Breast implants are medical devices implanted under the breast tissue or chest muscle to increase breast size (augmentation) or to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality (reconstruction). They are also used in revision surgeries, which seek to correct or improve the result of an original surgery.

There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour).

Saline-filled breast implants contain a silicone outer shell filled with a sterile saltwater (saline) solution. Some are pre-filled and others are filled during the implant operation. Saline-filled implants come in different sizes and have either smooth or textured shells. The FDA approved saline-filled breast implants for breast augmentation in women age 18 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.

Summary of Safety Information:

Breast implants are not lifetime devices. The longer a woman has implants, the more likely it is that she will need to have surgery to remove them.

The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture with deflation, wrinkling, asymmetry, scarring, pain, and infection. In addition, women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).

There is no apparent association between saline-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, in order to rule out these and other complications, studies would need to be much larger and longer than those conducted so far.

Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

Silicone gel-filled breast implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.

Summary of Safety Information:

Breast implants are not lifetime devices. The longer a woman has implants, the more likely it is that she will need to have surgery to remove or replace them. The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture with deflation, wrinkling, asymmetry, scarring, pain, and infection. In addition, women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).

Magnetic resonance imaging (MRI) continues to be the most effective method of detecting silent rupture of saline- and silicone gel-filled breast implants.

There is no apparent association between saline- and silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, to rule out these and other complications, studies would need to be much larger and longer than those conducted so far.

In June 2011, the FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. This update included preliminary results of the studies required by the manufacturers at the time of approval as well as a review of other available scientific data.

The Summary of Safety and Effectiveness for each of the FDA-approved saline- and silicone gel filled breast implants details safety information known at the time of FDA approval. As the FDA learns of new safety information, it requires companies to update their product labeling. The most current safety information about saline- and silicone gel-filled breast implants can be found in the labeling.

Breast reconstruction may be performed after mastectomy, to rebuild injured or congenitally deformed breasts, or as part of gender reassignment surgery. As part of the reconstruction process, a breast tissue expander may be used to stretch the patient's tissue for insertion of an implant or the patient's own tissue. Tissue expanders are like thick-walled silicone balloons, come in different sizes and shapes, and may have a smooth or textured outer surface. They are implanted under the breast skin, tissue, or chest muscle, and are regulated by the FDA as medical devices. In immediate reconstruction, the expander is inserted immediately following mastectomy. For patients who choose delayed reconstruction, the expander is implanted in a separate surgery months or years later.

Once the surgical incision is healed, the tissue expander is "inflated" during the course of weeks to months. Inflation may be through a series of saline solution injections at the health care provider's office, or through a patient-controlled device that releases carbon dioxide gas into the expander.

Because expanders are temporary medical devices, an expander is not intended to remain in place for more than six months. When expansion is complete, a new surgical procedure is performed to remove the expander and insert a breast implant or the patient's own tissue.

There are some risks in using tissue expanders. The use of tissue expanders may result in breast tissue injury and skin thinning, pain, especially during saline filling, and infection. The expander may rupture, and the site or port for saline injection may become infected.

Implants are inserted underneath the skin or chest muscle following the mastectomy. (Most mastectomies are performed using a technique called skin-sparing mastectomy, in which much of the breast skin is saved for use in reconstructing the breast.)

Implants are usually placed as part of a two-stage procedure.

• In the first stage, the surgeon places a device, called a tissue expander, under the skin that is left after the mastectomy or under the chest muscle. The expander is slowly filled with saline during periodic visits to the doctor after surgery.
• In the second stage, after the chest tissue has relaxed and healed enough, the expander is removed and replaced with an implant. The chest tissue is usually ready for the implant 2 to 6 months after mastectomy.

In some cases, the implant can be placed in the breast during the same surgery as the mastectomy—that is, a tissue expander is not used to prepare for the implant.

Surgeons are increasingly using material called acellular dermal matrix as a kind of scaffold or “sling” to support tissue expanders and implants. Acellular dermal matrix is a kind of mesh that is made from donated human or pig skin that has been sterilized and processed to remove all cells to eliminate the risks of rejection and infection.

There are several important things to consider before deciding to undergo any breast implant surgery. Below are some things the FDA thinks you should consider before undergoing breast augmentation, reconstruction or revision surgery.

