Breast Implant Safety
What Patients Need to Know

Breast implants are FDA-approved devices for use in breast augmentation and breast reconstruction. Many women undergo these procedures successfully each year but, as with all devices, there are risks associated with breast implants that you should be aware of.

FDA-approved breast implants undergo initial, mandated testing to demonstrate reasonable assurance of safety and effectiveness. The FDA continues to monitor patient experiences with breast implants, review emerging safety data and communicate with patients and physicians as new risks arise.

As of 2020, the FDA currently recommends screening your breast implants with MRI or ultrasound beginning five to six years after silicone implant placement and every two to three years thereafter. Even if you do not have concerns about the condition of your implants, it is important to go for your routine screenings, based on the FDA-recommended timeline. Routine screenings can verify your implant is intact and identify complications such as implant rupture or silicone leakage. Although implant rupture can cause various symptoms, some women with ruptured implants experience no symptoms, which is why routine screenings are critical.

The majority of women with breast implants experience no serious complications. However, there are risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), breast implant-associated squamous cell carcinoma (BIA-SCC) and systemic symptoms commonly referred to as breast implant illness (BII). The information below will help you better understand the association between these devices and their risks.

As of November 27, 2021, the FDA requires all breast implant manufacturers to include a product-specific Patient Decision Checklist with each device. This checklist contains information on known or reported risks of breast implants. Your board-certified plastic surgeon will review the items in this document with you, along with other patient information forms, and you can talk carefully together about the benefits and risks of breast implants.

After you have discussed the checklist fully and feel confident you have all your questions answered, you can sign the checklist with your surgeon and receive a copy for your records.

Your surgeon will provide a patient decision checklist from the manufacturer that is specific to your breast implants, but you can review this example checklist endorsed by ASPS. This document is only a sample and not the actual device-specific checklist you will discuss and sign with your surgeon.

BIA-ALCL

BIA-ALCL stands for breast implant-associated anaplastic large cell lymphoma. It is an uncommon cancer that has been confirmed only in patients with breast implants that have a rough surface. These implants are known as textured implants. BIA-ALCL is not a cancer of the breast tissue. Instead, it is located in the scar tissue that naturally forms around the implant. This tissue is called the capsule.

BIA-ALCL is often curable if diagnosed and treated early, but there have been women whose initial diagnosis reveals the disease has already spread (metastasized) to their armpit lymph nodes or other parts of their bodies. When the disease is this far along, it can be more difficult to cure. In addition to capsulectomy and removal of the implants, women with advanced disease may require chemotherapy, radiation therapy or even stem cell transplantation. Unfortunately, some women have died from this disease. It is very important to seek treatment immediately if you discover swelling around your breast implant, a new breast/armpit lump or changes to your breast skin.

Understanding your risk

As of July 2019, literature reports various estimates for the incidence of BIA-ALCL. These estimated incidence rates range from a high of 1 per 3, 817 patients to 1 in 30,000. (Clemens et al, 2017, Loch-Wilkinson et al, 2017, De Boer et al, 2018)

Importantly, BIA-ALCL has been identified in patients with all types of textured implants and both breast cancer reconstruction and cosmetic patients.

To date, there are not any confirmed BIA-ALCL cases that involve only a smooth implant, but the medical records of many women diagnosed with BIA-ALCL did not specify whether their implants were textured. Currently, it is not possible to test for who is at risk of this disease.

Knowing the symptoms

Common symptoms include unexplained breast enlargement, pain, asymmetry, lump in the breast or armpit, overlying skin rash, hardening of the breast or a large fluid collection. For any patient experiencing these or any symptoms, they should see their doctor for evaluation.

Considering reconstruction with implants?

Breast cancer patients considering implant reconstruction should discuss the benefits and risks of different types of implants with their physician. There are many breast implant options such as smooth, textured, round, shaped, saline and both liquid and solid silicone. A physician may suggest a certain implant shape, surface and fill to achieve an optimal reconstruction while minimizing potential complications. BIA-ALCL is an emerging risk of textured implants and patients should be aware when choosing the implant that is right for them.

Have you developed symptoms?

Women who develop the symptoms of BIA-ALCL should see their physician to be evaluated with a physical exam and further testing.

