Tag Archives: breast implants

FDA Warns Allergan Over Breast Implant Studies

Sasha Chavkin, International Consortium of Investigative Journalists: May 19, 2020


United States health authorities issued a warning letter to leading global breast implant manufacturer Allergan for failing to properly carry out post-market safety studies.

The U.S. Food and Drug Administration found that Allergan did not meet its standards for recruiting and following up with participants in studies that included several styles of implants withdrawn from sale worldwide last year due to cancer risks.

Another company, Ideal Implant Incorporated, was rebuked for failing to properly track complaints by customers or take adequate corrective actions for problems identified during a site inspection.

“The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations,” Dr. Binita Ashar of the FDA’s Center for Devices and Radiological Health said in an agency statement announcing the warning letters.

In November 2018, the International Consortium of Investigative Journalists revealed that thousands of women around the world were suffering from serious illnesses after receiving breast implants, a finding that was part of its global Implant Files investigation.

In the months after the Implant Files’ publication, regulators around the world took action to better protect patients. Authorities in France, Canada, and the United States announced bans on Allergan Biocell implants, which were associated with increased risk of a rare form of cancer.

The moves prompted Allergan to announce a global recall of Biocell products last July. (Earlier this month, Allergan was acquired by global pharmaceutical giant AbbVie.)

The recalled implants are among the ones that Allergan was failing to properly study, the FDA found. The agency noted that the studies were crucial to identifying the risks for patients already implanted with Biocells.

“Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market,” Ashar said in the FDA’s statement.

The agency touted the warning letters as a part of its “ongoing efforts” to better protect breast implant patients, also citing its Medical Device Safety Action Plan and the development of a National Breast Implant Registry to collect data on breast implant safety.

But Dr. Diana Zuckerman, the director of the National Center for Health Research, a health policy think tank, said the agency must also be willing to take tough measures against companies that fail to follow its rules.

Zuckerman noted that breast implant makers have a history of poor compliance with safety studies mandated by the FDA, which approved silicone breast implants for the U.S. market in 2006 despite scant data on their long-term safety.

Instead, the agency allowed manufacturers Allergan and Mentor to conduct long-term safety studies after their products were already on the market. Within three years, Allergan and Mentor lost touch with 40% and 80% of the patients, respectively, in key sections of these post-approval studies, torpedoing the FDA’s demand that they collect reliable long-term data.

Nonetheless, the agency permitted the implants to remain on the market.

Zuckerman was skeptical that the warning letters would have much effect unless the FDA showed it was willing to take products that violated its rules for safety studies off the market.

“It absolutely should be possible to take off the ones that aren’t studied properly,” Zuckerman said. “I guarantee if they did that the ones that are still on the market would finish their studies.”

Read the full article here

‘They killed her’: Why are breast implants still putting millions of women at risk?

Maria Aspan, Fortune: May 18, 2020


Thirty-three years before her death, Paulette Parr visited her doctor for a popular and relatively routine procedure. It was 1986, and Parr was 35, working in human resources at the local hospital in Sikeston, a 16,000-person Missouri enclave midway between St. Louis and Memphis. A married mother of two young boys, she was interested in what plastic surgeons still call a “mommy makeover,” a catchall for the various procedures that nip, tuck, and lift women back to a pre-childbirth shape. For Parr, that meant getting her first set of breast implants.

For the next 15 years, through losing her first husband and remarrying and getting promoted to her hospital’s purchasing department, Parr was mostly happy with her implants, and with how they made her look and feel. But they were silicone-based, a type the U.S. Food and Drug Administration banned in 1992 over concerns that they were causing autoimmune and safety problems, and Parr eventually started to worry about them. So by 2002, when she learned that one of her implants had ruptured and was leaking silicone into her body, Parr’s surgeon replaced them with saline-filled versions. Her new Biocell implants were covered in a roughly textured silicone shell, designed to reduce movement of the device.

That’s when Parr’s implant-related health problems really began, according to a lawsuit her husband has filed against pharmaceutical company Allergan, the maker of Biocell products and one of three major manufacturers of American breast implants. In 2010, after one of her saline implants started leaking, her plastic surgeon replaced them with yet another set of Biocell textured implants, this time filled with silicone, which the FDA had allowed back onto the market in 2006.

“They were gorgeous, and they were put in by a reputable doctor,” says Paulette’s widower, Calvin Parr, months after her death. “We never gave it a second thought.”

Breast implants have long been a punch line, mocked as frivolous markers of female vanity. But that dismissive attitude overlooks a business with a serious and sometimes deadly impact on the health of its overwhelmingly female customer base. More than 8 million American women have undergone breast-related plastic surgeries since 2000; in 2018 alone, more than 400,000 women chose one for either cosmetic or reconstructive reasons. Breast augmentation is the most popular cosmetic procedure tracked by the American Society of Plastic Surgeons.

Many women, especially those affected by breast cancer, say they are grateful to have implants as an option. “It’s a decision that’s personal,” says Lynn Jeffers, the society’s current president, a plastic surgeon, and a cancer survivor who’s getting post-mastectomy reconstruction. “With the data that I have now, I’m comfortable having implants.”