• The sale and distribution of breast implants are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling provided by each manufacturer.
• Breast implants are not lifetime devices. The longer you have your implants, the more likely it will be for you to have them removed or replaced.
• You should assume that you will need to have additional surgeries (reoperations) because breast implants are not lifetime devices and complications can occur.
• Even if you have complications, the cost of implant removal or implant replacement may not be covered by insurance.
• The longer you have breast implants, the more likely you are to experience complications and adverse outcomes, which may be cosmetically undesirable and irreversible.
• The most common local complications and adverse outcomes are capsular contracture, reoperation and implant removal. Other local complications include rupture or deflation, wrinkling, asymmetry, scarring, pain, and infection at the incision site. For a more complete list of complications and adverse outcomes that may occur for a specific breast implant, you should ask your surgeon for the manufacturer's patient labeling and educational materials or review the relevant labeling.
• Read the manufacturer's patient labeling and other educational materials carefully and discuss any questions you have with your surgeon before deciding.
• There are different shapes, styles and textures of breast implants. Discuss your goals and expectations and the benefits and risks of breast implants with your surgeon.
• If you have your implants removed but not replaced, you may experience changes to your natural breasts such as dimpling, chest wall concavity, puckering, wrinkling, breast tissue loss, or other undesirable cosmetic changes.
• Breast implants need to be monitored for as long as you have them. If you have silicone gel filled breast implants, your health care provider may recommend that you have regular exams using magnetic resonance imaging (MRI) or ultrasound that may not be covered by your insurance, to screen for breast implant rupture and other complications.
• If you notice any abnormal changes in your breasts or implants, you will need to see your surgeon or health care provider promptly.
• There is a risk of developing a type of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the breast or scar tissue (capsule) surrounding the implant. BIA-ALCL is not breast cancer. Treatment of BIA-ALCL involves removal of the implant and the capsule surrounding the implant. Some patients have also required chemotherapy and/or radiation therapy
• Although treatable, there is a risk of death for patients diagnosed with BIA-ALCL.
• Some breast implant patients report a variety of systemic symptoms, such as chronic fatigue, brain fog, joint and muscle pain, which may not meet the diagnostic criteria to be categorized as a disease. Patients refer to these symptoms collectively as "breast implant illness (BII)." In some cases, patients report that removal of their breast implants without replacement appears to reverse their symptoms.
• Breast reconstruction often involves the implantation of not only a breast implant device but also a surgical mesh device. Implanting surgical mesh as part of breast implant surgeries has not been approved by the FDA.

Breast implant surgery can be performed in a hospital or surgery center. Breast implant surgery patients may have to stay overnight in the hospital (inpatient surgery) or may be able to go home afterward (outpatient surgery). The surgery can be done under local anesthesia, where the patient remains awake and only the breast is numbed to block the pain, or under general anesthesia, where medicine is given to make the patient sleep. Most women receive general anesthesia for this surgery. Breast implant surgery can last from one to several hours depending on the procedure and personal circumstances.

If the surgery is done in a hospital, the length of the hospital stay will vary based on the type of surgery, any complications after surgery, and your general health. The length of the hospital stay may also depend on the type of coverage your insurance provides.

Surgical Mesh and Breast Surgery

Surgical mesh is typically a flexible, thin flat sheet, usually made of nondegradable synthetic materials, biodegradable synthetic materials, or from animal- or human-derived tissues called acellular dermal matrices (ADM). Surgical mesh is a medical device, regulated by the FDA.

The FDA has not cleared or approved any surgical mesh for use with breast implants or in breast reconstruction, and thus has not reviewed potential benefits and risks for these uses. The FDA recommends that patients discuss the benefits and risks of mesh with their health care providers.

Surgical Consultation

Before surgery you should have a consultation with your surgeon. Be prepared to ask questions about the surgeon's experience, your surgery and expected outcomes. The surgeon should be able to discuss whether you are a good candidate for breast implants, the different type of implants, options for size, shape, surface texture, and placement based on your particular circumstances, as well as the risks and benefits of implant surgery. The surgeon should also be able to provide you with before and after pictures of other patients to help you better understand your expectations and potential outcomes from surgery.

During the consultation you will need to discuss your medical history, including any medical conditions or drug allergies you may have. You should also discuss any previous surgeries you've had, especially to the breast, and what drugs you are currently taking, including supplements, herbal and over-the-counter (OTC) medications. It is important to tell the surgeon if you think you may be pregnant.

