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The Costs of Getting Breast Implants

Augmentation Costs

If you are thinking about getting breast implants, you should be fully aware of the initial and ongoing costs of breast implants. According to 2020 data from the American Society of Plastic Surgeons, the average breast augmentation surgery costs $4,516.1

That average cost only includes the plastic surgeon’s fee. It does not include fees for anesthesia, the operating room, or other surgical expenses like bandages or stitches. After all the fees, the surgery usually costs between $5,000 to $8,000. This price includes a follow-up visit after the surgery. Silicone gel breast implants usually cost about $1,000 more than saline implants. If you are considering augmentation, you can request an itemized bill before your surgery to see what all of the costs will be.

If you’re wondering whether you can afford breast implants, there are other costs to be aware of. For example, you may need additional funds for any complications from the implant, such as infection, rupture, pain, or asymmetry. Complication rates for breast augmentation surgeries are higher than you might think. The FDA found that between 20-40% of augmentation patients required at least one revision surgery within 10 years.2

The FDA says that all women getting breast implants should assume that they will require additional surgeries.3

Because these additional surgeries can cost as much — if not more — as the initial surgery, we suggest that women considering breast implants make sure they have at least $5,000-8,000 saved in case any problems arise.

It is important to know that most insurance companies will not cover the costs of breast augmentation surgery. In addition, if you have problems with your breast implants, your insurance plan might not cover things like an MRI, consultations with your doctor, antibiotics, etc. If it is medically necessary to get your implants removed, many insurance companies do not cover the costs of removal if your implants were placed for cosmetic reasons. You can read more about the costs of breast implant revision and removal surgeries here.

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

How Do You Know if You Need to Remove Your Implants?

Augmentation Remove, Reconstruction Removal

 

Breast implants do not last a lifetime. If you get breast implants, you should expect that you will need additional surgery in the future to fix problems or remove your implants. How do you know if that time has come? You can read more about the potential complications of breast implants here. Below are some helpful insights that can help you decide if it’s time to consider removing your implants.

Are your implants ruptured or leaking? 

If you have silicone gel filled implants, the FDA recommends that you get a breast coil MRI regularly to detect ruptures that have no symptoms.  When silicone breast implants were first approved, the FDA recommended that all women undergo a breast MRI 3 years after getting breast implants, and every other year after that. However, because of the expense and the reluctance of plastic surgeons to encourage MRIs for silent ruptures, very few women followed the FDA’s advice.  As of October 2020, FDA now recommends an MRI 5-6 years after the initial surgery and every 2-3 years after that. If a leak or rupture is confirmed you will need to have the implant removed as soon as possible.  Ruptured silicone gel implants should be removed en bloc and by an experienced plastic surgeon. Remember that not all ruptures of silicone gel implants will show up on breast coil MRIs or ultrasounds. If your implants are more than 10 years old or you suspect they may be ruptured, you should consider removal as you may have a silent, undetected leak. 

Are you having trouble concentrating, fatigue or other unexplained illnesses?

It could be a sign that you are experiencing autoimmune symptoms that may be a result of your breast implants. If other possible causes have been eliminated by testing, your symptoms have not resolved on their own, and/or you haven’t been able to successfully manage your symptoms with other medical treatments, you may want to consider removing your implants. If you suspect that your autoimmune symptoms or “breast implant illness” are directly linked to your breast implants, you may want to discuss getting your implants removed with a plastic surgeon who is very experienced at removing problem implants. There is now clear scientific evidence establishing a connection between breast implants and autoimmune symptoms, and research shows that most women report significant improvements in their symptoms after removal.  You can read about another woman’s experience with breast implant illness here, and you can read about the recent research here.

Are you concerned about the possibility of BIA-ALCL? Have you developed a lump or swelling around your implant?

If you have been diagnosed with breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) you should get your implants removed as soon as possible. If you have textured breast implants, you are at risk for BIA-ALCL.  However, that does not mean you should immediately get your breast implants removed, if you are not having any other symptoms from your breast implants. BIA-ALCL is rare and treatable if caught early. If you are not experiencing any other symptoms from your implants, the risks of explant surgery may outweigh the benefits. You should monitor your breasts for changes and symptoms of ALCL and see a doctor regularly. If you have textured implants and are having other symptoms like rupture, capsular contracture, breast pain, autoimmune symptoms, or overwhelming anxiety from having textured implants, it may be time to consider permanent removal of your implants.

Key Takeaways

Ultimately, if you suspect that you are experiencing any symptoms from your breast implants it is in your best interest to discuss with a health professional if removal is the best choice for you. Other issues that may lead you to consider breast implant removal include, added weight and strain on the neck, back and shoulders, infections that are not treatable by antibiotics, and unhappiness with how your breasts look. When making your decision, remember that if you decide to replace your implants the risk of complications coming back is high. If you are considering permanent removal, it is important to keep in mind that that your breasts may not look the same as they did before your breast implant surgery. There is likely to be loose skin and changes in the rib area. If this concerns you, you can see an experienced plastic surgeon and discuss alternatives to breast implants to improve the cosmetic look of the breasts, such as a breast lift. You can learn more about breast lifts here.