And pharmaceutical companies have been very comfortable selling them, despite a long history of government recalls and product-liability lawsuits. Allergan, which was acquired by AbbVie in May, sold $399.5 million worth of implants in 2017, before regulators around the globe started banning some of its products. Its main rival, Johnson & Johnson, doesn’t break out results for its Mentor Worldwide breast implant business. Smaller specialist Sientra reported annual “breast products” revenues of $46.4 million in 2019.

Those numbers pale in comparison to blockbusters like Allergan bestseller Botox, which raked in $3.8 billion last year. But like Botox, breast implants can have attractive recurring revenue built in for manufacturers and the doctors who use their products. Even under ideal circumstances, breast implants “are not lifetime devices,” the FDA warns, and will likely need to be replaced every 10 to 15 years, for a cost of up to $12,000 per cosmetic procedure.

Yet as doctors, patients, lawyers, and public health experts tell Fortune, breast implants have remained on the market despite decades of inadequate testing and study, recurrent safety concerns, and poor regulatory oversight. Those problems plague many medical devices, which range from machines used outside the body to artificial parts implanted within it. But breast implants are unique in their affiliation with female sexuality and physical appearance, their intersecting roles as elective beauty products and clinical tools that can help cancer survivors feel more like themselves—and the degree to which patients’ mounting concerns about them have been dismissed for decades. Now, that accumulated failure of oversight has created sweeping, sometimes tragic crises for potentially millions of women.

“There are a lot of women who are really suffering,” says Diana Zuckerman, president of the National Center for Health Research. “You have these products that are widely, widely sold, and every few years we learn something new about the problems they cause.”

Breast implant makers walk a particularly fine line when it comes to creating a product that is both safe and “realistic.” Today’s implants are either filled with saline (more likely to break) or silicone (more natural looking and feeling but plagued by a history of safety concerns). Their exteriors can be either smooth or made of a “textured” silicone shell. Smooth implants are more popular in the U.S., but surgeons working with mastectomy patients sometimes prefer textured versions, because the products’ rougher surface enables tissue to grow onto the implant more easily.

All of these variations are prone to malfunctions or side effects, which can include ruptured implants; a buildup of scar tissue that can cause pain and tissue hardening; a large collection of symptoms often known as “breast implant illness,” which can include joint pain, migraines, and chronic fatigue; and, increasingly, a sometimes fatal cancer of the immune system known as ­BIA-ALCL, for “breast implant–­associated anaplastic large cell lymphoma.”

“The breast implants that are on the market right now all have issues,” says Madris Tomes, a former FDA manager who tracks reported medical device failures at her Device Events firm. “I wouldn’t recommend them to anyone that I care about.”

The causes of the various problems with breast implants are still poorly understood, which public health experts blame on a lack of testing or objective, long-term studies that do not rely on manufacturer-provided data or funding. Device makers also have yet to fully report the data the FDA required as a condition of allowing silicone implants back on the market in 2006.

[…]

Read the full article here

FDA considers black box warning for all breast implants

Mariel Carbone, WCPO Cincinnati: February 09, 2020


Although many other survivors choose implants after their mastectomies, [Lily McBreen is] adamant that she won’t. Having almost lost her life once, she’s worried the side effects of receiving breast implants could endanger it again.

[…]

“I wanted to avoid the rheumatological symptoms that have been out in the news for so many decades,” she said. “There has been so many accounts of women complaining of problems with them.”

Those symptoms, which women are calling “breast implant illness,” are among the many reasons the United States Food and Drug Administration could soon take extreme measures when it comes to educating the public about implants.

[…]

Currently, the black box warning exists only as a draft while the FDA continues to consider its implementation.

The draft warning outlines three main concerns.

First, “breast implants are not considered life time devices” and women may require more surgery if complications occur.

It also states that implants have been associated with BIA-ALCL.

[…]

Finally, it describes how some patients have reported a variety of symptoms, including “joint paint, muscle aches, confusion, chronic fatigue, autoimmune disease and others.”

The FDA is also proposing a patient decision checklist, which would include situations in which the device should not be used, considerations for a successful breast implant candidate, risks of surgery, the importance of using an appropriate physician, the risk of BIA-ALCL and other symptoms and discussion of other options.

Still, some have said these proposals don’t go far enough, including Diana Zuckerman who is President of the National Center for Health Research. The center initiated the Breast Implant Working Group, which is made up of six experts including patient advocates and plastic surgeons.

“The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients,” the working group said in a statement. “The FDA draft Black Box states that ‘breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’ Association implies correlation rather than causation. In fact, the evidence is clear that breast implants can cause BIA-ALCL.”

Read the original story here.

Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

Scot Glasberg, MD,  Diana Zuckerman, PhD,  Alan Matarasso, MD, Karuna Jagger, Raylene Hollrah, Jamee Cook, and Maria Gmitro, December 23, 2019


Download the comment here.