If you are undergoing breast implant surgery for reconstruction, you will also need to speak with your surgeon about your personal circumstances, including being treated with chemotherapy and/or radiation therapy, as these can affect your risks of complication and the appearance of the reconstructed breast. The surgeon should also speak to you about the amount of breast tissue that will remain after surgery and future screening for breast implant ruptures and breast cancer.

During the consultation, be sure to ask the surgeon for a copy of the patient labeling for the breast implant she or he plans to use. This should include a patient booklet/brochure that includes important information about your specific breast implant, as well as a boxed warning and patient decision checklist. You have the right to request this information, and your physician is expected to provide it.

Be sure to read the patient labeling entirely prior to surgery. Please know that this patient labeling is intended to enhance, but not replace, the discussion you have with your physician about the benefits and risks of breast implants as they uniquely pertain to you.

After reviewing the information in the patient booklet/brochure for the specific implant that will be used, please read and discuss the items in the checklist carefully in consultation with your physician. You should place your initials in the location provided next to each item to indicate that you have read and understood the item and that your physician has answered all questions to your satisfaction. In addition, please make sure you read and understand the informed consent form before you sign it.  If you decide to proceed with the surgery, your physician should also provide you with a patient device card after your surgery that has information on each of your specific implants.

Breast implant manufacturers may be conducting clinical studies to evaluate breast implants and to understand the long term experiences of women who receive breast implants. If you are interested in participating in a clinical study, be sure to ask your surgeon what specific steps you will need to take.

Questions to Ask Your Doctor Before Having Breast Implant Surgery

When choosing a surgeon for a breast implant procedure, you may want to consider their years of experience, their board certification, their patient follow-up, and your own comfort level with the surgeon. Most breast implant procedures are performed by board-certified plastic and reconstructive surgeons. The following questions can help guide your discussion with your surgeon regarding breast implant surgery.

Questions to Ask...

About Your Surgeon

1. How many breast implant procedures do you do each year?
2. What percentage of your practice is dedicated to breast augmentation? To breast reconstruction?
3. What type of implants do you use? Saline or silicone? What is your experience with each?
4. What is the most common complication you encounter with breast implant surgery?
5. What is your rate of complications in general (capsule contracture, infection, etc.)?
6. What is your reoperation rate?
7. What is the most common type of reoperation you perform?

About Breast Implants and Expected Outcomes

1. What shape, size, and surface texture are you recommending for my implants?
2. Why are you recommending one type of breast implant over another? Why do you recommend this one for me?
3. How long will my breast implants last?
4. What incision site and placement are you recommending for me?
5. Do you have before and after photos I can look at for each procedure?
6. What results are reasonable for me to expect?
7. How will breast implants feel? Will they alter my breast skin or nipple sensation?
8. What are the risks and complications associated with having breast implants?
9. Can I still get breast implants for augmentation if I have a strong family history of breast cancer?
10. How many additional operations on my breast implants can I expect to have over my lifetime?
11. How will I be able to tell if my breast implant has ruptured or if there is a problem with my breast implants?
12. How will my breasts look if I decide to have the implants removed and not replaced?
13. How easy or difficult is it to remove the implants?
14. How easy or difficult is it to increase the size of the implants after the breast implants have been placed?
15. What can I expect my breasts to look like over time? What do I need to do to maintain them?
16. What kind of additional follow-up will I need?
17. What are the long-term consequences of breast implants?
18. What will my breasts look like after pregnancy? After breastfeeding?
19. Will the breast implants affect my ability to breastfeed a baby?
20. What are my options if I am dissatisfied with the outcome of my breast implants?
21. Can I still get mammograms with breast implants in place?
22. Will the mammogram rupture my breast implant?
23. What alternate procedures or products are available besides breast implants?

About the Breast Implant Operation

1. How long will I be in pain after the surgery?
2. What is my expected recovery time?
3. Will I need help at home for normal activities after the surgery and if so for about how long?
4. How long do you expect my operation to take?
5. What (if any) secondary procedures associated with my breast augmentation/breast reconstruction will be required?
6. How likely is it that I will get an infection after the surgery?
7. How much risk is there from the anesthesia?
8. What can I do to minimize the risk of short-term and long-term complications?
9. Where will my scar be?