Removing breast implants is a more complicated surgery than putting them in and requires a skilled plastic surgeon. For more information on finding an experienced plastic surgeon to remove your breast implants, click here.

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

The Costs of Revising or Removing Breast Implants

Augmentation Costs

Breast implants are not lifetime devices and complications are common. Based on studies conducted by implant companies, the FDA concluded that as many as 20% of augmentation patients will have to have their implants removed within 8-10 years.4 Since many women dropped out of the original safety and efficacy studies (read more here), the proportion of women needing additional surgery is likely much higher. Revision or removal surgeries often cost as much as the initial surgery, if not more. Revision surgeries might involve replacing implants or correcting the visual appearance of breast implants. If problems with your breast implants are bad enough or can’t be fixed, it may be necessary to permanently remove the implants.

In 2020, the average surgeon’s fee for removal of breast implants was $3,049, according to the American Society of Plastic Surgeons but that does not include the additional costs of surgery such as anesthesia.5 Our review of various plastic surgery websites revealed that the total average cost for breast implant removal is between $5,000-$8,000. The cost of removal varies by surgeon, geographic region, and the complexity of the procedure. If you choose to replace your implants, you can expect to pay an additional $2,500-$3,500.

Some women choose to instead have a breast lift, either following a permanent removal of implants or in addition to replacement implants. A breast lift typically costs another $5,000. A breast lift without replacement implants is a good option for women who want to avoid future surgeries or complications from implants. A breast lift is a one-time expense, but the replacement implants are likely to need to be replaced in later years.

There are many reasons women will need to have additional surgery to remove or revise their breast implants. Implant companies admit that breast implants will not last a lifetime, even if your surgeon told you that they would. Rupture, capsular contracture, and cosmetic corrections are some of the most common reasons women need to have additional surgeries. Depending on the complexity of the procedure, the costs of removing your breast implants may be much higher. Removal of breast implants can be very expensive, especially if they are leaking silicone gel.

If you are looking to have your breast implants removed, it is recommended that you look for a surgeon who is experienced in en bloc removal, especially if you have leaking silicone gel filled breast implants. An en bloc removal is when the surgeon removes the scar tissue (or capsule) and implant at the same time, with the implant still inside the intact scar tissue capsule. En bloc removal prevents silicone, other chemicals, and bacteria from leaking into the woman’s body during surgery. En bloc removal prices vary by surgeon, geographic region, and the complexity of the procedure, but average around $8,000. If you decide you want to have your implants removed, you can learn more about finding a plastic surgeon here.

Some insurance companies do not cover the costs of removal if your implants were placed for cosmetic reasons. Insurance plans that do cover removal require that patients prove that explant surgery is “medically necessary.” Symptoms that are considered medically necessary reasons for breast implant removal vary by plan but typically include rupture, capsular contracture (Baker level III or IV), infection, and chronic pain. You will also need a doctor to advocate for you and communicate to your insurance company that removal is medically necessary. You can read more about trying to get insurance coverage for your breast implant removal here or contact us at info@breastimplantinfo.org.

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

Costs of Breast Reconstruction After Mastectomy

Reconstruction Costs

If you are considering a mastectomy or lumpectomy and thinking about reconstructive surgery, you may want to know about the initial and ongoing costs.

The Women’s Health and Cancer Rights Act of 1998 is a law that requires that private insurance companies pay for breast reconstruction if they pay for mastectomies.  This includes reconstruction on the removed breast, modification of the other breast to create a symmetric appearance, and treatment of any complications that result from a mastectomy or reconstruction.  The forms of reconstruction covered may vary by state and insurance provider, so it is important that you call your insurance provider to see which options will be covered in your particular case. You will also still be responsible for deductibles and co-payments, which can be substantial.

There are two major types of reconstructive surgery: breast implant reconstruction and autologous tissue transfer reconstruction (also called Flap Procedures). Experts recommend tissue transfer surgery when it is possible. You can learn more about the types of reconstruction options here.

The cost of breast reconstructive surgery varies greatly, and most patients with health insurance only pay a fraction of the total cost. Surgeons who live in certain geographic areas and those with more experience, often charge more for the surgery. If you choose reconstruction of both breasts, the surgery will be more expensive than for one breast.

You can request an itemized bill before your reconstructive surgery to see the total costs and what you will be responsible for paying.