Comment to the FDA Docket on the FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

A Working Group comprised of two former presidents of the American Society of Plastic Surgeons, the president of a national research center, and four nationally respected patient advocates came together to find common ground regarding the risks of breast implants.   As individuals (Dr. Scot Glasberg, Dr. Alan Matarasso, Dr. Diana Zuckerman, Ms. Karuna Jagger, Ms. Raylene Hollrah, Ms. Jamee Cook, and Ms. Maria Gmitro), we are urging that the FDA require a black box warning and Patient Informed Consent Check List that provides information about the risks of cancer, breast implant illness, and other serious health problems in explicit and easy-to-understand wording that all individuals considering breast implants can understand, regardless of educational level or stress that is inevitable when a person  is considering surgery.

Black Box Warning

The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients.  For example, it should specify that breast implants can cause ALCL, breast implants are not lifetime devices (instead of FDA’s proposed Black Box wording that they are “not considered lifetime devices), replace technical jargon, and be more explicit about the evidence regarding breast implant illness instead of making it sound like it is not a real risk.

The FDA draft Black Box states that “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”  Association implies correlation rather than causation.  In fact, the evidence is clear that breast implants can cause BIA-ALCL.

The FDA draft says that the rates of BIA-ALCL “are not well defined.”  Although correct, that terminology will not be understood by all patients.  Instead, it should state that the rates “are not known.”

We agree with the FDA draft that it is important to illustrate the seriousness of BIA-ALCL by stating that “Some patients have died from BIA-ALCL.”

The draft Black Box wording regarding symptoms of breast implant illness would be confusing to patients.  It refers to systemic symptoms, which is the correct term, but not one that all patients would understand.  It does not mention breast implant illness, which although not an established medical term, is one that is well understood by patients.  The FDA draft background paper and Black Box warning both state that “some” patients with breast implants “have reported a variety of systemic symptoms,” which implies that the numbers of women with these symptoms is small and that they reported the symptoms but that they haven’t been diagnosed.  That is incorrect.  The wording should be changed to “patients have experienced a variety of symptoms.”  The FDA proposed Black Box statement that “some patients report complete resolution of symptoms” again implies that these improvements are reported but not medically confirmed.

On the contrary, a review of several well-designed studies by De Boer et al. (2017) found that most women with breast implant illness who had their implants removed and not replaced were confirmed by physicians to have complete or substantial improvement in their symptoms and overall health.

In addition, the FDA draft Black Box does not mention the risk of autoimmune/connective tissue diseases.  The Black Box should specify that “several studies suggest that women with silicone gel or saline-filled breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases.” That statement is supported by the largest long-term study to date, by Watad et al. (2018), a retrospective analysis of 24,651 women with breast implants (confirmed by medical records) and 98,604 matched women who did not have breast implants. The strongest association with breast implants (OR>1.5, p<0.001) was recorded for Sjögren’s syndrome, systemic sclerosis (scleroderma) and sarcoidosis, based on new medical diagnoses made after the women received breast implants, which were included in medical records during a period of up to 20 years.  In addition, (Coroneos et al. 2019) reported that Allergan’s study of 60% of the almost 50,000 women they enrolled in their study submitted to the FDA, physicians’ diagnoses of their patients two years after their implant surgery found statistically significant increases in fibromyalgia, rheumatoid arthritis, and lupus compared to the general population.  Although the Mentor data reported in that study are very flawed, the Allergan data, which were provided to the FDA, seem solid.

Patient Informed Consent Checklist

The Breast Implant Working Group created a checklist that was provided to the FDA in October.  This checklist has been endorsed by the American Society of Plastic Surgeons, the National Center for Health Research, Breast Cancer Action, Our Bodies Ourselves, National Women’s Health Network, Jacobs Institute for Women’s Health, Breast Implant Victims Advocacy, Just Call Me Ray, and Breast Implant Safety Alliance.  It was also supported by more than 77,000 individuals who signed a petition that the Working Group provided to FDA officials on December 9, 2019

We agree with the FDA that the purpose of a patient 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. Based on our experience with patients, we urge the FDA to ensure that the checklist is:

  • Brief and easy-to-understand, formatted with information on specific issues that are presented succinctly;
  • Jargon-free. Keep in mind that the average reading level in the U.S. is 6th
  • Organized to focus on the information that patients are less likely to obtain from other sources. It should not start with lengthy sections that are not especially interesting to patients.

Focus and Organization of the Checklist

The goal of the checklist should be to provide the most essential information that patients might not get from standard informed consent forms. It is therefore essential that the checklist provide information that thousands of implant patients have stated they were not warned about.  For that reason, the checklist should not focus on surgical and cosmetic risks, which are the types of risks that all patients are warned about in standard consent forms.  Instead of the almost full page of mostly surgical risks that are listed at the beginning of the FDA’s draft checklist, such risks should be summarized very briefly in one sentence, with the checklist focused on other risks that patients could otherwise not be aware of.  Similarly, cosmetic and local risks should be listed last in the checklist, since that information is more likely to be provided through other means.