Risks of Breast Implants

Some of the complications and adverse outcomes of breast implants include:

• Implant complications, such as breast pain and changes in nipple and breast sensation
• Additional surgeries, with or without removal of the device 
• Capsular contracture, scar tissue (capsule) that forms around the implant and squeezes the implant
• Rupture and deflation
• Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma (cancer of the immune system)
• Connective tissue disease, breast cancer, and reproductive problems
• Systemic symptoms
• Breastfeeding
• Effects on children

Implant Complications

The following is a list of local complications and adverse outcomes that occur in at least 1 percent of breast implant patients at any time. You may need non-surgical treatments or additional surgeries to treat any of these, and you should discuss any complication and necessary treatment with your doctor. These complications are listed alphabetically, not in order of how often they occur.

Additional Surgeries

Breast Implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. There is no guarantee that you will have a satisfactory cosmetic outcome from any reoperation.

The type of surgical procedure performed during a reoperation depends on the complication involved. You may need to have one or more reoperations over the course of your life due to one complication or a combination of local complications. More than one procedure may be performed in a single reoperation. Types of surgical procedures that may be performed in a reoperation include:

• Implant removal, with or without replacement
• Capsule removal or surgical release of the scar tissue around the breast implant
• Scar or wound revision, such as surgical removal of excess scar tissue
• Drainage of a hematoma by inserting a needle or tube through the skin to drain the collection of blood
• Repositioning of the implant by surgically opening the incision and moving the implant
• Biopsy/cyst removal by inserting a needle through the skin or cutting through the skin to remove a lump.

Implant Removal Options

If you elect to have your breast implants removed, or if it is medically indicated, there are two primary methods for implant removal. Your plastic surgeon may choose to remove your implant alone and leave the scar tissue that surrounds your implant in your body, also called the scar capsule. This option requires less surgical dissection and may pose less risk of local complications such as bleeding. Alternatively, your surgeon may also surgically remove the scar capsule when your breast implant is removed. This is called "en-bloc resection". You should discuss with your surgeon which method is best for your situation.

If you experience any symptoms of BIA-ALCL, such as persistent swelling or pain, or other changes in the area around your breast implant, talk to your surgeon or health care provider about the need for further evaluation. Evaluation for BIA-ALCL typically involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. It is important to have an evaluation to diagnose BIA-ALCL because a confirmed BIA-ALCL diagnosis may change the type of operation that should be performed.

Generally, patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone. Talk to your surgeon about the method of removal most appropriate for you.

Removal of a breast implant, with or without replacement, is one type of reoperation. The life of breast implants varies by person and can't be predicted. You may need to have your implant removed at some time over the course of your life because of one or more local complications.

After removal, some women do not choose to replace their implants. These women may have cosmetically undesirable dimpling, chest wall concavity, puckering, or sagging of their natural breasts.

The photograph below shows a 29-year-old woman 1 year after having her silicone gel-filled breast implants removed, but not replaced. Women with large breast implants, especially those inserted on top of the chest muscles (subglandularly), may have major cosmetic deformity if they choose not to replace them or to undergo additional reconstructive surgery.

Some insurance companies do not cover implant removal or implant replacement, even if there are complications and even if the first implant surgery was covered.

Capsular Contracture

Capsular contracture is the hardening of the breast around the implant. It can occur in the tissue surrounding one or both implants. This hardening causes the tissue to tighten, which can be painful.

Capsular contracture may be more common following infection, hematoma and seroma. However, the cause of capsular contracture is not known.

There are four grades of capsular contracture, known as Baker grades.

Baker Grading Scale

• Grade I: Breast is normally soft and looks natural
• Grade II: Breast is a little firm but looks normal
• Grade III: Breast is firm and looks abnormal
• Grade IV: Breast is hard, painful, and looks abnormal

Grades III and IV capsular contracture are considered severe and may require reoperation. The surgical procedure usually involves removal of the implant with or without replacement of the implant. There is a possibility that capsular contracture could occur again after surgery to correct it.

The FDA has not cleared or approved any devices to treat or reduce the incidence of capsular contracture.

The picture below shows a Grade IV capsular contracture in the right breast of a 29-year-old woman 7 years after placement of silicone gel-filled breast implants.

