Tag Archives: breast implants

My breast implants are making me sick — and I’m not alone

Pamela Appea, Salon: June 20, 2021


In November 2016, a few weeks after I had breast implant surgery, I came down with an unexpected case of thrush (an unappealing fungal infection characterized by a thick white coating on my tongue). As a Black married mother of two, even though I was still sick, I tried — but failed — to power through and take care of my kids. With intense flu-like aches, pain, and fever, it hurt to eat, drink, swallow, or even open my mouth. I couldn’t properly brush my teeth for several days.

Unfortunately, my primary care physician was on vacation. Panicked, I called the Manhattan oncologist whom I had seen a few weeks earlier. He’d been very kind to me following my DCIS breast cancer diagnosis, unilateral mastectomy and post-surgical treatment. The officer’s medical team could barely understand me when I tried to make the appointment on the phone.

“I don’t think you have thrush — didn’t I just see you a few weeks ago?” he said, trying to put me at ease as I stared at his cheerful neon tie. (I think he prided himself on his fun ties.)

It was torture opening my mouth so the doctor could diagnose me.

“Okay, that’s the worst case of thrush I’ve seen in some time,” the seasoned specialist said. He said he was putting me on antibiotics stat. I asked — or rather, wrote on a notepad, since I couldn’t speak clearly — if there could be any connection between the my immune system and the very new breast implant that was now in my body. The oncologist emphatically dismissed the notion as impossible.

Once he got the results of my lab work back, my physician said there was no evidence of anything wrong; I should bounce back in a few days. “These things sometimes happen,” he told me, smiling as he ushered me out.

While the antibiotics eventually cleared up the thrush, unfortunately I have never fully bounced back. In subsequent years since my breast implants were put in, it became even more clear that something was going on with my immune system. But none of my doctors really listened.

Although it was not formerly recognized by the medical community until recently, Breast Implant Illness (BII) has, in the past few years, finally received attention from both media and researchers. Nicole Daruda founded a Facebook’s support group, called Breast Implant Illness Healing by Nicole, in 2013; now, it boasts over 145,000 members. Daruda tentatively estimates that 50,000 women in the US have BII, although precise research-backed numbers are not readily available

“We are overwhelmed by women trying to join the Facebook group to be educated about Breast Implant Illness,” Daruda said. She estimates that 3,000 to 5,000 women message the group’s moderators every month. To try to meet the demand, Daruda later founded a nonprofit, Healing Breast Implant Illness Society of North America.

Research is just barely starting to emerge on BII. One study, published in Annals of Plastic Surgery in 2020, followed 750 women suffering from Breast Implant Illness over a multi-year time period. Once these women surgically removed their breast implants, the vast majority reported the majority of their symptoms had significantly improved or disappeared entirely.

Awareness appears to be growing, too. A wave of celebrities are talking more openly about breast implants and their health and wellness — including Victoria Beckham, Ayesha Curry, Ashley Tisdale, Chrissy Teigen and others.

A documentary that touches on the subject of BII, “Explant,” is screening right now at the Tribeca Film Festival. The film follows Michelle Visage, one of the celebrity judges on “RuPaul’s Drag Race.” Visage, a media personality, singer, DJ and actor who was well known for her signature Double-D breasts, found that doctors didn’t take her seriously when she told the specialists her immune system was out of whack. Visage experienced chronic health issues, including Hashimoto’s disease, that she now attributes to her breast implants.

Awareness of BII is crucial given the popularity of breast implants. Since 1998, the number of breast augmentation procedures in the US has increased threefold; now, they are one of the most sought-out cosmetic procedures.

The desire for breast augmentation seems so powerful regardless of what else is going on in the world,” said Dr. Diana Zuckerman, founder of the National Center for Health Research. “What most concerns me is how reluctant most plastic surgeons have been to make sure their patients know the risks before making a decision.”

Because breast implant technology has existed for decades, many women erroneously believe they are safe.

[….]

In the years after my implant, some of my symptoms mirrored women on support groups I found online, which is how I figured out I had Breast Implant Illness. While symptoms sometimes waxed and waned, I got used to experiencing a host of autoimmune and other symptoms like insomnia, brain fog, extreme breathlessness, cuts that took weeks to heal, rashes, frequent colds and much more.