The FDA draft checklist starts with “Considerations for a Candidate for Successful Breast Implantation,” cancer risk and a short section on “systemic illness.”  We suggest shorter, more focused headings and information to make the checklist more engaging and easy to read.

Who shouldn’t get breast implants?

The above heading should replace “Considerations for a Candidate for Successful Breast Implantation,’ since that latter heading implies that the patient characteristics listed are the only ones that would reduce the chances of complications or other problems.  In terms of content, the FDA draft wording on who should not get breast implants contains important information but is much too long and includes information that could be summarized.  The goal of the checklist should be to provide the most essential information that patients might not get from standard informed consent forms.  We recommend a short summary regarding active infections, cancer, or wound healing, and the following wording instead:

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.

Risk of Cancer: BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma)

We recommend that the FDA’s draft wording for BIA-ALCL could be improved as follows:

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. 

Systemic Symptoms:  Breast Implant Illness

As noted earlier, “Breast Implant Illness” should be the term used, since “systemic symptoms” is not a term that all patients would understand.  Also as noted earlier, the FDA draft guidance and draft checklist consistently imply that the number of women reporting symptoms of breast implant illness is small and that there is no research evidence that the symptoms are caused by their implants.  For example, the FDA’s draft wording that “some women report” implies that a small number of women are claiming an illness that isn’t real.  It is more accurate and meaningful to patients to say that several studies support the apparent causal link to breast implant illness symptoms (Watad et al 2017 and Colaris et al. 2017) and to symptom improvement after implants are removed (DeBoer et al. 2017), for example).  It should also state that the largest, long-term studies also indicate a statistically significant increase in certain autoimmune or connective tissue diseases, as summarized on page 2 of this document, citing Watad et al. 2018 and Coroneos et al. 2019). For that reason, ASPS, researchers, women’s health organizations, and patient groups endorse the following wording:

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; and 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.

Breast-Implant Specific Risks

This heading in the FDA’s draft Checklist is misleading, since BIA-ALCL and many other risks of breast implants are specific to breast implants.  More important, this section is much too long and includes too many topic areas.

We therefore recommend the following shorter, more specific sections:

How long do breast implants last?

It’s essential that patients understand what it means when experts say that breast implants “don’t last a lifetime.”  Since many implant patients are young, some think that means they only last 30-50 years.  Even saying “the longer you have them, the more likely they are to break” can be misinterpreted to refer to 30 or 40 years later.  For that reason, the Working Group Checklist specifies “Implants may rupture or leak at any time, and that is more likely the longer you have them” and that “it is likely that I will need other surgeries related to my breast implants over the course of my life.”

The wording should be succinct, explicit, and easy to understand.  Augmentation patients are already aware that their insurance policy does not cover cosmetic surgery, but it is important for them to also know that insurance is unlikely to cover subsequent surgeries due to complications or breakage, since they might mistakenly assume that problems related to implants will be covered even if the initial cosmetic surgery is not.  We recommend the following wording:

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 for removal, and probably would not cover replacement. 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.

Chemicals and Metals in Breast Implants

Patients should be informed about the chemicals and metals in the specific make and model of breast implants they are considering.  Since the checklist is for all breast implant patients, it should include a brief, general statement about chemicals and heavy metals, but each patient should get separate, more detailed information about the specific model of implant they are considering.  We recommend the following wording for the checklist:

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.

Rupture and Leakage

Patients would benefit from a section with a heading of “Rupture and Leakage.”  Although this overlaps with the issue of how long implants last, more specific information about silent rupture is important.  We recommend the following wording for the checklist, understanding that if FDA no longer recommends MRIs after 3 years, that wording should be revised, but the explicit information about the risks of silicone migration should be included:

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.

Capsular Contracture

Capsular Contracture is a common complication that therefore should have its own heading.  Our recommended wording is as follows:

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.

Breast Cancer

Breast cancer issues should be a separate heading in the checklist, not part of the section on ACLC, in order to avoid confusion.  Our recommended wording is as follows:

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.

Interference with Breastfeeding

Since the data are lacking, our recommended wording is as follows:

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.

Loss of Sensation to Breast or Nipple(s)

Many women do not understand that breast implant surgery can cause loss of sensation.  While more likely among reconstruction patients, it is important to note that augmentation patients can also experience loss of sensation or painful sensitivity.  We therefore recommend this wording:

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.

Cosmetic Complications

Cosmetic complications should be the last section of the checklist, because like surgical complications they are often included in standard informed consent documents.  We recommend the following brief, easy to understand, but explicit warnings, such as using the term “sag” instead of 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.