Rupture and Deflation

Rupture is a tear or hole in the outer shell of the breast implant.

Some possible causes of rupture of breast implants include:

• Capsular contracture
• Compression during a mammogram
• Damage by surgical instruments
• Damage during procedures to the breast, such as biopsies and fluid drainage
• Normal aging of the implant
• Overfilling or underfilling of saline-filled breast implants
• Physical stresses such as trauma or intense physical pressure
• Placement through a non-FDA approved incision site, for example the belly button
• Too much handling during surgery

Saline-Filled Breast Implant Rupture and Deflation

The term rupture is used for all types of breast implants, but the term deflation is only used for saline-filled implants. You and/or your doctor will be able to tell if your saline-filled implant ruptures because the saline solution leaks into your body immediately or over several days and deflates the implant. You will notice that your implant loses its original size or shape.

The following surgical procedures are not recommended for FDA-approved saline-filled breast implants because they are known to cause rupture and deflation:

• Closed capsulotomy - a technique used to relieve capsular contracture involving manually squeezing the breast to break the hard capsule
• Placement of drugs or other substances inside the implant other than sterile saline
• Any contact of the implant with Betadine, a povidone-iodine topical antiseptic made by Purdue Frederick Company
• Injection through the implant shell
• Alteration of the implant
• Stacking of the implants (more than one implant per breast pocket).

The photograph below shows a 30-year-old woman whose left saline-filled breast implant deflated. The implant is thought to have deflated due to a particular design, which is no longer used by the manufacturer.

Silicone Gel-Filled Implant Rupture

Silicone breast implants can rupture at any time after your implant surgery, but the longer an implant is in place, the greater the possibility an implant may rupture.

If a silicone gel-filled breast implant ruptures, it is not likely that you or your doctor will immediately notice because most silicone implant ruptures are without symptoms, "silent ruptures". A silent rupture doesn't change the way an implant looks or feels, and your surgeon or health care provider may not be able to detect a silent rupture by a physical examination alone. Magnetic resonance imaging (MRI) is the most effective method for detecting silent rupture of silicone gel-filled breast implants.

However, occasionally when a silicone gel-filled implant ruptures, a woman may notice a decrease in breast size, change in breast implant shape, hard lumps over the implant or chest area, an uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation.

Generally, when silicone gel-filled implants rupture, the silicone gel escapes through a tear or hole in the implant shell but remains confined within the scar tissue capsule around the implant, called an intra-capsular rupture. If the gel migrates beyond the scar tissue around the breast implant, it is called an extracapsular rupture. Sometimes, after a rupture, the gel may move to other distant areas around the body, which is called extracapsular rupture with gel migration. It may be difficult to remove silicone gel after a rupture.

Connective Tissue Disease, Breast Cancer, and Reproductive Problems

The FDA has not detected any association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, the FDA has received reports of systemic symptoms (see below) by some patients with both saline and silicone gel-filled breast implants. In order to fully understand these complications, studies would need to be larger and longer than those conducted so far.

Systemic Symptoms [Breast Implant Illness (BII)]

Symptoms such as fatigue, memory loss, rash, "brain fog," and joint pain may be associated with breast implants. Some patients may use the term "breast implant illness" (BII) to describe these symptoms. Researchers are investigating these symptoms to better understand their origins. These symptoms and what causes them are poorly understood. In some cases, removal of the breast implants without replacement is reported to reverse symptoms of breast implant illness.

We encourage 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 1-800-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)

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a T-cell lymphoma that can develop following breast implants. 

Understanding Patients’ Preferences

Patients’ voices, preferences and perspectives are critical to understanding the impact medical devices have on their conditions and their quality of life. The FDA’s Center for Devices and Radiological Health (CDRH) announced plans to study how patients weigh the benefits and risks associated with smooth and textured breast implants including the risk of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which appears more often in patients with textured breast implants.

In September 2020, CDRH contracted with Research Triangle Institute (RTI) International to conduct this study. To ensure the study prioritized the needs and experiences of patients, CDRH and RTI designed the survey tool based on input from focus groups made up of patients considering, or having had, breast reconstruction or augmentation using breast implants, as well as input from health care providers.

CDRH expects the survey results will help assess whether patients’ perception of risks of BIA-ALCL associated with textured breast implants are influenced by information about potential benefits of textured breast implants.