But BII is no longer regarded as a myth. Many or even most doctors, including plastic surgeon Dr. Anthony Youn, believe Breast Implant Illness is real. Dr. Youn acknowledges it is a controversial topic among many of his fellow American plastic surgeons.

“If you’re happy with your breast implants and you don’t believe they are adversely affecting your health, then there is no need for treatment. If you are sick and believe your implants may be the cause, speak with your primary care physician and a board-certified plastic surgeon about whether explantation may be a possible solution for you,” Dr Youn said. “There are many causes of the symptoms of Breast Implant Illness (BII) that don’t involve breast implants, so it’s often best to rule those out first,” he continued.

In his 17 years of practice in the metro Detroit region, Dr. Youn, a member of the American Society of Plastic Surgeons and The Aesthetic Society, has performed surgery on thousands of women who elected to get breast implants. Anecdotally, he estimates the number patients who later returned to his practice stating they had Breast Implant Illness symptoms is an extremely small percentage.

[….]

Though not all women with breast implants go on to develop Breast Implant Illness, all women deserve education, informed consent, insurance coverage and most important information about potential risks. If, in 2015, there had been an FDA Breast Implant Black Box Warning (which was officially unveiled in late 2020), I honestly never would have gotten breast implants in the first place.

To read the entire article, click 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

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

 

 

Alternatives to Breast Implants: Lifts and Fat Transfers


When considering cosmetic breast augmentation, women typically consider implants as their main option. However, there are several other procedures to change how your breasts look that may have fewer risks and complications compared to breast implants. These alternatives include breast lifts and fat transfers.

Breast Lifts

Breast lifts, clinically called a “mastopexy,” raise and reshape the breasts. Surgeons remove extra skin and tighten surrounding tissue. In addition to reshaping the breasts, a lift can reposition the nipple and reduce the size of the areola if it has become enlarged over time. Many women choose to get breast lifts to improve the stretching or sagging of their breasts that could have been caused by pregnancy, weight fluctuations, and simple gravity. A breast lift alone cannot make breasts larger, but breasts will look fuller and more perky after the procedure. 1

There are four types of breast lift techniques, which depend on breast and areola size and shape, degree of sagging, amount of skin that must be removed, and the elasticity of skin. For women who have smaller breasts or minor sagging, a crescent or donut technique can be used to create small incisions around the areola. For women who have larger breasts and more severe sagging, surgeons will need to create multiple incisions, either around the areola and vertically down the middle of the breast (a lollipop technique) or including a horizontal incision along the breast crease (an anchor technique). 2

Swelling and bruising will last for about two weeks, and numbness may last up to six weeks. Final results of breast lifts will appear over the months following the procedure as the breasts settle into their new shape and position. Results of a breast lift procedure are long-lasting, especially with a healthy lifestyle. Women with smaller breasts will likely have results that last longer than women with larger breasts. It is also important to note that the cosmetic appearance of the breasts can change due to pregnancy, breast feeding, and significant weight changes that occur after surgery. Therefore, women should consider whether they are planning a pregnancy in the near future before having a breast lift. 3

Risks of Breast Lifts 

When considering a breast lift, it is important to consider the risks of the procedures in addition to the benefits. For breast lift procedures, the most common risks include changes in nipple or breast sensation, asymmetrical breast shape, and partial or total loss of the areola.1 Less common risks that some patients experience are bleeding or hematoma formation, infection, poor incision healing, fat necrosis (fatty tissue around skin may die), and fluid accumulation. Although patients will have scars from a breast lift procedure, many notice that some scarring is hidden in natural contours of the breasts and that scars improve over time, typically within one year.3 As with any cosmetic procedure, some patients may be unhappy with the final result. Your chances of getting the results you want will be better if you choose a board certified plastic surgeon with a lot of experience doing breast lifts without breast implants.

Some plastic surgeons recommend getting both a breast lift and implants to get the best cosmetic result. However, that means patients will face the risks of the lift and the additional risks of the implants. While the breast lift procedure alone is safer than getting implants, there is still a lack of safety data and research on breast lifts to know how often complications occur in the solo procedure. The skill and experience of the plastic surgeon makes a big difference.