1. Schedule a follow-up appointment with your treating physician to discuss any concerns you may have about your breast health or implants.
2. Following a physical examination, patients with BIA-ALCL symptoms may receive an ultrasound or magnetic resonance imaging (MRI) of the symptomatic breast to evaluate for fluid or lumps around the implant and in the lymph nodes.
3. If fluid or a mass is found, patients will require a needle biopsy with drainage of the fluid to test for BIA-ALCL. This fluid will be tested for CD30 immune staining (CD30 IHC) performed by a pathologist. Testing for CD30 IHC is required to confirm a diagnosis or rule out BIA-ALCL. Fluid collections ruled out by CD30 IHC for BIA-ALCL will be treated as typical seromas by a physician. Specimens not testing for CD30 may miss the diagnosis of BIA-ALCL.

Have you been diagnosed with BIA-ALCL?

Receiving a diagnosis of cancer is inevitably frightening, and you may experience a range of emotions, including anger. Everyone's experience is different, but when found early, BIA-ALCL is curable in most patients.

ASPS endorses BIA-ALCL guidelines established by the National Comprehensive Center Network (NCCN), which defines diagnosis and treatment based on proven methods to treat the disease.

Step-by-step treatment of BIA-ALCL

1. When a woman is diagnosed with BIA-ALCL, her physician will refer her for a PET/CT scan to look for any disease that may have spread throughout the body. Any spread of the disease determines the stages, which is important for determining treatments and predicting how successful that treatment may be.
2. Newly diagnosed patients will be referred to an oncologist for evaluation of BIA-ALCL, staging of the disease and treatment planning.
3. For patients with BIA-ALCL only around the implant, surgery is performed to remove the breast implant and the scar capsule around the implant.
4. Lumps in the armpit may be a disease that has spread to the lymph nodes or may still be a normal enlargement of the lymph nodes. Testing of the lymph nodes may be performed with a needle biopsy or with surgery to remove a lymph node for testing. Additional tests may sometimes include blood tests and a bone marrow biopsy.
5. Some patients with advanced cases that have metastasized, or spread to distant parts of the body, will require further treatment. This may include chemotherapy and in rare cases include radiation therapy and/or stem cell transplant therapy.

After treatment

For women with early-stage cancer, following removal of the disease, patients are commonly followed for two years with imaging tests for three to six months. Disease reoccurrence is rare after surgical removal for early disease, but can occur and it's important to detect recurrences as soon as possible

Reporting of confirmed cases

The U.S. Food and Drug Administration (FDA) specifically recommends that all confirmed cases be reported to the PROFILE registry. The PROFILE registry is a joint effort of the FDA and ASPS/PSF. If you have been diagnosed with BIA-ALCL, please ensure your physician has reported the case to the PROFILE registry for tracking of cases. Information reported to PROFILE is updated with the FDA on a monthly basis. While PROFILE is a physician reporting system, if you would like to report your case directly, you may contact PSF who can get you in contact with a physician willing and able to report your case.

BIA-SCC

On March 8, 2023, the FDA released an update to its September 2022 safety communication about squamous cell carcinoma (SCC) and various lymphomas in the capsule around breast implants. ASPS additionally provided its members more specific information about BIA-SCC. BIA-SCC stands for breast implant-associated squamous cell carcinoma. It is a very rare, but potentially aggressive tumor that appears to be associated with breast implants. ASPS/PSF is currently aware of only 19 reported cases in the published literature. BIA-SCC is not breast cancer. Instead, it is located in the scar tissue that naturally forms around the implant. This tissue is called the capsule.

Many women have already heard of BIA-ALCL and know that it is associated with textured implants and the withdrawn Biocell textured implants and expanders. BIA-SCC is a different disease. It is important to know that it does not appear to be associated exclusively with textured implants, and the FDA does not currently recommend any change in your routine breast care.

What is BIA-SCC?

BIA-SCC is not a cancer of the breast tissue itself. Pathology shows squamous cells lining the capsule. Though this is a very rare tumor, BIA-SCC can spread to local tissues, such as muscle and bone. It can also spread to lymph nodes and distant sites (i.e., lung, liver etc.).

Hearing the words "squamous cell carcinoma" in relation to breast implants may be confusing, since many of us only know about this as a kind of skin cancer. More research and ongoing and persistent surveillance of breast implants is necessary to learn more.

Understanding your risk

ASPS/PSF is currently aware of so few reported cases of BIA-SCC that it is not yet possible to determine what factors might increase your risk. The 16 cases of BIA-SCC that have been reported in the published literature are in patients with different types of implants – silicone and saline, smooth and textured. It has appeared in women who have had implants because of breast cancer reconstruction and for cosmetic reasons.

