Contains Nonbinding Recommendations  
 
 
Breast Implants  - Certain  Labeling 
Recommendations to  Improve Patient 
Communication  
______________________________________________________________________________  
Guidance  for  Industry and  
Food and Drug Administration  Staff  
 
Document issued on September 29, 2020.  
 
The draft of this  document was issued on October 24, 2019.  
 
For questions about this  document, contact  OHT4: Office of  Surgical and Infection Control  
Devices/DHT4B: Division of Infection Control and  Plastic  Surgery Devices at  301-796-6970.  
 
The  recommendations in this  guidance  supplement the  recommendations in 
FDAs Guidance  Saline, Silicone Gel, and Alternative  Breast Implants  
guidance, issued September 29, 2020.  
 
 
 
U.S.Department of Health and Human Services  
Food and Drug Administration  
Center for  Devices and Radiological Health  
 
  
 
 
  Contains Nonbinding Recommendations  
 
 
Preface  
 
Public Comment  
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD  20852. 
Identify all comments with the docket number  FDA-2019-D-4467. Comments may not be acted  
upon by the  Agency until the document is next revised or updated.  
 
Additional Copies  
 
Additional copies are available from  the Internet. You may also send an e-mail request to  
CDRH-Guidance@fda.hhs.gov  to receive a  copy of the guidance. Please  use the document  
number  19021  and complete  title of  the guidance in the  request.  
 
  Contains Nonbinding Recommendations  
 
 
Table of Contents 
 
 
I.       Introduction  ..........................................................................................................................  1  
II.   Background ..........................................................................................................................  1  
III.   Scope ....................................................................................................................................  3  
IV.   Labeling Components  ..........................................................................................................  4  
  Boxed Warning  ................................................................................................................  4  
  Patient Decision Checklist  ...............................................................................................  5  
V.   Additional Labeling Recommendations  ..............................................................................  6  
  Rupture Screening Recommendations Update .................................................................  6  
  Materials/Device Descriptions  .........................................................................................  7  
  Patient Device Card ..........................................................................................................  7  
Appendix A: Boxed Warning Example  ..........................................................................................  9  
Appendix B: Patient Decision Checklist Example  .......................................................................  10  
Appendix C: Materials  Device Description Example ...................................................................  17  
 
 
  Contains Nonbinding Recommendations  
 
 
Breast Implants  - Certain  Labeling 
Recommendations to  Improve Patient 
Communication  
______________________________________________________________________________  
Guidance  for  Industry and  
Food and Drug Administration  Staff  
 
This guidance  represents  the  current thinking of the  Food and Drug Administration  (FDA  or  
Agency)  on this topic. It  does not  establish  any rights  for any person and is not  binding on  
FDA or the  public. You can  use an alternative  approach if  it  satisfies the requirements of the 
applicable statutes and regulations. To discuss  an alternative approach, contact  the FDA staff 
or Office responsible for this guidance  as  listed on the title  page.   
 
I.   Introduction  
This guidance contains recommendations concerning the  content and format  for  certain labeling  
information for  saline and silicone gel-filled  breast implants.  FDA is  issuing this guidance  to 
help ensure that a patient  receives and understands  the benefits and risks  of  these devices.  The  
recommendations are being made based on concerns  that  some patients  are not  receiving  and/or  
understanding information regarding the  benefits and  risks of  breast implants.  These labeling 
recommendations are intended  to  enhance,  but not replace,  the physician-patient discussion of  
the benefits  and risks  of breast implants  that uniquely pertain to individual  patients.  
 
FDA's guidance documents, including this guidance, do not establish legally enforceable  
responsibilities. Instead, guidances describe the  Agencys current  thinking on a topic  and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are  
cited. The use of the word should  in Agency guidance means that something is suggested or  
recommended, but not  required.  
 
II.   Background  
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.  The use of breast implants in reconstructive  and augmentation procedures is  
elective,  and alternatives to the use of breast  implants exist  (such as an external breast prosthesis  
and tissue reconstruction).   
1   Contains Nonbinding Recommendations  
 
 
There are two types of breast  implants approved for sale in the United States: saline-filled and 
silicone gel-filled.  Saline-filled breast implants are  inflated to the  desired  size  with sterile  
isotonic saline. Silicone gel-filled  breast implants  contain a fixed volume of silicone  gel. Silicone  
gel viscosity differs among implants and manufacturers.      
 