Fat Transfer

Fat transfers may be a good option for women who want to have more natural looking, fuller breasts without implants. Fat transfers use liposuction to remove fat from other parts of the body and insert it into the breasts. Fat for liposuction is typically taken from areas such as the back, thighs, abdomen, and buttocks. 4 Next, the fat cells are processed into a liquid so they can be injected into the breast area. 5 The surgeon will slowly inject the fat liquid to multiple areas of the breast until the desired breast size is achieved. Since the procedure uses body fat from the patient, thin women may not be good candidates for this procedure. Because the injected fat does not contain its own blood supply, only a small amount of fat can be injected at a time. Patients should not expect to gain more than one cup size. 

Patients typically notice improvement right after the procedure, but the final results will appear one year after surgery when swelling has gone down. Multiple follow-up fat transfer procedures may be necessary to maintain the shape of the breasts. In many cases, fat that has been injected into the breasts may be reabsorbed by the body over time, move to other parts of the body, or die, causing breasts to lose volume.5 Therefore, surgeons may recommend follow-up sessions to repeat the procedure, which may be expensive and is an important factor to consider.

Risks of Fat Transfers

High patient and surgeon satisfaction as well as low complication rates have been reported for fat transfer procedures, but outcomes vary greatly based on the surgeon as the procedure is not yet standardized. 6, 7 The most common complications from fat transfers include development of cysts (lumps) or fat necrosis, which is when the transferred fat dies and is reabsorbed by the body. 8 Fat necrosis is more common when a large amount of fat is injected. This usually does not need to be treated, as the body takes care of the dead cells on its own. 

Other less common complications can include infection and calcification of the fat.8 Like fat necrosis, these complications are more common when a large amount of fat is injected. Because the injected fat does not have its own blood supply, too much injected fat may lead to microcalcifications, which is when the fat hardens. These calcifications are usually harmless, but they may look like breast cancer on a mammogram, resulting in stressful and expensive breast biopsies.

Bottom Line

Despite risks, lifts and fat transfers appear to be safer than breast implants. Breast implants are not lifetime devices, and women should expect additional surgery to replace them every 10-15 years if not more often. Health insurance often does not pay for removal or complications for augmentation patients and never pays for replacement of cosmetic implants. The high cost of these additional surgeries, as well as the common complications from implants, make lifts and transfers a safer option for many patients.

While breast lifts and fat transfers provide alternatives to breast implants for cosmetic breast enhancement, patients must consider the risks of both procedures before choosing to undergo surgery. More long-term research is needed to confirm the safety and effectiveness of both procedures.

When deciding whether or not to undergo cosmetic breast augmentation, it is important to weigh the risks and benefits of each procedure with a highly skilled, experienced surgeon who is board certified in plastic surgery, so you can make a decision that is right for you. 

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

Ben Oldach, WHO TV: May 21, 2018.

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

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

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

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

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

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

Read the original article here.

25 Reasons Not to Get Breast Implants

Dr. Nalini Chilkov, The Huffington Post: Dec 7, 2017

Last week the FDA reported that breast implants put women’s lives in danger. The big news last week was that a small number of women can get a very rare type of cancer (ALCL: anaplastic large cell lymphoma). It confirmed that death is a possible side effect of breast implants. […]

According to Diana Zuckerman, Ph.D., Elizabeth Nagelin-Anderson, M.A.
and Elizabeth Santoro, R.N., M.P.H.: In 2008, more than 300,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants, and almost 80,000 breast cancer patients had reconstruction after mastectomy, often with implants. The popularity of breast augmentation has more than tripled since 1997, when there were just over 101,000 of these procedures. More than 40,000 implant removal procedures were also reported in 2008. […]

In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture increases every year. Silicone-7 migrated outside of the breast capsule for 21 percent of the women, even though most women were unaware that this had happened.

Don’t forget the financial burden and increased health insurance costs that go with multiple surgeries and medical complications. In some cases the surgery to remove implants can be like a mastectomy, complete removal of the breast tissue and sometimes the muscle underneath.

Read the original article here.

 

A Shocking Diagnosis: Breast Implants “Gave Me Cancer”

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

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

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

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

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

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

Diagnosis and Treatment

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

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

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

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

Read the original article here.

Can Breast Implants Cause Cancer? WJLA Investigates


“You have cancer — again.”

“What? Breast cancer?”

“No … a new one.”

So went the conversation between a stunned 40-year-old Raylene Hollrah and the plastic surgeon who performed her reconstructive surgery after she survived breast cancer seven years earlier.