 

FOOTNOTES:

Colaris MJ, de Boer M, van der Hulst RR, Cohen Tervaert JW. (2017) Two hundred cases of ASIA syndrome following silicone implants: a comparative study of 30 years and a review of current literature. Immunologic Research 65(1):120-128. doi: 10.1007/s12026-016-8821-y

Coroneos C, Selber J, Offodile A, et al. (2019) US FDA breast implant postapproval studies: Long-term outcomes in 99,993 patients. Annals of Surgery 269(1):30-36. doi: 10.1097/SLA.0000000000002990

De Boer M, Colaris M, van der Hulst RR, Cohen Tervaert JW (2017) Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research 65(1):25-36. doi: 10.1007/s12026-016-8813-y

Watad A, Quaresma M, Brown S, et al (2017) Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome)—an update. Lupus 26(7):675-681. doi:10.1177/0961203316686406

Watad A, Rosenberg V, Tiasano S. et al. (2018) Silicone breast implants and the risk of autoimmune/rheumatic disorders: A real-world analysis. International Journal of Epidemiology. 47(6):1846-1854. doi: 10.1093/ije/dyy217

 

 

FDA Advisers Hear About Problems, Research Needs With Metal Implants

Mary Jo M. Dales, MedPage Today: November 14. 2019


Reports of adverse events related to metal-containing implants are on the rise. While still rare on a proportional basis, the numbers are increasing as the sheer volume of surgical implants has expanded, an FDA advisory committee was told Wednesday.

At the first day of a two-day meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee, members heard from experts that it isn’t easy to tease out which patients are likely to have an adverse event. While patients with a known metal allergy might be an obvious risk group, the ability to screen for these allergies is limited.

And while these devices each have a unique identifier, the metallic components within individual devices are seldom detailed in this labelling further limiting the patient’s ability to avoid a known metal allergy, based on public testimony given during the meeting. Over 50 registered speakers were granted speaking time at the two-day meeting.

In a discussion of an array of histologic, imaging, and serologic studies that might be useful for selected out patients at risk for metal-related adverse events, experts pointed out that these measures alone fell short. Abnormal test results do not reliably predict adverse events. Further, the combinations of tests that might be indicative would be prohibitively expensive to perform on a large population of patients to determine a small sub-population at risk.

As device implantation has grown in recent years, so have problems tied to them. In 2012, for instance, the FDA held a two-day advisory committee meeting to address failure rates and adverse effects from metal-on-metal hip implants. That led the agency a few months later to put restrictions on these products. Still, issues remain around management of patients who received them. And that’s just one type of metallic implant, of which there are hundreds if not thousands.

Earlier in 2019, the FDA announced efforts to further evaluate the safety of specific materials used in medical devices and how to better identify patients who might be at increased risk of experiencing a hypersensitivity response. The agency is accepting public comment on the issue until December 16.

[…]

In public testimony Wednesday, Karin Pacheco, MD, MSPH, an allergist at National Jewish Health and the University of Colorado in Denver, presented data on 1,500 patients with unexplained joint failure referred by their orthopedic surgeons who have ruled out infections and mechanical issues. The findings indicate that half of these patients are sensitized to something in the joint — about a quarter of them to the relevant metal in their implant, about 20% to bone cement, and a smaller proportion to both components.

Further, people with allergies and revised to another implant with different components do “extremely well,” she said. The implications are that sensitization to implant components is a cause of joint failure. “We think that nickel, cobalt and chromium, and maybe titanium, are the culprits, but we need more research.”

“If you have a history of skin reactivity [to device components], then you probably need to be tested” before receiving an implant, she said. Pacheco emphasized that over a million joint replacements are done each year in the U.S. and more of them are going to people ages 45-64.

Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, urged comparative effectiveness research.

“If certain implants seem to be causing certain reactions with certain kinds of patients, wouldn’t it be very important to know how that compares to other alternatives of the same kind of implants? We can’t treat all hip implants that are polyethylene and metal as if they’re all the same,” she said.

“We can’t treat all metal-on-metal implants as if they’re the same. We need to compare different models, different implants made in different ways with different materials by different companies and get some kind of real data” that patients and physicians can use to make informed decisions, Zuckerman added. Until then, figuring out how much is due to patient vulnerabilities and how much is the difference between various devices will remain challenging.

Several speakers detailed their personal experiences of adverse events, including neurologic and rheumatologic events that followed their receiving an implant. Linda Radach said she received a metal-on-metal hip implant requiring two subsequent revision surgeries, concluding, “The bottom line between all the harm is the materials. Go after that. Set rigid standards for biocompatibility testing.”

[…]

The Immunology Devices Panel will hear additional comments on Thursday, especially in regard to dental amalgam, and will respond to a series of questions posed by FDA staff.

Read the original story here.

When Recalls Fail: Many harmful products remain in homes and stores. Why that happens, what needs to change, and how to protect yourself.

Rachel Rabkin Peachman, Consumer Reports: October 31, 2019


Antibiotic-resistant strains of salmonella are linked to contaminated chicken, sickening many and hospitalizing more than 200 people for almost a year and a half, though it was known that the plants processing the chicken had failed federal food safety standards. Why did the outbreak go on for so long before the unsafe chicken was pulled from store shelves?

breast implant lacking premarket safety research is linked to a rare cancer, but years pass and women die before regulators acknowledge the connection and a manufacturer recalls the devices. Why did it take patient outcry before the potentially deadly implants were taken off the market?