Cases of BIA-SCC seem to appear later, as compared to BIA-ALCL. The average length of time from initial implantation to diagnosis is about 22 years for BIA-SCC. The average length of time from initial implantation to diagnosis is about 11 years for BIA-ALCL.

Knowing the symptoms

Common BIA-SCC symptoms mimic those of BIA-ALCL and include unexplained breast enlargement, pain, asymmetry, lump in the breast or armpit, overlying skin rash, hardening of the breast or a large fluid collection. Any patient experiencing these, or any symptoms, should see her doctor for evaluation.

Have you developed symptoms?

Women who develop symptoms that could signal either BIA-SCC or BIA-ALCL should see their physician to be evaluated with a physical exam and further testing. Preoperative testing that includes both imaging and a needle biopsy is important.

1. Schedule a follow-up appointment with your treating physician to discuss any concerns you may have about your breast health or implants.
2. Following a physical examination, patients with BIA-SCC and BIA-ALCL symptoms may receive an ultrasound or magnetic resonance imaging (MRI) of the symptomatic breast to evaluate for fluid or lumps around the implant and in the lymph nodes.
3. If fluid or a mass is found, patients will require a needle biopsy with drainage of the fluid to test for BIA-SCC. The fluid can be tested for BIA-SCC and BIA-ALCL at the same time. For BIA-SCC specifically, the fluid will be tested for CK 5/6 and p63. Flow cytometry for squamous cells and keratin will also be performed by a pathologist (see below for the tests your doctor will order for BIA-ALCL). Fluid collections ruled out for BIA-SCC and BIA-ALCL will be treated as typical seromas by your physician. Specimens not testing for CK 5/6, p63 and flow cytometry for squamous cells and keratin may miss the diagnosis of BIA-SCC, so it is important that these tests are performed.

Have you been diagnosed with BIA-SCC?

Hearing about this new type of cancer (even if it is very rare) or receiving a diagnosis is frightening, and you may experience a range of emotions, including anger. Everyone's experience is different, and ASPS recommends that you consult your plastic surgeon about the right course of surgical treatment for you.

There are no official treatment guidelines for BIA-SCC yet. These will need to be developed as data emerges. But to help guide your overall thinking about the treatment process, we can use the framework of the BIA-ALCL guidelines established by the National Comprehensive Center Network (NCCN). This information may change as more information becomes available.

Step-by-step treatment of BIA-SCC

1. After a woman is diagnosed with BIA-SCC, her physician will refer her for an MRI with and without contrast to evaluate the capsule. An additional PET/CT scan to look for any disease that may have spread throughout the body. Preoperative imaging will allow your surgeon to plan for a single-stage surgery with the greatest chance of success for cure.
2. Newly diagnosed patients will be referred to an oncologist for evaluation of BIA-SCC staging of the disease and treatment planning.
3. For patients with BIA-SCC, right now, it appears that total removal of the breast implant and scar capsule around the implant (en bloc capsulectomy) will most likely be necessary.
4. Lumps in the armpit may be a disease that has spread to the lymph nodes or may still be a normal enlargement of the lymph nodes. Testing of the lymph nodes may be performed with a needle biopsy or with surgery to remove a lymph node for testing. Additional tests may sometimes include blood tests and a bone marrow biopsy.
5. Some patients with advanced cases that have metastasized, or spread to distant parts of the body, will require further treatment. Your doctors will talk with you about appropriate chemotherapy and/or radiation.

After treatment

Following removal of the tumor, patients are commonly followed for multiple years with imaging tests.

Reporting of confirmed cases

Soon, all confirmed or suspected cases of BIA-SCC will be able to be reported to the PROFILE registry. The PROFILE registry is a joint effort of the FDA and ASPS/PSF that was created to collect data on BIA-ALCL. The Foundation is expediting work to have data points related to BIA-SCC included. Information reported to PROFILE is updated with the FDA on a monthly basis. While PROFILE is a physician reporting system, if you would like to report your case directly, contact The PSF to be connected with a physician willing and able to report your case.

BII

Breast implant illness is the name for a broad cluster of symptoms that researchers, physicians and patients attribute to breast implants. These symptoms may occur either immediately after getting implants or years later.

They may include joint and muscle pain or weakness, memory and concentration problems, chronic pain, depression, fatigue, chronic flu-like symptoms, migraines or rashes and skin problems.