The insights gained through this patient-centered approach will help incorporate patient preferences in CDRH’s regulatory decision-making. CDRH is working to publish the results of this study in a peer-reviewed publication. We will continue to update the public when more information is available.

Breastfeeding

Some women who undergo breast augmentation can successfully breastfeed and some cannot. Women who undergo mastectomies and then have breast implant reconstruction surgeries may not be able to breastfeed on the affected side due to loss of breast tissue and the glands that produce milk.

Effects on Children

At this time, it is not known if a small amount of silicone may pass through from the breast implant silicone shell into breast milk during breastfeeding. Although there are currently no established methods for accurately detecting silicone levels in breast milk, a study measuring silicon (one component in silicone) levels did not indicate higher levels in breast milk from women with silicone gel-filled implants when compared to women without implants.

In addition, concerns have been raised regarding potential damaging effects on children born to mothers with implants. Two studies in humans have found no increased risk of birth defects in children born to mothers who have had breast implant surgery. Although low birth weight was reported in a third study, other factors (for example, lower pre-pregnancy weight) may explain this finding.

Q1. What does the FDA know about Breast Implant Associated Lymphoma?
A1. The FDA first identified a possible association between breast implants and the development of ALCL in 2011. At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk. In a report summarizing the Agency's findings, we emphasized the need to gather additional information to better characterize ALCL in individuals with breast implants. In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants and noted that the exact number of cases remained difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data.

Since that time, the FDA has undertaken several steps to better understand this issue, including an in-depth review of post-approval study data, medical device reports, scientific literature and breast implant-specific registries, and public discussions. We have regularly communicated about the risks associated with breast implants and heard from patients who are concerned about their implants being connected to various health conditions. In March 2019, we discussed many important breast implants concerns in a public advisory committee meeting.

Q2. What is BIA-ALCL? Is BIA-ALCL breast cancer?
A2. Breast Implant Associated Lymphoma (BIA-ALCL) is not breast cancer - it is a type of non-Hodgkin's lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. An individual's risk of developing BIA-ALCL is considered to be low; however, this cancer is serious and can lead to death, especially if not treated promptly. In most patients, it is treated successfully with surgery to remove the implant and surrounding scar tissue, and in some patients, also treatment with chemotherapy and radiation therapy.

Q3. What are the symptoms of BIA-ALCL?
A3. The main symptoms of BIA-ALCL are persistent swelling, presence of a mass or pain in the area of the breast implant. These symptoms may occur well after the surgical incision has healed, often years after implant placement.

Upon evaluation by a health care provider, evidence of fluid collection around the breast implant (seroma) is often observed. Some patient reports indicated that a lump under the skin or capsular contracture (thick and noticeable scar capsule around the implant) were present.

Q4. Where in the breast has BIA-ALCL been found?
A4. In the case studies reported in the literature, BIA-ALCL is usually found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself. The illustration below shows the location of the ALCL in these reports. In most cases, the ALCL cells were found in the fluid surrounding the implant (seroma) or contained within the fibrous scar capsule. [Modified from Thompson et al, 2010]

Q5. Does the surface texture of the breast implant shell–smooth versus textured–increase a woman's risk of developing BIA-ALCL?
A5. We have evaluated the growing body of evidence, including new medical device reports from the U.S. and around the world on the overall number of BIA-ALCL cases. These include additional deaths only recently reported to the FDA and in the scientific literature. As a result, we have determined that:

• All patients who have breast implants or are thinking about getting them should be aware of the risk of BIA-ALCL.
• The risk of BIA-ALCL is higher for textured surface implants versus smooth surface implants.
• Certain other textured breast products, specifically certain textured tissue expanders, should not be used, and we have issued new recommendations for patients who have or have had these products.

Q6. Could certain textured tissue expanders increase the risk of BIA-ALCL?
A6.  The FDA believes tissue expanders with a certain textured surface may be of concern. These tissue expanders should not be used and we have issued new recommendations for patients who have or have had these products. Tissue expanders are indicated to be used for only 6 months, and to date, there is limited information on whether temporary exposure may be associated with the risk of BIA-ALCL. Other tissue expanders that do not use the textured surface of concern are readily available in the U.S. A tissue expander is used stretch skin and other tissues before breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. It is a temporary implant, placed under the breast skin or muscles of the chest to stretch skin and other tissues, and is intended to be replaced with a breast implant at a later time.