Her new cancer diagnosis? Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL for short. Of all the potential side effects of breast implants, she did not recall her surgeon ever mentioning a small but increased risk of cancer.

“I did everything to keep cancer away,” Hollrah told 7 On Your Side. “Yet, I put a device in my body that caused cancer.”

The US Food and Drug Administration is not prepared to say that the textured breast implants Hollrah chose cause lymphoma, a cancer of the immune system.

But in 2011 and again in 2016, the FDA cautioned of a “possible association” between ALCL and implants. […]

When 7 On Your Side filed a Freedom of Information Request (FOIA) about ALCL cases reported to the FDA, we received more than 800 documents representing 441 cases, more than one-third unconfirmed, and at least 12 deaths. Even since the 2011 advisory from the FDA about ALCL and implants, when manufacturers responded to reported adverse events, they often listed many risks but didn’t include ALCL. […]

7 On Your Side spoke with a leader in the field of women’s health, Diana Zuckerman, PhD, President of the National Center for Health Research. Zuckerman was our chief source for information about the risk of suicide after implants. Regarding BIA-ALCL, she wrote:

“It is not true that textured implants are the only ones associated with BIA-ALCL. This summary of a recent medical journal article clearly says that “most women with ALCL have at least one textured implant” but that doesn’t mean they all do.

Read the original article here.

Can Having Breast Implants Lead to Suicide? 7 On Your Side Investigates

Kimberly Suiters, WJLA ABC7: November 7, 2016.

Three-hundred thousand women will get breast implants this year, making it the number one cosmetic surgery in the U.S. Research shows the typical breast implant patient has high self-esteem and good mental health, higher and better than the general population. According to implant manufacturers, satisfaction rates top the 83-97 percentile range, excellent results for any kind of surgery. So why would some women with breast implants have a higher rate of suicide than women who don’t have them?

“Maybe just a coincidence,” Dr. Scott Spear, a well-known plastic surgeon in Washington, D.C., told 7 On Your Side. “There may be an association between breast implants and suicide, but it’s probably a loose association.”

That’s not the way Diana Zuckerman, PhD, president of the National Research Center for Women and Families, sees it. Not at all.

“When you look at suicide and implants, the women with breast implants are more likely to kill themselves.”

How much more likely? Anywhere from two to 12 times. Zuckerman wrote about that conclusion after evaluating seven studies on the topic.

“Some surgeons believe if a woman with implants kills herself, she must’ve had something wrong to begin with; that she got implants because of low self-esteem, depression, to feel better. But women with implants are more likely to kill themselves than with other (plastic) surgeries. Why would a mastectomy patient be 10 times as likely to kill herself as a mastectomy patient who doesn’t have implants?”

Zuckerman doesn’t know that answer definitively, but she is convinced there is something physiological or mental that causes women with implants to have a diminished view of themselves.

The number of women who get to that tragic point is small. According to the CDC: 9.8 women per 100,000 will commit suicide. And middle-aged women, in general, had the largest increase in suicide in the last 15 years, up 63 percent.

Dr. Zuckerman said women going through menopause are one of the highest risk groups. Their bodies have changed after giving birth, and they may be lured in by “Mommy Makeover” marketing.

“But according to research,” she said, “it’s a bad time. A dangerous time.”

[…]

Read the original article here.

F.D.A. Affirms Safety of Breast Implants

Gardener Harris, The New York Times: August 31, 2011.

WASHINGTON — After two days of discussion and testimony about silicone breast implants, a top government health official said he had heard nothing to shake his faith in the safety of the widely used implants.

The official, Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices, said silicone breast implants were safe. […]

Some patients and women’s groups who testified at the meeting disagreed.

Diana Zuckerman, president of the National Center for Health Research, a research and education group, told an expert panel that the two companies that manufacture silicone breast implants — Johnson & Johnson and Allergan — had done a poor job of studying patients who got the implants, as the F.D.A. required them to do.

“And without proper data, we still don’t know how safe or effective they are and whether there are certain patients at risk for extremely negative outcomes,” Ms. Zuckerman said. […]

There was some criticism of the 27-page research form that patients who participate in the study are required to complete and whether it could be shortened. Nearly all expressed hope that a registry could be created that would follow all breast implant patients, but such registries are expensive to maintain and complicated to create. […]

Read the original article here.