Costs for Implant Based Reconstruction

The surgery will also cost more if you get an implant in the other breast to make your breasts symmetrical, rather than just one implant. In addition, silicone gel-filled breast implants usually cost about $1,000 more than saline-filled implants.  In addition to the thousands of dollars for the surgeon’s fee and for the implants, there will also many other costs related to the surgery, like fees for hospitalization, anesthesia, and imaging.

If you are considering implant reconstruction, you should be aware that the costs continue in the years after your reconstructive surgery. For example, you will need additional treatment and/or surgery if you experience complications from the implants, like infection, rupture, pain, or asymmetry. Women who undergo reconstructive surgery have higher complication rates than women who undergo cosmetic breast augmentation. Some complications can only be fixed through another surgery, which is called a revision surgery. For example, a study conducted by a major implant manufacturer found that 46% of reconstruction patients needed additional surgery within the first 2-3 years after getting silicone gel-filled breast implants. The Women’s Health and Cancer Rights Act requires that private insurance companies pay for any treatment of any complications that result from a mastectomy or reconstruction. However, even if these these revision surgeries are covered by insurance, you are still responsible for deductibles and co-pays.

Because most women don’t notice when a silicone gel implant ruptures, the FDA recommends having breast MRIs regularly to detect ruptures that have no symptoms.  When silicone breast implants were first approved, the FDA recommended that all women undergo a breast MRI 3 years after getting breast implants, and every other year after that. However, because of the expense and the reluctance of plastic surgeons to encourage MRIs for silent ruptures, very few women followed the FDA’s advice.  As of October 2020, FDA now recommends an MRI 5-6 years after the initial surgery and every 2-3 years after that. Unfortunately, a breast MRI costs about $2,000 or more.  Most insurance policies will not cover an MRI to check for implant leakage unless there are symptoms of a rupture, such as burning or changes in size or shape.

Even though it’s expensive, an MRI is the most accurate test to show if your silicone gel implants have ruptured, so that you can have them removed before they leak into your breasts and lymph nodes. If you are considering silicone gel breast implants, check to see if your insurance plan covers breast MRIs to regularly check for problems with your implants.

Types of Breast Implants

Augmentation Types

Breast implants can either be filled with saline (salt water) or silicone gel (a synthetic material). All breast implants have an outer shell made of silicone. This shell can be “smooth” or “textured.”

Smooth Implants

Smooth implants feel softer and move more easily in the breast. They can be more prone to wrinkling or rippling than textured implants.

Textured Implants

Textured breast implants are less likely to move or become displaced.

Plastic surgeons prefer textured breast implants for reconstruction patients and some augmentation patients, because they believe they are less likely to move or become displaced.

Breast implants can cause Anaplastic Large Cell Lymphoma (ALCL), a rare cancer of the immune system. Most of the patients who developed this cancer had textured breast implants.  Nobody is certain about why, but it may be that textured implants make it easier for bacteria to grow. You can read more about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) here.

In July 2019, the US Food and Drug Administration (FDA) requested that Allergan recall their Biocell textured breast implants and tissue expanders. The FDA made this request after concluding that the Biocell textured implants are six times as likely as other textured breast implants to cause BIA-ALCL.

This was just 7 months after these breast implants were taken off the European market.   In Europe, breast implants are allowed to be sold if one country provides what is called a CE mark. The CE mark does not require clinical trials and is based on a private company’s review of the product to ensure health, safety, and environmental protection standards are met. The CE mark for Allergan’s textured breast implants was suspended after the company failed to provide French health officials with requested data regarding the textured implants and their link to lymphoma. 1

Following the FDA request for a recall in July 2019, Allergan announced a worldwide recall of their Biocell textured breast implants and tissue expanders. See a full list of recalled models here. The FDA also published an updated safety notice, informing patients to communicate with their health-care professionals if they have any concerns or symptoms of BIA-ALCL.

The controversy about whether other types of textured breast implants should remain on the market has focused on what percentage of women with these implants will develop ALCL.  That is not known, because some women who developed ALCL did not know what brand of breast implants they had.  Other types of textured implants are still being sold in the United States, although the FDA recommends women with textured implants have routine check-ups with their doctors.

In December 2018, Allergan’s textured breast implants were taken off the European market. In Europe, breast implants are allowed to be sold if one country provides what is called a CE mark. The CE mark does not require clinical trials and is based on a private company’s review of the product to ensure health, safety, and environmental protection standards are met. The CE mark for Allergan’s textured breast implants was suspended after the company failed to provide French health officials with requested data regarding the textured implants and their link to lymphoma. 6 This means that, for now, Allergan textured implants cannot be manufactured or sold in Europe and that the textured implants at clinics are being recalled. Textured breast implants are known to increase the chances of developing a rare form of cancer of the immune system known as Breast Implant Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL. The controversy about whether textured breast implants should remain on the market has focused on what percentage of women with these implants will develop ALCL. Despite the well-established increased risk of lymphoma, textured implants are still being sold in the United States, although the FDA recommends women with textured implants have routine check-ups with their doctors.