Q7. Does the fill of the breast implant–silicone versus saline–increase an individual's risk of developing BIA-ALCL?
A7. Based on the currently available data, the type of implant fill does not appear to be a risk factor for BIA-ALCL, but this has not been evaluated in a large, well-designed, epidemiologic study. To date, there has not been sufficient data to determine whether ALCL may be found more or less frequently in individuals with silicone-filled breast implants compared to individuals with saline-filled breast implants.

Q8. What should health care professionals and patients do?
A8.The FDA is recommending that health care providers continue to provide their patients routine care and support.

Health Care Professionals:

• You should immediately stop using (implanting) the breast implants and tissue expanders listed in the July 24, 2019 FDA Safety Communication; and work with your facility to return existing inventory.
• We are not recommending the routine removal of these or other types of breast implants in patients who have no symptoms.
• You should inform your patients who have the implants and tissue expanders listed in the July 24, 2019 FDA Safety Communication about the risks of serious adverse health consequences, including the potential for the development of BIA-ALCL.
• Prior to implantation of any breast implant, provide your patients with the manufacturer's patient labeling, as well as any other educational material, and discuss the benefits and risks of the different types of implants.
• Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant changes. In some cases, patients presented with a seroma, mass, hardening adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer the patient's case to experts familiar with the diagnosis and treatment of BIA-ALCL.
• Collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and Anaplastic Lymphoma Kinase (ALK) markers.
• Develop an individualized treatment plan in coordination with experts familiar with the diagnosis and treatment of BIA-ALCL. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.

Patients:

• If you have no symptoms, we are not recommending the removal of the implants and tissue expanders listed in the July 24, 2019 FDA Safety Communication; or other types of breast implants due to concern related to the risk of developing BIA-ALCL.
• Know the symptoms of BIA-ALCL, primarily persistent swelling, presence of a mass or pain in the vicinity of the breast implant and monitor the area around your breast implants for any changes.
• If you experience any of these symptoms or other changes, talk to your healthcare provider regarding the need for further evaluation. Evaluation for BIA-ALCL typically involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. It is important to undergo an evaluation to diagnose BIA-ALCL since a confirmed BIA-ALCL diagnosis may change the type of operation that should be performed.
• Patients with confirmed BIA-ALCL should undergo implant removal with removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone.
• As with any implanted device, it is good to keep a record of the device manufacturer and implant model name. You may have received this information on a patient device card from your surgeon. If you would like to obtain the manufacturer name and model of your implants, consider asking your surgeon or obtaining the record of your surgery (operative notes) from the facility where it was performed.
• Understand that most cases of BIA-ALCL occur years after breast implant placement and present with symptoms or changes around the breast implant. Talk to your surgeon about your risk of developing BIA-ALCL.
• If you are considering breast implants, please see these important recommendations.

We will continue to report on significant findings as new information and analyses become available.

Women with breast implants should continue to have mammograms. (A woman who had an implant following a mastectomy should ask her doctor whether a mammogram of the reconstructed breast is necessary.)

Implants can hide some breast tissue, making it more difficult for the radiologist to detect an abnormality on the mammogram. It is important to let the mammography facility know about breast implants when scheduling a mammogram. The technologist and radiologist must be experienced in performing mammography on women who have breast implants. 

If the technologist performing the procedure is aware that a woman has breast implants, steps can be taken to make sure that as much breast tissue as possible can be seen on the mammogram. A special technique called implant displacement views may be used.

Should I get breast implants? Should they be saline or silicone? Which style? How much monitoring is needed after surgery? Those are common questions people have when considering breast implants.

The FDA has approved implants for increasing breast size (known as augmentation), for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. The FDA has also approved breast implants to correct or improve the result of a previous surgery.

There are two types of FDA-approved breast implants: saline-filled (saltwater solution) and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness, shell surface texture, and shape (contour).