An inclined sleeper for babies is put on the market without adequate safety testing or adherence to infant sleep guidelines. Over the next decade, as the sleeper becomes a best seller, dozens of babies die while using it. Why did it take public exposure before the manufacturer recalled the product?

In 21st century America, it’s easy to assume that the products we put on our plates, in our homes, and in our bodies are safe and effective. Many people expect that we have robust consumer protections in place—a system that vets products thoroughly before allowing them to be sold and that recalls products swiftly if they prove to be dangerous.

But product safety regulation and the recall process are part of a complicated and imperfect system that varies widely depending on the type of product, the industries involved, and the government agencies tasked with overseeing it. For instance, a recall does not get put into motion automatically when a product is known to cause harm. Recalls, if they happen at all, can take years to be initiated, often only after public protest and sometimes following injuries or deaths.

Moreover, when a recall is issued, consumers often aren’t made aware. Almost 70 percent of Americans said that they had not heard about a recall in the past five years for any product they own, according to a Consumer Reports nationally representative survey of 1,010 adults, though millions of products are recalled each year. And only 21 percent of Americans said they had heard about a recall and responded to it in that time frame. Of those, about two-thirds said the issue had to do with their car, 19 percent said it involved food, 9 percent a health product, and 9 percent a children’s product.

That disparity is not surprising, says David Friedman, CR’s vice president of advocacy and a former acting administrator of the National Highway Traffic Safety Administration. Unlike other federal agencies, NHTSA requires manufacturers to notify car owners directly about recalls. To track recalls, it helps that every car has a unique vehicle identification number and every owner has a registration. Other agencies—the Food and Drug Administration, the Department of Agriculture, and the Consumer Product Safety Commission—generally have fewer tools and requirements for recalls. In some cases, laws can actually shield agencies from accountability and protect companies from liability, Friedman says.

Even when consumers learn about a recall, they often aren’t given simple, effective ways to respond. Some entail disassembling and mailing in part of the product for a refund, or not using the product until a replacement part is mailed—a process that can take months. As a result, many recalled products remain in use, risking further injury.

How, then, can consumers ensure that the products they buy have been safety tested and have not caused problems since their release? In some cases, it’s impossible to fully know. But the examples described here provide a sense of how regulatory oversight sometimes works for—and against—consumers. Plus, we share steps you can take to protect yourself and your family.

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Dangerous Breast Implants

Raylene Hollrah was 33 years old in 2007 when she was diagnosed with breast cancer and underwent a mastectomy. A year and a half later, when she was ready for reconstructive surgery, she chose a silicone-filled implant with a textured surface made by Allergan. Hollrah, from Hermann, Mo., believed a selling point of the implant was that she’d automatically be enrolled in a 10-year study “so I could help other women,” she says.

What Hollrah didn’t know is that medical devices—including breast implants, artificial joints, and pacemakers—are subject to much less rigorous premarket testing than drugs are. That’s partly because the FDA didn’t begin regulating medical devices or requiring research on their efficacy and safety until 1976, after many devices were already in use.

Silicone breast implants were introduced in the 1960s with little to no safety research, says Diana Zuckerman, Ph.D., president of the National Center for Health Research. Even after the FDA began regulating them, the agency didn’t require premarket studies until 1991—when it determined there was insufficient safety research, and soon after put a moratorium on sales.

In 2006, when the FDA did approve silicone implants, it was on the condition that manufacturers conduct post-market studies, one of which included Hollrah. But that wasn’t made clear to her early on. And as time passed, more problems emerged. In 2011, the FDA announced a link between silicone- and saline-filled implants and a form of cancer called anaplastic large cell lymphoma (ALCL).

But Hollrah didn’t learn about breast implant associated ALCL, or BIA-ALCL, until 2013, when one of her implants swelled and she tested positive. “I removed breast cancer,” Hollrah says, “and then I put something right back in my body that gave me cancer again.”

Around the time of Hollrah’s diagnosis, Allergan dropped her from its post-approval study. In fact, Allergan lost track of many participants, in part because it was difficult to follow up with the women, who were given no real incentives to stay involved in the studies, Zuckerman says. As a result, the research was never completed. Yet the FDA did not penalize manufacturers or recall the implants.

Fortunately for Hollrah, her cancer was caught early. She had her implants removed in 2013 and is now cancer-free.

But it wasn’t until July 2019 that the FDA announced the recall of Allergan’s textured implants due to a reported worldwide total of 573 BIA-ALCL cases, 481 of them from Allergan, including 33 deaths.

When asked why it took eight years after the FDA acknowledged the risk of BIA-ALCL for the agency to request a recall, an FDA spokesperson said it took the action after learning, in the spring of 2019, of “a significant increase in known cases of BIA-ALCL.”

Though the recall is a victory for women affected by BIA-ALCL, other concerns remain. For one, “when medical devices are recalled, there’s typically not a rigorous process to reclaim the flawed products,” says Lisa McGiffert, a co-founder of the Patient Safety Action Network and a former patient-safety expert at CR.