Breast  implants are manufactured with smooth and textured surfaces.  The outer surface, or  
shell  for both types of  breast  implants is manufactured from polysiloxane silicone  rubber and 
may vary in shell surface, shape, profile, volume, and thickness.  For breast implants with a  
textured shell surface, each breast implant manufacturer  utilizes a proprietary manufacturing 
process to create the textured surface, which means that  each  manufacturers textured shell is 
different.   
 
Over the past few years,  FDA  has received  new information pertaining to risks associated with 
breast implants,  including breast implant-associated anaplastic large cell lymphoma (BIA-
ALCL)  and systemic symptoms commonly referred  to as breast implant illness  (BII) that some 
patients  attribute  to their implants. BIA-ALCL  is  a type of non-Hodgkins 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 individuals  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, but some patients may require  chemotherapy 
and radiation therapy.  The most common  symptoms of BIA-ALCL are persistent swelling, 
presence of a  mass  or pain in the area of the breast implant that may occur years  after implant 
placement.  Systemic symptoms such as fatigue,  memory loss, rash, brain fog, and joint pain 
have been reported by some patients with breast implants. The term breast implant illness has 
been used to describe these symptoms.  Researchers are investigating these symptoms to  better  
understand their  origins. The  exact  relationship of these symptoms with breast implants is  
unclear  at this  time.   
 
FDA has taken a number of steps to better understand and address risks  associated with breast  
implants,1  including convening  the General and  Plastic Surgery Devices Advisory Panel  
(Panel)  on March 25-26, 2019,  to discuss  the long-term benefits and risks of breast  implants 
indicated for  breast  augmentation and reconstruction.2  The meeting covered a range of important  
topics on breast  implant safety, including characterization of BIA-ALCL  incidence and risk  
factors, and  methods for  assessing systemic symptoms. The Panel gave recommendations on  
these  topics, including recommending that FDA  require  a boxed warning in  breast implant 
labeling  and a standardized checklist  as part of the informed consent process, revise  the  MRI  
screening recommendations  for silent ruptures of silicone gel-filled breast implants, and provide  
greater transparency  regarding materials present in breast  implants; the  Panel also discussed the 
role of the patient device card in providing important information about the patients breast 
implant.3  In addition, FDA learned from presentations at the  March 2019 Panel meeting and 
                                                 
1  For  more information,  see https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants.   
2  For  more information  and  meeting  materials, see https://www.fda.gov/advisory-committees/advisory-committee-
calendar/march-25-26-2019-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee.   
3  Ibid.   
 
2   Contains Nonbinding Recommendations  
 
 
through comments submitted to the associated public docket,4  that  some patients may not be  
receiving or understanding important information regarding  the  benefits and risks of breast  
implants  in  a format that allows them to make a well-informed decision about whether  or not to 
have a breast implantation.  Notably, approved labeling for  currently marketed  breast implants is 
lengthy, often  in excess of fifty pages.5   
 
For these  reasons, FDA is now providing recommendations concerning the content and format  of  
certain labeling information for these devices. Specifically, FDA is recommending that  
manufacturers incorporate a boxed warning and a patient decision checklist into the  labeling for  
these devices to  better ensure certain information is received and understood by patients. This  
guidance also recommends updated and additional labeling information, including updates  to the  
silicone gel-filled  breast implant rupture screening recommendations, inclusion of an easy-to-
find description of  materials, and provision of patient device cards  that were recommended at the 
March 2019 Panel meeting.   
 
The  Agency will  continue  to monitor information about potential safety risks  and take steps to 
ensure they are being adequately conveyed to and understood by physicians  and patients.  
 
III.   Scope  
This guidance  provides  recommendations  concerning the  content and format of  certain  labeling 
information  for breast implants filled  with saline or silicone gel  indicated  for breast 
augmentation or breast reconstruction.   
 
FDA believes it is important for patients considering breast implants to have the  information they  
need for  a balanced discussion with their physicians  regarding the benefits  and risks of breast  
implants. To  help  ensure  that patients  have this information,  a boxed warning,  a patient decision 
checklist, and a patient  information  booklet/brochure  specific to the breast implant  should be  
provided by manufacturers and given to patients prior to  implantation. For those patients who 
decide to have breast implants,  a patient device card  should  also  be provided to patients after  
surgery. FDA intends to work with manufacturers of new  breast  implants  through the  premarket  
approval  application  (PMA) process, and manufacturers of currently  marketed breast implants  
through the  PMA supplement process, to integrate these  important labeling  recommendations.   
 