Saline Implants

Saline implants are made of a silicone envelope that’s filled with saline.

Here are reasons why some women prefer saline implants:

  • Saline implants usually deflate when they leak and the salt water is not usually dangerous.
  • There is no leaking silicone gel that can travel to the breast and other organs, such as the lungs and liver, and cause serious medical problems.
  • There is no need to undergo expensive, periodic MRIs to check for leakage.
  • They are cheaper than silicone implants.
  • There is usually a smaller scar with saline implants than with silicone gel implants because saline implants can be implanted when empty and filled after they are placed in the body.

Here are some common issues with saline implants:

  • Saline and silicone gel implants interfere with mammography.
  • Saline that leaks out of the implant could contain mold or bacteria, which can cause infections.  
  • Textured breast implants (saline- and silicone gel-filled) are linked to Anaplastic Large Cell Lymphoma (ALCL), a type of cancer of the immune system.
  • The silicone envelope surrounding the implant can break over time.
  • They may not look or feel like a natural breast:
    • They don’t feel as warm as the rest of the body in colder weather.
    • The saline solution can slosh within the implant, making audible noises.  
    • They can look round and stiff.
    • They can be heavier than silicone-filled implants and become displaced more easily.
Silicone Implants

Silicone implants are made of a silicone envelope that’s filled with silicone gel. Gummy bear implants are a type of silicone gel-filled implant. The gel in gummy bear implants is thicker than in traditional silicone implants, so they feel firmer. They are not safer than other silicone implants.

Here are reasons why some women prefer silicone implants:

  • They look and feel more natural than saline implants.
  • They weigh less than saline implants.

Here are some common issues with silicone implants:

  • Saline and silicone implants interfere with mammography.
  • Leaks aren’t obvious, so silicone gel can travel to other parts of your body for years before the leak is detected. Silicone gel can be impossible to remove once it travels to breast tissue or other organs, such as the lungs or liver.
  • Leaking silicone can cause pain, swelling, or numbness. It could cause allergic and/or autoimmune reactions.
  • Women with silicone gel implants need regular breast MRIs to check for silicone gel leaks. These are expensive (around $2000) and often aren’t covered by insurance. As of October 2020, FDA now recommends an MRI 5-6 years after the initial surgery and every 2-3 years after that.
  • Textured breast implants (silicone gel- and saline-filled) are linked to Anaplastic Large Cell Lymphoma (ALCL), a type of cancer of the immune system.
  • Silicone gel implants are pre-filled when inserted, so they require a larger incision and leave a bigger scar than saline implants.

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

Finding a Plastic Surgeon to Remove Your Implants

Augmentation Remove, Reconstruction Removal

Finding a plastic surgeon to perform your explant surgery is tricky because it can be a more complicated procedure than placing implants. If you have already had a negative experience with your breast implants, it is very important to find a surgeon that can remove your implants carefully. Your surgeon needs to be able to minimize any silicone leakage or other problems during the surgery.

You should start by looking for a surgeon who understands that breast implants can cause serious health problems, because those surgeons will be more careful when removing your implants. It is also important that your plastic surgeon be board-certified by the American Board of Plastic Surgery. Any doctor can call themselves a plastic surgeon, but only those who are board-certified have extensive training. The ABPS website lists all board-certified surgeons.

En Bloc Removal

Your explant surgeon should be experienced in en bloc removal, whenever possible. En bloc removal is when the surgeon removes the scar tissue (or capsule) and implant at the same time, with the implant still inside the intact scar tissue capsule. This is especially important if your implants are filled with silicone gel, are ruptured, or are very old. En bloc removal allows the silicone and other chemicals to stay inside the intact scar tissue capsule as it is removed. En bloc removal prevents silicone, other chemicals, and bacteria from leaking into the woman’s body during surgery. It requires a larger incision (which can mean a larger scar), but it is worth it because it prevents leakage that can cause health problems.  

Keep in mind that en bloc removal may not be possible in all cases, and your surgeon may not know if an en bloc procedure is possible until you are in surgery. For example, if your scar tissue capsule is very thin or tightly attached to the chest wall, en bloc removal may not be possible.

Total Capsulectomy

En bloc removal is also sometimes referred to as a total capsulectomy, but they are not exactly the same. A total capsulectomy is not always performed using the specific en bloc technique. A total capsulectomy is the removal of the breast implants and all the scar tissue, or capsule, that forms around a breast implant. However, during a total capsulectomy, the implant is not necessarily removed while still inside the intact scar capsule (en bloc method). Most surgeons use the term total capsulectomy to mean that they will cut the scar tissue capsule, remove the implants first, and then go back and remove all of the scar tissue capsule.

What if en bloc removal is not possible?

