshold being used to refer large numbers of women for genetic counselling and potentially genetic testing.

According to the CDC[1], 1 in 40 Ashkenazi Jewish women have the BRCA mutation. Based on most of these models, most 30-year-old Jewish women with any first- or second-degree family history of breast cancer would likely be referred for genetic counseling, and yet 90% will not have a BRCA mutation.  This will clearly raise anxiety levels and we question whether the benefits outweigh those concerns.

Studies have shown that applying a seemingly universal mutation probability threshold of 10% for almost all risk prediction models will lead to a phenomenon called ‘over-dispersion.’  This means that those who are most likely to be carriers will have a very high probability prediction and those who are least likely to be carriers will have very low probability estimation.[2] Statistically, this often provides misleading and conflicting results to physicians.

Additionally, further research on the validation of risk prediction models has shown that the decision threshold should be derived from “diagnostic accuracy measures rather than defined directly by any breast cancer risk.”[3] Science has shown that tests in clinical settings with a high sensitivity are more likely to detect a higher number of carriers ultimately reducing the burden of unnecessary medical expense.3

Therefore, we urge the USPSTF to reconsider its assessment of the risk prediction models by employing a universal standardized sensitivity threshold instead of a universal standard mutation probability threshold. A universal sensitivity for all predication models will yield varying but statistically relevant mutation thresholds for different models. This will more accurately identify mutation carriers in need of genetic counselling and reduce the overall number of non-carriers who are sent for genetic counselling.

For questions or more information, please contact Dr.Varuna Srinivasan, MBBS, MPH at

[1] Center for Disease Control and Prevention,  Jewish Women and BRCA Gene Mutations,,, November 5th 2018

[2] Lindor, N. M., Lindor, R. A., Apicella, C., Dowty, J. G., Ashley, A., Hunt, K., Mincey, B. A., Wilson, M., Smith, M. C., … Hopper, J. L. (2007). Predicting BRCA1 and BRCA2 gene mutation carriers: comparison of LAMBDA, BRCAPRO, Myriad II, and modified Couch models. Familial cancer, 6(4), 473-82.

[3] Schneegans, S. M., Rosenberger, A., Engel, U., Sander, M., Emons, G., & Shoukier, M. (2011). Validation of three BRCA1/2 mutation-carrier probability models Myriad, BRCAPRO and BOADICEA in a population-based series of 183 German families. Familial cancer, 11(2), 181-8.

NCHR Comment on Management of Cybersecurity in Medical Devices

National Center for Health Research, March 18, 2019

National Center for Health Research Public Common on
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Thank you for the opportunity to provide our views on the draft guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”

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.  We do not accept funding from companies that make products that are the subject of our work.

We support FDA’s efforts to update their approach to address growing concerns about cybersecurity risks in medical devices through the premarket submission process.  Software and medical devices have become increasingly interconnected and vulnerable to network-related cybersecurity breaches, which puts patients at risk.  We have several concerns and recommendations to improve the updated guidance.

Justify the intended users, purpose, and value of the Cybersecurity Bill of Materials (CBOM).  The CBOM is defined as “including but not limited to a list of commercial, open source, and off-the-shelf software and hardware components to enable device users (including patients, providers, and healthcare delivery organizations)…to effectively manage their assets, to understand the potential impact of identified vulnerabilities to the device (and the connected system), and to deploy countermeasures to maintain the device’s essential performance.”  We agree that a CBOM that lists device hardware and software that could be vulnerable to cybersecurity breaches will be valuable going forward.  However, the guidance should also more clearly justify the CBOM intended users, purpose, and value:

  • How will the CBOM be helpful to the aforementioned users (particularly patients and providers) who may not have the required technical expertise to leverage this information to better manage their cybersecurity risks?
  • What are potential uses (and users) of the machine-readable format of the CBOM (described in Section B.1.g)? If this includes integration into FDA’s existing medical device databases or with ongoing (or planned) post-market surveillance initiatives, those should be mentioned.

 Explain how digital health cybersecurity that impacts medical devices will be addressed.  In the current document, one of the key criteria that places a medical device in the “higher cybersecurity risk” tier is its ability to connect with “another medical or non-medical product, or to a network, or to the Internet.”  However, many digital health technologies (e.g. clinical decision support, mobile apps, and electronic health records) are already capable of connecting and interacting with networks, as well as with other medical devices.  While recent legislation removed some digital health products from FDA regulatory oversight, cybersecurity attacks make no distinction between these different technologies, all of which play a potential role in patient care or clinical decision-making.1  As a result, guidance should explain how to handle cybersecurity attacks that target medical devices directly as well as indirectly through digital health technologies that could connect to these devices.  If the FDA plans to address digital health cybersecurity through the FDA Software Precertification program or other related initiatives, this should also be included in the guidance document.