This guidance is not intended to include a complete listing of  all labeling components  for  breast  
implants. This  guidance  should be used as a complement to FDAs Guidance on Medical  
Device Patient Labeling6  (which describes FDAs current thinking on making medical device  
patient labeling understandable to and usable by patients), existing regulations, and other  
relevant guidance documents containing additional labeling recommendations.   
 
                                                 
4  FDA-2019-N-0426.  
5  In some cases,  the  labeling  exceeds  100  pages.  Links  to patient  labeling at  the  time  FDA  approved the  implant  are  
available here:  https://www.fda.gov/medical-devices/breast-implants/labeling-approved-breast-implants.   
6  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-
labeling.  
 
3   Contains Nonbinding Recommendations  
 
 
This guidance  also  supplements FDAs Guidance Saline, Silicone Gel, and Alternative Breast 
Implants7  (hereafter referred to  as the Breast Implant Guidance)  and should not  be construed 
as a replacement for  such  guidance.  Manufacturers should consider  both the  recommendations  in 
this  guidance  and  in the  Breast Implant Guidance.  
 
We note that accurate product labeling and effective communication of that labeling  are 
important to  help ensure that patients are aware of the risks associated with breast  implants prior  
to undergoing implantation. Moreover, a device  shall  be deemed misbranded if, among other  
things: its labeling  is false or misleading; its labeling  does not contain adequate warnings;  or any 
information required to be in the  labeling is not prominently placed with such conspicuousness  
and in such terms to render it likely to be read and understood by the  ordinary  individual under  
customary conditions  of purchase  and use (see  sections 502(a), 201(n), 502(c), and 502(f)(2) of  
the Federal  Food, Drug, and Cosmetic Act (FD&C Act)).8   
 
IV.   Labeling Components   
The patient booklet/brochure and the patient device card  are all part of the patient labeling  for  
breast implants. FDA recommends that the patient booklet/brochure  include a boxed warning, 
patient decision checklist, rupture  screening recommendations, and materials/device description  
(as described in this guidance) as well as other  patient information (as described in  the Breast  
Implant Guidance).  
 
Specifically,  FDA believes  manufacturers should include  a  boxed warning and patient decision 
checklist  to  help ensure patients receive and  understand  information about the  benefits and  risks 
of breast implants. This section contains FDAs format and content  recommendations for these 
components,  and to  help illustrate, FDA has provided  examples of each  in the appendices.  
 
  Boxed Warning  
FDA believes that a boxed warning should be part of physician and patient labeling materials for  
breast implants. In general, boxed warnings are  noticeable and easy to  read and understand, and 
FDA believes a boxed warning would be particularly useful in communicating risks that have  
been identified in new information  and for which patients  may  be  unaware. To achieve the goals  
described above, FDA recommends that a boxed warning  generally  inform patients  that:  
 
   Breast  implants are not considered  lifetime devices;   
   The chance  of developing complications  increases  over time;   
   Some complications will require more surgery;  
   Breast  implants have been associated  with the development of  a cancer of the immune 
system called breast  implant-associated anaplastic large cell lymphoma (BIA-ALCL);  
                                                 
7  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-
breast-implants.  
8  Under  section  301(a)  of  the  FD&C Act,  it  is  a  prohibited  act  to  introduce  or  deliver  for  introduction  into  interstate  
commerce any  device that  is  misbranded.  
4   Contains Nonbinding Recommendations  
 
 
   BIA-ALCL  occurs more commonly in patients with textured breast  implants than smooth 
implants, and  deaths have occurred  from BIA-ALCL;  and  
   Breast implants have  been  associated with  systemic symptoms.   
 
FDA believes that this form and content of boxed warning will help to ensure that  patients  
receive  and understand information regarding the  benefits and  risks of these  devices.  An example  
of a boxed warning that follows these  recommendations  is provided in Appendix A.    
 
  Patient Decision  Checklist  
FDA also believes that a  patient decision checklist highlighting key information  regarding risks  
should be included at the end of the patient  information booklet/brochure.   
 
To  help ensure the  checklist  is read and understood by patients, FDA  is providing 
recommendations regarding content  and organization below. First, FDA recommends that  the  
introduction for the checklist  include a description of the purpose and importance of the  
checklist, as well as  instructions  to patients  on how to review  and complete the document prior to 
deciding  whether  to undergo the  implant procedure.  Next, to achieve the goals  described above, 
FDA recommends that the body of the checklist  include  the following:  
 
   Situations in which the device should not be used or implanted;   
   Considerations for a successful breast implant candidate;  
   Risks of undergoing breast implant surgery;  
   Importance of appropriate  physician  education, training and experience;  
   Risk of  BIA-ALCL;   
   Risk of  systemic symptoms; and  
   Discussion of  options  other than breast implants, as appropriate.  
 