Let your plastic surgeon know in advance that if en bloc removal is not possible, you want the surgeon to remove as much of the scar tissue capsule as possible. Surgeons who are experienced in en bloc removal will know how to remove your implants and scar capsule material as carefully as possible.

Unfortunately, there are not many surgeons experienced in en bloc removal and most do not take insurance. If you cannot find a surgeon near you that performs en bloc removal, or you are required to see a surgeon inside your insurance network, you should select a surgeon who can perform a total capsulectomy.

If you are paying for the surgery yourself, keep in mind that the most important factor to consider is the expertise of the surgeon in performing en bloc removal. In some cases, women have traveled to experienced surgeons in the U.S. and still spent less than their local, less experienced plastic surgeon.

Your Decision

Once you have selected a board-certified plastic surgeon experienced in explantation, there are several questions you should ask to ensure your surgeon understands your wishes. You should ask the surgeon how many en bloc or total capsulectomy procedures he or she has performed to gauge skill and experience. You can also ask to speak with one of your surgeon’s patients who has had en bloc explantation to hear about their experiences. Finally, you may ask for before and after pictures of the plastic surgeon’s own patients. Here is a one-page resource that lists all the questions you should ask your surgeon at your next consultation. Click here to print this one-page list of questions to take with you to your next consultation.

It is also important that you and your surgeon are on the same page about your priorities for the surgery. In order to help make sure that your surgeon knows how strongly you feel about the surgery, we have created a short acknowledgement form that you can print and take with you to your consultation. This form will be signed by you and your doctor and acknowledges that your doctor understands your desire for an en bloc explant whenever possible. Click here to print the acknowledgement form to take with you to your next consultation.

Insurance Coverage

If you want health insurance coverage for your surgery, you can find out if there are plastic surgeons who participate in your health insurance plan, are board-certified, and experienced in the en bloc or total capsulectomy removal. You can start by contacting your insurance company’s member service line to speak with an insurance representative. Many insurance company websites provide online databases of participating physicians.

As mentioned previously, many plastic surgeons experienced in en bloc or total capsulectomies do not accept or work with insurance. If your plan is likely to cover your breast implant removal, you will need to determine if your plan allows you to see out-of-network surgeons and seek reimbursement. If your plan requires you to see in-network surgeons, you will need to decide how important it is for you to have your surgery done en bloc and how you will raise the funds to pay for the procedure up-front.

Once you find participating surgeons, you can call their offices to ask about their experience with en bloc removal or total capsulectomy.  If the surgeon meets the above criteria, you should request an in-person consultation before scheduling your surgery.

How to Report Problems With Medical Products to the FDA

Augmentation Risks, Reconstruction Risks

Breast implants do not last a lifetime and many women report complications that they did not expect. Many women with breast implants experience implant rupture, capsular contracture, breast or body pain, joint pain and other autoimmune symptoms, mental confusion, rashes, and even cancer of the immune system (ALCL). If you have experienced any of these complications, you could help other women by reporting it to the FDA.

The FDA is responsible for protecting patients and consumers by warning them about the risks of medical products, and taking products off the market if the risks outweigh the benefits.  The main way they gather information about the risks of breast implants (and other types of implants) is when doctors, nurses, and patients report problems through the FDA’s Voluntary MedWatch Report. If the FDA sees that complications are more serious or more frequent than expected, we will urge them to require manufacturers to conduct better research or to pull the product from the market.

You can report any problems caused by your breast implants using this short online form.

You don’t need to remember exactly when the symptoms or complications started, but give an estimate of how long it was after you got your implants.  If you don’t know the exact brand or model of your implant, you should report your problems anyway, but include the brand if you can.  From 2000 to 2015, most breast implants in the US were made  by either Mentor or Allergan (also called Inamed or McGhan).

If you prefer to report your problem over the telephone, you can do that by calling the at 1-800-FDA-1088.

If you are in Canada, you can report medical device complications to Health Canada using this short online form.

If you have problems completing the form, ask for help at info@center4research.org

 

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

Testimony of Linda MacDonald Glenn at the FDA on Silicone Gel Breast Implants

Other Testimonies About Breast Implant Complications
Linda MacDonald Glenn, Women’s Bioethics Project, April 2005

My name is Linda MacDonald Glenn. And I am testifying today on behalf of the Women’s Bioethics Project, a nonprofit, nonpartisan public policy institute dedicated to ensuring that women’s voices, health, and life experiences are brought to bear on ethical issues in healthcare and technology.

I am a biomedical ethicist, attorney, educator, and long-time patient advocate. I spent 20 years as an attorney, a prosecutor, government adviser, and general practitioner. During that time, I was called to the field of biomedical ethics, both personally and professionally. I went back to school to switch my career to biomedical ethics.