There’s also no established system for device manufacturers to find and notify doctors and patients about a recall. Hollrah notes that she has yet to receive a recall notification from Allergan.

For its part, Allergan says that “patient safety is a priority” and that it is committed to ensuring the safe and effective use of its products.

Still, hundreds of thousands of women are estimated to have a recalled device in their bodies and no easy choices. The FDA recommends implant removal only for women with a diagnosis of BIA-ALCL. But women don’t always have obvious symptoms. “Although BIA-ALCL is treatable if caught early, no one wants to wait to see if they get cancer,” says Sara Castro, an attorney at Farr law firm in Punta Gorda, Fla., who is working with affected women.

Another hurdle: Though Allergan will pay for replacement implants in the case of a cancer diagnosis or implant defect, it doesn’t cover the surgical costs of preventive implant removal. Most insurers won’t cover it, either.

Scot Glasberg, M.D., past president of the American Society of Plastic Surgeons and a consultant for Allergan, says that “if a woman has any concerns whatsoever, she should see a plastic surgeon who is board certified,” specializes in breast implants, and is knowledgeable about BIA-ALCL to go over her screening and testing options.

Women considering breast-implant surgery (or any medical device procedure) should ask their surgeon for an informed consent form that details what the device contains, and known risks. “This form is not mandated yet,” says Hollrah, who did not have that protection before her surgery and has since worked with Zuckerman, Glasberg, and others to develop a patient form and clearer warnings. And they have made progress on that front: On October 24, 2019, the FDA recommended that patient labeling for breast implants include a patient decision checklist, a boxed warning, an information booklet, and a patient device card. A final decision on that recommendation isn’t expected until 2020 at the earliest. 

Madris Tomes, a former program manager at the FDA who now runs Device Events—which gathers adverse event reports on medical devices—recommends researching your device. One free source is an online FDA database called MAUDE (Manufacturer and User Facility Device Experience). “Two-thirds of all recalls begin as an adverse event report,” Tomes says.

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Read the original article here.

FDA calls for new warnings for breast implants

Laurie McGinley, The Washington Post: October 23, 2019.


The Food and Drug Administration, under fire from women who say they were harmed by breast implants, proposed on Wednesday that manufacturers detail possible complications from the devices, including rare cancers, a range of other symptoms and the need for additional surgeries.

The agency recommended that manufacturers use a boxed warning — the FDA’s strictest caution — to clearly spell out the risks of implants, including that they are not lifetime devices and that the chances of complications increase over time. The warning also would list the devices’ association with a rare form of lymphoma and say some patients have reported fatigue, muscle aches and joint pain.

The agency also proposed that patients be given a checklist to guide conversations with their surgeons about the risks and benefits of implants before women put down deposits for their surgeries. The move is a response to complaints from patients who said they weren’t adequately told about potential problems before surgery.

“We have heard from many women that they are not fully informed of the risks when considering breast implants,” FDA Principal Deputy Commissioner Amy Abernethy and Jeff Shuren, director of the agency’s Center for Devices and Radiological Health, said in a statement. The new recommendations are “designed to help inform conversations between patients and health care professionals when breast implants are being considered,” they added.

The FDA’s steps are the latest effort to deal with reports of complications involving devices that have been at the center of sometimes angry debate and legal actions for decades. The devices are used in about 400,000 surgeries in the United States every year, with 75 percent of the women involved getting implants for cosmetic reasons. Most of the rest get them as part of reconstruction after surgery for breast cancer.

Over the past few years, patients who say they were harmed by the devices have become increasingly active on social media sites that have enabled tens of thousands of patients to exchange information. The emergence of a rare cancer linked to implants in recent years also has drawn more attention to potential health problems associated with implants.

The FDA has said that 573 cases worldwide have linked the implants to a rare cancer since the agency began tracking the issue in 2011. The vast majority of those cases involved Allergan textured implants, which have been recalled. Thirty-three women have died of what’s known as breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system, the agency said. At the same time, thousands of women have complained of fatigue, brain fog and other problems that collectively are called “breast implant illness.”

Nicole Daruda, an activist from Vancouver, Canada, who runs one of the most popular websites for women who have had trouble with implants, welcomed the FDA’s announcement, but said it was long overdue. “This is what needs to happen,” said Daruda, who had her implants removed after experiencing several health problems. “But I don’t think it would have without our putting intense pressure” on the agency.

Diana Zuckerman, president of the nonprofit National Center for Health Research who has been working on implant issues for 30 years, said the FDA’s moves are “very important.” But she expressed concern they might yet be weakened, and are not legally binding because they are in the form of “guidance” to the industry. Whether the implant makers actually follow the recommendations “depends on how much pressure the FDA puts on the manufacturers,” she said.

The FDA’s steps are the latest in the agency’s stepped-up scrutiny of the devices, which included a dramatic two-day hearing in March during which many women demanded the FDA take steps to ensure patients have more information about the devices. About the same time, Zuckerman and Scot Glasberg, a past president of the American Society of Plastic Surgeons, formed a working group that included activists to make recommendations to the FDA, including for a boxed warning and a patient checklist of possible problems.