Know the Risks of Breast Implants

FDA-approved implants undergo extensive testing before approval to demonstrate reasonable assurance of safety and effectiveness. Still, there are risks associated with all breast implants, including:

• Additional surgeries
• Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), which is a cancer of the immune system
• Systemic symptoms, commonly referred to as Breast Implant Illness (BII)
• Capsular contracture (scar tissue that squeezes the implant)
• Breast pain
• Rupture (tears or holes in the shell) of saline and silicone gel-filled implants
  • Deflation (with visible change to breast size) of saline-filled implants
  • Silent (without symptoms) rupture of silicone gel-filled implants
• Infection

The silicone used for breast implants is different than injectable silicone. Injectable silicone is not FDA-approved for breast augmentation, breast reconstruction, or for body contouring.

Breast Implants Are Not Lifetime Devices

The longer you have breast implants, the greater the chances are that you will develop complications, some of which will require more surgery.

The life of breast implants varies by person and cannot be predicted. That means everyone with breast implants may need additional surgeries, but no one can predict when. Patients can also request additional surgeries to modify the size or shape of their breasts.

Understand Product Labeling for Implants

To help patients be aware of the risks of breast implants before their surgery, the FDA requires that all FDA-approved breast implants include labeling with easy-to-understand information about the benefits and risks associated with the product. This requirement is intended to enhance the discussions patients have with their doctor about the benefits and risks of implants. The mandatory labeling information includes a patient decision checklist that highlights key information about risks; warning information formatted in a box to make it noticeable; and a patient device card with information specific to a patient’s implant, such as the serial or lot number and the style and size.

The FDA restricts the sale and distribution of breast implants to only health care providers and facilities that provide information to patients using the patient decision checklist. The patient must be given the opportunity to initial and sign the checklist before agreeing to surgery and it must be signed by the physician implanting the device.

Additionally, the FDA advises that patients read the Summary of Safety and Effectiveness Data and product labeling for each implant to learn about the materials used to construct the device, device characteristics and the fillers used. The Summary of Safety and Effectiveness Data have been produced for all approved saline and silicone gel-filled breast implants. The Summary of Safety and Effectiveness Data and the product labeling provide information on the indications for use, risks, warnings, precautions, and studies associated with the FDA’s approval of the device.

The Summary of Safety and Effectiveness Data also provides information on clinical study used for device approval. The most serious complications are those that lead to further surgeries, such as ruptures or capsular contracture, or BIA-ALCL diagnosis.

Communicate with Your Surgeon

Surgeons will discuss the shape, size, surface texture, placement of the implant, and the incision site for each person. Ask your surgeon questions about their experience in performing breast implant surgeries, the surgical procedure, and the ways the implant might affect your life.

Tell your surgeon about previous surgeries and your body’s response. For example, discuss whether surgeries resulted in a more than expected amount of scar tissue. Also, discuss your expectations. These discussions will help you and the surgeon make decisions that achieve the desired appearance, including decisions about incision location and size, as well as implant size, material, texture, and placement.

Many patients have additional operations to change implant size. To achieve the best results after the first procedure, careful planning and reasonable expectations are necessary.

Know the Long-Term Risks of Breast Implants

The FDA has identified an association between breast implants and the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma. Patients who have breast implants may have an increased risk of developing this cancer which mostly develops in the fluid or scar tissue surrounding the implant.

Breast implants have either smooth or textured surfaces (shells). BIA-ALCL develops more frequently in patients with textured implants than in those with smooth-surfaced implants. Like other lymphomas, BIA-ALCL is a cancer of the immune system and not of breast tissue.

Some patients with implants have also reported health problems such as connective tissue diseases (such as lupus and rheumatoid arthritis), trouble breastfeeding, or reproductive problems. There is currently insufficient evidence to support an association between breast implants and those diagnoses.

Additionally, some patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established.

Monitor Your Breast Implants

In general, follow your surgeon’s instructions on how to monitor your breast implants.

If you notice any unusual signs or symptoms, report them promptly to your surgeon or health care provider. Health care providers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Also, follow your health care provider’s instructions for imaging for screening for breast cancer as this may be different for those patients who had breast augmentation and for those patients who had breasts reconstruction. If you are making an appointment for mammography, inform the mammography facility that you have breast implants, and ask them what you can expect regarding mammography with breast implants.

Your surgeon or health care provider may also recommend other tests, such as ultrasound or magnetic resonance imaging (MRI). The FDA recommends that patients with silicone implants get regular screenings to detect silent ruptures.

If you have specific questions about breast implants, ask your surgeon or health care provider.