Upon graduating in 2002, I went to the American Medical Association, where I was a senior fellow at the Institute of Ethics. I hold a faculty appointment at the University of Vermont. And I was recently given the honor of being named a Woman’s Bioethics Project scholar. I have no financial conflict of interest.

“Tell me what you don’t like about yourself.” This catchphrase is the opening line to the controversial TV drama “Nip/Tuck” that sums up a plastic surgeon’s attitude towards his patient. The implication is that plastic surgeon can fix what you don’t like about yourself.

And while we’re not here today to talk about plastic surgery, we are here to talk about the new silicone breast implants, which manufacturers have promoted as a woman’s choice; in other words, “Let us help you feel better about yourself.” But, as I will follow up and explain, the FDA’s summary of the manufacturer’s own reports indicate that this is a hollow promise.

There are some key ethical issues involved in your decision today. Issues of long-term safety and truly informed consent are the primary concerns.

In biomedical ethics, there are four principles that are weighed and balanced against each other to arrive at an ethically sound decision. Those are the principles of autonomy, the right of control over your own body; benefit, the good that is accomplished from the treatment and the application of technology; no harm, the risks and burdens of the treatment; and justice, a question of fair and equitable access.

The public relations firm hired by the breast implant companies came up with a slogan, “Women have the right to choose breast implants, which chooses to emphasize autonomy. However, if autonomy were the only principle to be considered, there would be no need for the FDA. And there would be no protection against the claims of charlatans and those peddling magic elixirs.

The slogan “The right to choose” implies a benefit that a woman will feel better about herself and her appearance, but, in fact, the data submitted by Mentor Corporation does not bear out that benefit.

Mentor’s own data and the data that Inamed provided in 2003 both showed that on most measures, women feel the same about themselves and their lives two years after getting breast implants compared to before getting breast implants. That is consistent with other research as well, as shown in the FDA summary of Mentor’s reports on pages 66 to 73, indicating there is no measurable benefit for women who have received breast implants.

To quote, in summary, the literature does not provide strong scientific support that breast implants have a measurable psychological and psychosocial benefit for women seeking breast augmentation. Each study had serious flaws, including the apparent exclusion of participants with adverse outcomes. This was true for augmentation and reconstructive patients.

The summary on page 73 explains that Mentor did not provide adequate literature that evaluates the short-term or long-term psychological or psychosocial benefits of breast implants as a reconstructive procedure.

The burdens and potential risks are substantial, not only the risks of invasive major surgery but also serious questions about long-term safety issues regarding silicone leakage, silicone migration, and resulting autoimmune disorders.

Research of women with implants for at least six years found that one in five women had silicone leaking outside the scar capsule and didn’t even know it. Clearly, more studies on long-term safety need to be done.

In terms of ethically sound decision-making, this is what I would call a slam dunk for the Committee. Autonomy, the right to choose, is not a factor when the benefits are not measurable and the burdens and risks are significant. The path this Committee ought to take is clear. These implants should not be approved until clear benefits and long-term safety are established.

Thank you for your thoughtful consideration in listening today.

Testimony of Marcy Gross at the FDA on the Lack of Breast Implant Studies

Other Testimonies About Breast Implant Complications
Marcy Gross, State of Maryland Women’s Health Promotion Council, April 2005.

I am Marcy Gross, a consultant who specializes in women’s health issues. I am a member of the State of Maryland Women’s Health Promotion Council and serve on the boards of various private health organizations.

Prior to becoming a consultant, I worked for the Department of Health, U.S. Department of Health and Human Services, where I was a Senior Policy Analyst for a number of years in the Office of the Assistant Secretary for Health. And in my last position, I was the Senior Adviser for Women’s Health at the Agency for Healthcare Research and Quality, where I served while there on the secretarial ad hoc task force on silicone breast implants.

I give you this resume to establish my familiarity with the issues at hand. However, I am speaking as a private citizen. I have no financial links to any of the applicants.

A legacy from my six-year tenure at AHRQ is an appreciation of the need for a strong evidence base to support medical decisions. One of my concerns today is that an adequate evidence base for the approval of silicone gel breast prosthesis still does not exist. Worse, a truly long-term gold standard study that will produce independent, objective research findings seems not to be on the horizon.

We do have 40 years of experience with breast implants, including 25 years when the silicone implants were available to women, all women. They were pulled from the market for good reason. They were associated with major medical problems.

The basic facts on this issue have not changed in the 14 years subsequent. First, available studies on the health aspects of silicone gel implants are still short-term and are often produced by companies that manufacture the devices or materials.

Second, the work that is available, some from FDA itself, indicates that the rate of complications of implantation, reinfections, reoperations, and other adverse events are sufficiently high to remain a major concern, despite advances in materials.

Third — and this is a change from the past — the Mentor applicant agrees that the devices will not last indefinitely and warned women that they should expect to have them replaced. So the issue becomes one of sequencing in looking at the data. Do we get the data first and approval after or the reverse?