Diagnosing breast implant illness may be difficult since some of these symptoms are quite common and could be caused by other exposures or diseases. Although it may be hard to establish a causal link between BII and breast implants for any individual patient, researchers are working to better understand which women are more likely to develop these symptoms as a result of their implants. Even if your symptoms seem difficult to categorize, it is important for your physician to conduct a full evaluation. For your own peace of mind, you may also wish to seek a second opinion.

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

Have you developed symptoms?

Women who develop these or other symptoms should see their board-certified plastic surgeon or physician/specialist to be evaluated with a physical exam and further testing.

What should I expect my plastic surgeon or specialist to do?

So far, there is no diagnostic test for breast implant illness. Instead, your doctor will try to rule out inflammatory or autoimmune diseases that might be causing your symptoms. Because the symptoms of BII may overlap with other conditions, your doctor may order blood tests or work with a specialist to try to eliminate other possible causes before recommending treatment or implant removal.

Insurance does not always cover the costs for these tests, so it is important to know that these may be at your own expense.

What if I decide that removing my implants is best for me?

It is your decision to have breast implants placed, and it is your decision to have breast implants removed. You should discuss your best options for explantation with your board-certified plastic surgeon. This might be another area where a second opinion is helpful.

What is ASPS doing to support patients?

ASPS will soon publish research that establishes a list of symptoms most frequently associated with BII with consensus from patient research partners, surgeons, researchers and regulators. Increased understanding is necessary to better address patient concerns, provide evidence-based care and inform prospective patients about potential risks.

ASPS and PSF are currently funding the next stage of work by these same researchers, which will support the development of tools for patients to report their experience of any symptoms associated with breast implant illness.

Reporting of cases

ASPS encourages patients to report any injury, adverse event or symptom related to a medical device, including the symptoms listed above, to the FDA by phone at (800) FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program. Please include the following information:

• Device Name (Brand Name)
• Manufacturer's Name
• Details of Adverse Event and Medical and/or Surgical Interventions (if applicable)

Registries

A clinical data registry is an interactive database that collects, organizes and displays healthcare information for many purposes and uses. They are sometimes called patient registries or disease registries.

Why do registries matter?

The American Society of Plastic Surgeons and The Plastic Surgery Foundation have developed several registries that work together to advance patient safety and research. These registries are not available to the public. Currently, only physicians have the ability to enter cases or review their practice's data, but ASPS does publish registry reports in peer reviewed journals and on its website.

• Analysis of registry data helps to identify trends or patterns in treatment and outcomes. These data-driven insights can help highlight best practices and the development of evidence-based medical treatment decisions.
• Patient input in a registry about their health status and the care they receive for a specific disease or condition can help support research and therapeutic developments.
• Medical device manufacturers and pharmaceutical developers use registries to track and understand the effectiveness, safety and value of medical devices or therapies and drugs entering or on the market.
• For rare diseases (like BIA-ALCL), registries are extremely valuable as they enable organizations to gather a sufficient amount of information from many sources for researchers and clinicians to learn about a disease.

Which ASPS registries support breast surgery patients?

NBIR

In collaboration with the FDA and breast implant manufacturers, ASPS and The PSF launched the National Breast Implant Registry (NBIR) in September 2018 to collect information on breast implant procedures to help improve the quality of care for all patients.

Research takes time, which is why the NBIR is important. The NBIR collects information on breast implant procedures – patient demographics, surgical techniques, types of devices, etc. – and the information will be used to improve the quality of care for all patients.

The NBIR is designed to find trends in breast implant procedures and devices, by following the life-cycle of the breast implant. This can also help identify potential complications, so breast implant manufacturers can use the information to further study the safety of their products. For more information, please visit ThePSF.org/NBIR.

PROFILE

In collaboration with the FDA, ASPS and The PSF launched the PROFILE registry in 2011 to increase the scientific data on BIA-ALCL in women with breast implants. As of March 2023, plastic surgeons and other health care providers can also submit cases of BIA-SCC and other lymphomas and cancers in the capsule around breast implants to PROFILE.

The primary goal of PROFILE is to better understand the role of breast implants in the etiology of BIA-ALCL, BIA-SCC and other cancers in the capsule around the breast implant. The research also will focus on identifying potential risk factors and criteria detection and management of this disease.

PROFILE data is routinely reviewed and analyzed. Data summaries comparing PROFILE data to FDA data are performed monthly and are available online to the public. In 2019, the first PROFILE manuscript containing an in-depth data analysis was published in PROFILE manuscript containing an in-depth data analysis was published in Plastic and Reconstructive Surgery.

For more information, please visit ThePSF.org/PROFILE.