Reinforce medical device cybersecurity without sacrificing usability.  The previous (2014) version of the draft guidance stated that “manufacturers should also carefully consider the balance between cybersecurity safeguards and the usability of the device in its intended environment of use,” yet the current draft completely removes the discussion of usability.  Cybersecurity and usability in medical devices are not mutually exclusive.  Indeed, poor product usability is a key problem in healthcare technology today, a source of frustration for healthcare providers, and also has important patient safety implications.2  We therefore strongly recommend reintroducing the usability discussion into the guidance document.



1         Ronquillo JG, Zuckerman DM.  Software-related recalls of health information technology and other medical devices: Implications for FDA regulation of digital health. Milbank Quarterly. 2017. 95:535–53.

2         Ratwani R, Benda N, Hettinger A, et al. Electronic health record vendor adherence to usability certification requirements and testing standards. JAMA. 2015. 314:1070–1.



NCHR Testimony on the Evaluation for High-Risk HPV Detection Devices

Dr. Varuna Srinivasan, MBBS, MPH, National Center for Health Research, March 8th 2019

Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan. I am a physician with a Master of Public Health from Johns Hopkins University. I am a Senior Fellow at the National Center for Health Research, which analyzes scientific and medical data to provide objective health information to patients, health professionals, and policymakers.

We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

  1. We would like to start by saying that we agree with the FDA’s evaluation that a clinical endpoint of CIN3+ for a HrHPV test is more meaningful in assessing pre-cancerous lesions. We agree that although the prevalence of these lesions is seen in fewer numbers in the population, recruiting more women for evaluation studies to detect CIN3+ will help maximize resources and prevent overtreatment in the future.  For these reasons, the National Center for Health Research encourages the panel to consider the presence of CIN3+ alone as a positive result and not the combination of CIN2+/CIN3+.
  2. We disagree with the proposed indications for use. As the FDA pointed out, 90% of all HPV clears on its own.  On average, women over 30 tend to have fewer sexual partners and more monogamous relationships than women under 30, and women over 65 have even fewer. That is why the USPSTF recommends co-testing or Pap smears every 5 years for women under 30 years of age.  The FDA proposal to screen all women from 25-60 with the HrHPV test exposes a large population of women to this test unnecessarily.  For that reason, we believe that HR HPV testing should be recommended only for women over the age of 30.1

It is important to keep in mind that Pap smears directly determine the presence of cancerous or precancerous cells in your body. Co-testing can provide the added benefit of identifying high-risk HPV infection and allow for more vigilant follow-up if HPV-16 or HPV-18 is diagnosed.

We respectfully urge the panel today to consider these suggestions while providing their final recommendations.

Thank you.

1 Varuna Srinivasan, MBBS, MPH, Jared Hirschfield, National Center for Health Research. Cervical Cancer Screening Options: What Is Best For You?

The advisory committee panel deliberated and provided input on specific questions prepared by the FDA to discuss new approaches to the development and evaluation of HR HPV devices. The FDA 24 Hour summary provides information on the topics and questions discussed during this meeting and can be found here

NCHR Statement to the Maryland State House Environmental Committee, Artificial Turf

National Center for Health Research, March 1, 2019.

Good afternoon. Thank you for the opportunity to speak today in support of this legislation to restrict the disposal of synthetic turf and turf infill.

I’m Jack Mitchell, director of health policy for the National Center for Health Research. NCHR is a non-profit public health organization which analyzes medical and scientific information to better inform policymakers and the public. We also monitor health-related legislation and explain the implications for patients and consumers. We do not accept funding from any company that makes products we evaluate, so I have no conflicts of interest.

Our organization has been testifying and writing about the dangers of synthetic turf for several years, and we’ve testified before state and local legislative bodies and federal agencies. Our staff has reviewed all publicly available scientific studies pertaining to the health impact of the toxic chemicals which are used in the manufacture of synthetic turf. We’re very concerned about it, and that’s why I’m here today.

Plastic and synthetic rubber are made with different types of hormone-disrupting chemicals, some of which are known to be particularly harmful to growing children. Scientists at NIH have concluded that these chemicals can be threats to health even at low levels. And 20% of the 96 chemicals taken from samples at five different synthetic turf companies were classified as probable carcinogens, according to a 2015 study by Yale University.

Contrary to what is often stated by industry supporters and manufacturers, synthetic turf has not been declared safe by federal authorities. In fact, the EPA and the federal Consumer Product Safety Commission are jointly studying the chemicals used in these products and have not yet finished their analyses. Unfortunately, there are no federal requirements for safety testing of these synthetic turf products before they are sold.