Letting women be living testers I find highly objectionable since these are elective procedures and there are alternatives, especially since the data on improvements in the quality of life for patients undergoing implantation are weak by accepted research standards and most especially since it is expected the devices will fail and will have to be removed.

On this last point, the overall failure rate, it should be noted that Mentor acknowledges that their devices will have a finite in vivo life, which means, really, that all will fail and need to be surgically removed. We just don’t know when.

I would assert that if this were an NIH-funded research study, it’s unlikely it would go forward.

Marcy Lynn Gross passed away unexpectedly on June 19, 2005. Marcy was an important national advocate for women’s health, and formerly a senior adviser with the U.S. Department of Health and Human Services. She worked closely with the National Research Center for Women & Families to prevent medically-unnecessary mastectomies. The Center is naming an internship in her honor.

FDA Update on Silicone Gel Breast Implant Safety: Many Unanswered Questions

How Safe Are They?

 

The FDA released a report entitled Update on the Safety of Silicone Gel-Filled Breast Implants on June 22, 2011. The FDA summarized the report as showing that breast implants cause many complications and often need to be removed, but that if “used as directed” (including regular MRIs) implants are “reasonably safe.” However, the FDA admits that we don’t have as much safety information as we need, and that the implant companies haven’t done a very good job of doing safety studies.

After reviewing the research, we conclude that most of the studies that were conducted by Mentor (Johnson & Johnson) and Allergan are completely inadequate to provide safety information to patients. These studies of 40,000 women for each manufacturer’s study were required as a condition of the approval of silicone gel breast implants in 2006. The goal was for the FDA, patients, and doctors to find out more about the risks of silicone gel breast implants over time. They were intentionally large so that the risks of relatively rare complications, such as autoimmune diseases, could be evaluated. Several years into the studies, most of the patients have dropped out. Only about half of the Allergan augmentation patients stayed in their studies, and most of the Mentor augmentation and reconstruction patients dropped out of the studies. As a result, the studies cannot provide meaningful information about safety for those patients.

Why Can’t the Studies Provide Meaningful Information About Breast Implant Safety?

There are three major problems with the breast implant studies submitted to the FDA.

#1. Most studies lost track of most patients, so that the results can’t tell us what “most women” will experience. The complication rate for “most women” could be much higher or much lower.

#2. Most of the studies didn’t ask patients about the kinds of health problems that many women with implants experience. And, the studies stop at 10 years, whereas many of the worst complications occur after more than 10 years.

#3. Some of the studies rely primarily on questionnaires filled out by the patients, rather than medical records or medical examinations. In medical research, medical examinations or medical records are considered much more accurate ways to evaluate a person’s health than questionnaires.

The FDA report includes several studies that the companies conducted and submitted as a requirement of FDA approval. The FDA has not stated how many of the studies relied on information from medical examinations and how many relied on questionnaires filled out by the patients. However, we know that the largest studies, which should be the most important ones, rely on questionnaires. The “Core” studies of breast implants have some good 8-10 year information about local complications (such as implant breakage) for breast cancer patients but very limited information about augmentation patients. Information is especially lacking for women with Mentor implants.

Studies that are called the “Adjunct studies” lost track of most of their patients and can’t provide useful information about complications of any type.

The Patients Did Not Stay in the Studies

The largest studies—the ones with more than 40,000 patients each conducted by Mentor and Allergan—have reported the first two or three years of data. Mentor already lost track of 79% of all their patients after three years. Allergan lost track of almost half their augmentation patients in their first two years, and 25-31% of their reconstruction patients in the first two years. These studies are supposed to continue for 10 years. Usually, if patients drop out of a study after 2 or 3 years, they won’t participate in the study after that. For that reason, a study that lost even 25% of their patients after only 2 years are likely to lose more than half by 5 years, and the majority by 10 years.

When even a third to a half of the patients drop out before the research is completed, it is impossible to say with confidence what percentage of women will need additional surgery or have health problems after getting breast implants. In research, this problem is called missing data or “loss to follow-up.” In most of the studies that the companies conducted, most of the patients did not provide follow-up health information in the years that the study was supposed to measure complications. Did the companies lose track of the patients because the patients no longer stayed in touch with their plastic surgeon? Did patients stop going to the doctor because their implants were removed? Were they “lost to follow-up” because they died or got very sick? Or are they so happy with their implants and their lives that they didn’t want to be bothered going back to the plastic surgeon or filling out questionnaires? The huge number of patients who are “missing” from many of these studies, and especially the Mentor studies, are such a problem that these results would not be publishable in any peer-reviewed journal.

Is the Safety Information Provided Accurate and Comprehensive?