What the FDA is proposing “is very close to what we gave them,” Glasberg said, adding that other groups also made suggestions to the agency.

More than 70,000 women also signed a petition asking the FDA to require a checklist. The FDA, in issuing its recommendations on Wednesday, asked for public comment for 60 days before finalizing the guidance.

Breast implants became available in the United States in the 1960s. Three decades later, after years of reports about ruptured devices and possible links to autoimmune diseases, the FDA called for a moratorium on their use, saying manufacturers had not proved the devices’ safety and effectiveness. The devices were available only for cancer patients who were undergoing reconstructive procedures, and even then, only as part of a clinical trial. In 2006, the agency lifted the ban, approving two new silicone implants.

In 2011, the FDA issued a safety communication saying that women with breast implants might have a small increased risk of developing the rare lymphoma. In July, the implant maker Allergan announced a worldwide recall of its Biocell textured breast implants after the FDA found a sharp increase in a rare cancer and deaths linked to the products and asked the company to withdraw them from the U.S. market.

The FDA, in its proposed guidance Wednesday, also called for new screening guidelines for possible ruptures, as well as a recommendation that manufacturers include product ingredient information in the devices’ labeling that is easy for patients to understand.

Read the original article here.

29-Year-Old Fitness Model Gets Breast Implants Removed after She Says the Silicone Gave Her Seven Years of ‘Brain Fog, Bald Spots and Rashes’

Mary Kekatos, Daily Mail: December 19, 2018.


A fitness blogger said she had her breast implants removed because the silicone was ‘poisoning’ her.

Sia Cooper, the 29-year-old behind the blog Diary of a Fit Mommy, revealed she got implants in October 2011 to boost her self-confidence after weight loss left her with small breasts.

However, over the next seven years, the Florida mother-of-two struggled with extreme fatigue, facial rashes, chest pain, brain fog and even hair loss.

post-explant, 2 weeks

After undergoing multiple blood tests, diagnostic tests and X-rays that came back negative, Cooper was convinced her symptoms were related to what described as  ‘breast implant illness’.

 

Are breast implants safe? What is FDA’s Track Record?

Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

In 2013, a study showed that a rare cancer of the immune system, ALCL, which had previously been linked to saline breast implants and silicone breast implants, was caused by breast implants and could be fatal.  The latest research indicates that this cancer is sometimes cured by removing the breast implants, but at other times also requires radiation and chemotherapy; in some cases, the patients died despite treatment. Although the FDA had reported in 2011 that ALCL might be caused by breast implants, the agency didn’t update its website when the 2013 study was published.  It took the FDA more than 3 more years to revise articles on its website indicating that breast implants caused ALCL ( to conclude that breast implants could cause ALCL. The FDA reported that they have received 359 reports of ALCL among women with breast implants through February 2017. It’s likely there are still numerous unreported cases; for example, Australia’s medical agency estimates that one in 1,000women with breast implants develops ALCL.  There is no reason to think American women would be less likely to develop ALCL, and that would result in several thousand U.S. women developing ALCL

This is just the latest bad news for women with breast implants, and for the government agencies that have allowed them on the market with inadequate studies or warnings.  For example, in 2011, tens of thousands of defective breast implants made by PIP were recalled in Europe. An article in the December 2012 issue of the British medical journal Reproductive Health Matters explains how these developments illustrate the strengths and weaknesses of the safeguards intended to protect patients in different countries from unsafe breast implants and other medical devices.  In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. This standard is higher than the FDA requires for hip joints, numerous cardiac devices, and many other medical implants. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in Europe. As a result of these differing standards, the PIP breast implants that were recalled across Europe had already been removed from the U.S. market years earlier. The FDA was justifiably proud that they had done a better job of protecting breast cancer patients and cosmetic augmentation patients than the EU regulatory system. Nevertheless, the FDA track record on breast implants shows how limited those safeguards can be. The FDA required two breast implant companies to conduct enormous 10-year studies of breast implants, but has done little to ensure that the studies are providing useful information to patients.

The authors conclude that neither the European Union nor the U.S. has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. In addition, the CEO of PIP was sentenced to 4 years in prison by a French Court, and in January 2017, a French court demanded that the German regulatory company that had certified PIP implants as safe pay $60 million euros to women harmed by PIP implants. This is only 3,000 euros each to 20,000 women, however.

Meanwhile, the FDA shows no indication that they will improve their safeguards on breast implants or other medical implants; in fact, those safeguards have weakened since 2012.

For more information about ALCL caused by breast implants, see:

Miranda RN, Aladily TN, Prince HM, et al: Breast implant–associated anaplastic large-cell lymphoma: Long-term follow-up of 60 patients. J Clin Oncol 32:114-120, 2014.

Mazzucco, AE.  Next Steps for Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol, 2014.  Early Release publication. June 16, 2014.