Since independent scientists are convinced that synthetic turf in playgrounds and parks is less safe than grass, the bill before you is especially important. Dumping these used synthetic turf products in unregulated locations, or worse, incinerating them, increases the dangers to all of us, and especially those living near such locations. Requiring a “chain of custody” of those who seek to dispose of these products, as this legislation outlines, is an excellent, common sense public health proposal and should be adopted.

Use of synthetic turf has exploded in recent years, and industry has stated there may be as
many as 12,000 of these fields and parks throughout the country. They each account for
hundreds of tons of construction-like and demolition debris, synthetic rubber and plastic waste, containing an array of toxic chemicals. Additional toxic materials are added every year to these fields, as rain washes some of it into our streams and lawns. These toxic materials belong in controlled waste facilities, not in undisclosed, unregulated dump sites where they can contaminate our air, water and soil.

Please pass this legislation and thank you for addressing this critical public health issue.

Please contact Jack Mitchell,, with any questions.

Is FDA Doing Enough to Make Sure Sunscreens are Safe?

Is FDA Doing Enough to Make Sure Sunscreens are Safe?
National Center for Health Research Statement in Response to FDA Proposed Regulations
February 22, 2019

 The National Center for Health Research (NCHR) supports the FDA’s proposed new regulations for over-the-counter (OTC) sunscreens. The proposed updates on how products are labeled should make it easier for consumers to identify key product and ingredient information.  Expanding the requirements for broad spectrum protection is an important safeguard, because it provides better protection against damaging UVA radiation.

FDA has found two ingredients commonly used in sunscreens, zinc oxide and titanium dioxide, to be GRASE (Generally Recognized as Safe and Effective) and found two others, . PABA and trolamine salicylate to be not GRASE. The latter two were previously removed from sunscreens so that decision has no impact.  We are disappointed that the FDA has not recognized a widely used sunscreen ingredient, oxybenzone, as unsafe.  Oxybenzone has been found to disrupt hormones, and could increase the risk of endometriosis in women, and alters sperm in animals.  For those reasons, NCHR recommended in 2016 that this ingredient be banned from sunscreen products.

FDA’s proposed rule admits that “there is potential for toxicity associated with the transdermal absorption and systemic availability of oxybenzone.”  However, the proposed regulation states that “This new information about absorption and potential safety risks is inadequate, by itself, to support an affirmative conclusion that products containing the active ingredients at issue are not safe”.  NCHR strongly encourages FDA to require research as soon as possible if the companies plan to continue using it.

Sunscreens are proven to prevent sunburn and since sunburn increases the risk of skin cancer, sunscreens are assumed to also reduce the risk of skin cancer.  Since that link isn’t proven, the role of FDA in ensuring these products are safe is absolutely essential.  As we did in 2016, NCHR strongly urges that FDA expedite the adoption of the proposed rule’s safety and efficacy measures for sunscreens, and immediately require research on other sunscreen ingredients for which the agency has insufficient information.

If you have any questions, please contact Jack Mitchell at

Cancer Prevention and Treatment Funds’ Comments On USPSTF Draft Recommendation Statement for Breast Cancer: Medication Use to Reduce Risk

February 11, 2019.

We are pleased to have the opportunity to express our strong concerns about the draft recommendations for the use of prophylactic hormonal treatments for women at increased risk for breast cancer.  The Cancer Prevention and Treatment Fund is a nonprofit program that conducts, analyzes, and reviews research, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers.  We do not accept funding from pharmaceutical companies and have no financial ties to this issue.

We have several concerns about the draft proposal and strongly urge USPSTF to reconsider the recommendation guidelines proposed for the following reasons:

  1. Most importantly, the evidence does not include information on absolute risk, which is much more meaningful to patients than relative risk.  The overall lifetime risk of breast cancer attributed to Tamoxifen would be reduced from 12% to 8%[i],[ii] if tamoxifen is taken over 5 years.  At the same time however, it would increase the lifetime risk of endometrial cancer from 3% to 6.5%[iii],[ii] and the lifetime risk of thromboembolism from 20% to 39%.[iv] Similarly, raloxifene reduces the lifetime risk of breast cancer from 12% to 5%[i],[iii] but increases the risk of thromboembolism from 20% to 31%.[iv]  Aromatase inhibitors lower the absolute risk of breast cancer from 12% to 5%,[i],[ii] while the lifetime risk of venous thromboembolism increased from 20% to 25%4 and the average lifetime risk of stroke from 20% to 23% as well.[v]  The risk of fractures increases with AI and decreases with tamoxifen and raloxifene, but those comparisons are primarily based on x-rays and bone mineral density, rather than health outcomes of importance to patients, such as pain, other quality of life issues, or abilities regarding activities of daily living.[ii]  In summary, the increases in absolute risk for several serious outcomes are considerably higher than the decrease in absolute risk of breast cancer.
  2. The importance of shared decision-makingthat was included in 2013 is missing in 2019.  The 2013 USPSTF recommendations included “shared informed decision-making” but the 2019 draft recommends that doctors “offer to prescribe.”  Research shows that informative discussions have a significant impact on patients’ decisions; those who are better informed of their associated risks are less likely to take these hormonal drugs.[vi],[vii]  As noted above, this discussion should focus on absolute risks, not relative risks.  The 2019 draft guidelines recommend physicians “offer to prescribe” these drugs to women who are at high risk of breast cancer but at low risk for adverse events; the ambivalence over risk-benefit ratio that was included in the evidence review draft is not reflected in this wording.[ii]
  3. Another major concern is the definition of women at high risk of breast cancer.  Since the risk of breast cancer increases with age, most women over 65 with one or two other risk factors would be categorized by the NCI risk model as “high risk” because their risk would be above 1.7% in the following 5 years.[viii] In addition, the NCI risk model is based on certain characteristics, but not mitigating variables.  The USPSTF definition of high risk would expose many women who have a moderate to low increased risk of breast cancer to the many unpleasant and serious side effects of these drugs.  In 2013, the USPSTF referred to high risk of breast cancer as at least 3% over the next 5 years, and that is a much more appropriate definition.[ix]
  4. Impact of side effects on quality of life is not adequately considered. Studies have shown that women on tamoxifen have significanly increased rates of hot flashes, arthralgia, vaginal dryness, and sexual dysfunction.  For these reasons, high-risk women on tamoxifen were more likely to discontinue these drugs within 5 years due to adverse events when compared to women in the placebo group.[x]

In addition to the specific issues above, we strongly urge the USPSTF to consider its recommendations regarding hormonal treatments in the context of other factors that can decrease the risk of breast cancer.  Healthy habits such as a healthy weight, a diet low in red meat and alcohol, as well as regular exercise have been known to reduce the overall risk of breast cancer.  For example, a major prospective study looking at health outcomes in postmenopausal women found that women with the healthiest diets and the most exercise will decrease their lifetime risk of breast cancer from 12% to 9%.[xi]

As noted above, the risks of these drugs are likely to outweigh the benefits for most women.  The USPSTF key questions focus too heavily on benefits of these drugs and do not give sufficient consideration to risks.  They should be revised to better assess cancer risk, potential benefit, and potential harm.  Only the women at very high risk of breast cancer and low risk of endometrial cancer and vascular disease should consider them.  We strongly urge USPSTF to substantially change the recommendations in light of the absolute risks involved, and that doctors engage in shared decision-making discussions, considering these drugs only for their highest-risk patients, focused on those absolute risks, in order to ensure informed decisions.

For questions or more information, please contact Dr. Diana Zuckerman at


  1. NCHR calculated the absolute risk based on the statistics provided by the National Cancer Institute; National Cancer Institute. (2012). Breast Cancer Risk in American Women.
  2. NCHR calculated the absolute risk based on the statistics provided by the United States Preventative Services Task Force Draft Recommendation Statement. (2019). Breast Cancer: Medication Use to Reduce Risk.
  3. NCHR calculated the absolute risk based on the statistics provided by the National Cancer Institute. (2013). Uterine Cancer – Cancer Stat Facts.
  4. NCHR calculated the absolute risk based on the statistics provided by Bell EJ, Lutsey PL, et al. (2015). Lifetime Risk of Venous Thromboembolism in Two Cohort Studies. American Journal of Medicine.
  5. NCHR calculated the absolute risk based on the statistics provided by Seshadri S., & Wolf, P.A. (2007). Lifetime risk of stroke and dementia: current concepts, and estimates from the Framingham Study. The Lancet Neurology.
  6. Fagerlin A, Zikmund-Fisher BJ, et al. (2010). Women’s decisions regarding tamoxifen for breast cancer prevention: responses to a tailored decision aid. Breast Cancer Res. Treatment.
  7. Melnikow J, Paterniti D, et al. (2005). Preferences of Women Evaluating Risks of Tamoxifen (POWER) study of preferences for tamoxifen for breast cancer risk reduction. Cancer.
  8. National Cancer Institute. The Breast Cancer Risk Assessment tool.
  1. United States Preventative Services Task Force. (2013). Breast Cancer: Medications for Risk Reduction.
  1. Day, R. (2001). Quality of Life and Tamoxifen in a Breast Cancer Prevention Trial. Annals of the New York Academy of Sciences.
  2. Thomson, CA et al. (2014). Nutrition and Physical Activity Cancer Prevention Guidelines, Cancer Risk, and Mortality in the Women’s Health Initiative. Cancer Prevention Research.