Some women have told us that when they reported health problems to their plastic surgeons, those problems were not reported to the FDA as part of the studies. We don’t know how often this happens, but complications would be under-counted whenever that happens. Patients tell us that plastic surgeons have an interest in staying in touch when the patients are satisfied, but not when patients are having problems. This could result in many women with implant problems being “lost to follow-up,” and those health problems would therefore not be counted in the study results.

Another problem with these largest studies is that they rely on questionnaires that patients fill out online for payment. A patient that wants to receive the payment ($10 or $20) might fill out the questionnaire very quickly, and not necessarily carefully. And, even if the patient does her best to fill out the questionnaire accurately, she may not know the answers to some of the questions about diagnoses of a long list of diseases, most of which the patient may never have heard of and some of which are almost impossible to pronounce.

In addition, It seems that some of the studies did not ask about many of the complications that women with leaking implants have complained about in testimony before the FDA, such as joint pain, hair loss, and other autoimmune symptoms. By focusing on the diagnosis of rare diseases rather than on symptoms that are more likely, some of the studies seem designed to result in an “implants are safe” conclusion rather than a “complications can be devastating” conclusion.

Despite these shortcomings, the FDA concluded that the studies show that many women with implants have “frequent local complications and adverse outcomes.” However, the results could have been very different if the studies did not have the three major flaws listed above.

What Does the Breast Implant Safety Issue Tell Us about the FDA Post-Market Studies and Safety Data?

Once a medical product is approved, its manufacturers have no incentive to do required post-market studies properly. Silicone breast implants are just one example of how the FDA’s reliance on post-market studies to determine product safety can lead to inadequate safety data that have no practical value for a patient trying to decide whether to use a medical product. Most women considering silicone breast implants can have no way of knowing how likely they are to experience serious complications when studies are so poorly conducted.

What should the FDA do differently? It’s time for the FDA to acknowledge that studies done before approval are likely to be much better than the ones done afterwards. The FDA should require better information before approving a product, and should rescind approval if a company fails to provide adequate safety data after approval.

What Do Women Considering Breast Implants Need to Know about Implant Safety?

The FDA reminds us in this report that “breast implants are not lifelong devices.” Many patients need additional surgery and perhaps need to have their implants removed within a few years. They report that about half the reconstruction patients (those who get implants after cancer or trauma) need to have their implants removed (and possibly replaced) within 8-10 years. The FDA reported lower rates of removal (1 in 5 patients) in 8-10 years for augmentation patients, but are those lower numbers credible? We think that they are not credible because so many of the augmentation patients were not in the study after 8-10 years. We don’t even know if the women whose implants were removed were intentionally dropped from the study because they no longer had breast implants.

The FDA report also reminds us that breast implant complications are common. “The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), re-operation (additional surgeries) and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.” If a silicone gel implant leaks or ruptures, the silicone gel can migrate to the lymph nodes or organs where it can’t be surgically removed.

The FDA notes that “preliminary data” does not show a link between breast implants and autoimmune or connective tissue disease. “However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far,” the FDA admits. Although the FDA did not mention it, research indicates that autoimmune problems often decrease after breast implants are removed.

We recommend that women considering implants always make sure they have at least $6,000-8,000 saved to remove problem implants, in addition to the cost of the initial surgery. The FDA cautions women to “assume that you will need to have additional surgeries.” We have heard from many women who had serious health problems and were unable to remove their implants because they did not have enough money for surgery. While breast augmentation surgery is sometimes available on an installment plan, implant removal surgery is not.

Women considering implants can follow the link to read more information about breast implant safety.

What Do Women Who Have Silicone Gel Breast Implants Need to Know?

Because most women don’t notice when a silicone gel implant ruptures, the FDA reminds women with silicone gel breast implants to have breast MRIs regularly to detect ruptures that have no symptoms.  When silicone breast implants were first approved, the FDA recommended that all women undergo a breast MRI 3 years after getting breast implants, and every other year after that. However, because of the expense and the reluctance of plastic surgeons to encourage MRIs for silent ruptures, very few women followed the FDA’s advice.  As of October 2020, FDA now recommends an MRI 5-6 years after the initial surgery and every 2-3 years after that. Unfortunately, a breast MRI costs about $2,000 or more.  The FDA therefore warns that this procedure “is costly and may not be covered by your insurance.”

The FDA also tells women that “The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications.”

The FDA states that “…Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far.”

“At this time, the FDA is recommending that healthcare professionals and women who have silicone gel-filled breast implants do the following:

  • Follow Up.  Women should continue to routinely follow up with their healthcare professionals. This includes getting routine MRIs to detect silent rupture.
  • Be Aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring and infection.
  • Pay Attention to Changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or by calling 800-332-1088.
  • Stay In Touch. If a woman has enrolled in a manufacturer-sponsored post-approval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.”
    Women with silicone gel breast implants can follow the links to read more about silicone breast implant problems and what to do if your implant breaks.

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