Additionally, to help ensure the material is  reviewed, FDA recommends  the checklist allow for 
patients and  physicians to affirmatively acknowledge (e.g., via initials and/or signatures) that 
specific information was read and discussed.   
 
FDA recommends that a copy of the patient decision checklist be provided to the patient  so that  
the patient can refer back to this  important information. The  FDA also encourages device 
manufacturers to develop a plan to ensure that patients are adequately informed of the risks of  
breast implants and breast implant surgery,  to update the checklist as additional data  are  
collected with post-market experience, and to provide a dedicated website link for each device  
that allows  providers  involved in the  care of breast implant patients  and patients with that  
specific breast implant to regularly monitor changes to the patient decision  checklist, boxed  
warning, and product label.  FDA specifically recommends that the rates of  BIA-ALCL  included  
in the patient decision checklist reflect current  information based on  estimated incidence rates.  
These rates include overall  incidence rates of BIA-ALCL,  as well  as rates  for  the manufacturers 
specific breast implant based on published literature, registries, and medical device reports.  
Manufacturers should explain in the  patient decision checklist the methodology used for  
determining  the incidence rates for BIA-ALCL.   
5   Contains Nonbinding Recommendations  
 
 
An example of a checklist that follows these  recommendations is provided in Appendix B.  
Please note the  rates  for risks  provided in this example checklist  are derived from percentages of  
reported complications  for approved breast  implants  in publicly available  summaries of safety  
and effectiveness data (SSEDs)  at the time of  issuance of  this guidance document. These  
numbers are provided for illustrative  purposes only. FDA recommends that manufacturers  
patient decision checklists identify the percentages of reported complications for their specific  
implants based on current information.  
 
V.   Additional Labeling Recommendations  
This section contains additional labeling recommendations  for  the physician and patient labeling 
of breast implants. Specifically, this section  includes recommendations  on rupture  screening for  
silicone gel-filled  breast implants,  a materials/device description in the product labeling of  breast  
implants filled with saline or silicone gel indicated  for breast  augmentation or breast  
reconstruction,  and a patient device card.   
 
The updated rupture  screening recommendations follow the  consensus  recommendation of the  
Panel to  remove the current FDA MRI screening recommendations,  and to adopt screening  
recommendations  that begin between years 5 and 6 post surgery, and occur  every 2-3 years after  
that.9  Additionally, FDA is also recommending ultrasound as an acceptable alternative for  
screening asymptomatic patients pursuant to  the Panels recommendation.  These  additional  
labeling recommendations  were discussed at  the March 2019  Panel Meeting.10  
 
  Rupture Screening Recommendations  Update   
We recommend  that  the  physician and patient labeling for silicone gel-filled breast implants11  
include  the specific, updated rupture  screening recommendations  as shown below:  
 
Physician Labeling:   
For asymptomatic patients,  the first ultrasound or  magnetic resonance imaging (MRI)  should be  
performed at 5-6 years postoperatively, then every 2-3  years thereafter.   
 
For symptomatic patients or patients with equivocal ultrasound results  for rupture at any time  
postoperatively, an  MRI  is recommended.    
 
Patient Labeling:   
It is  recommended that you have periodic  imaging (e.g., MRI, ultrasound)  of  your  silicone gel-
filled  breast implants to screen for implant rupture regardless  of  whether  your implants  are for  
cosmetic augmentation  or reconstruction. These recommendations do not replace other  
additional  imaging that may be required depending on your medical history or circumstances  
(i.e.,  screening  mammography for breast cancer).    
                                                 
9  24-hour  Panel  meeting  summary  available at  https://www.fda.gov/media/122960/download.  
10  For  more information  and  meeting  materials, see https://www.fda.gov/advisory-committees/advisory-committee-
calendar/march-25-26-2019-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee.  
11  Saline-filled  breast  implants  do  not  have  screening  recommendations  as  rupture is  detectable without  screening.  
6   Contains Nonbinding Recommendations  
 
 
Even if  you have no symptoms, you should have  your first ultrasound or  MRI at 5-6 years after  
your initial implant surgery and then every 2-3  years thereafter.   If you have symptoms at any 
time or uncertain ultrasound results  for breast implant rupture, an  MRI is  recommended.     
 
  Materials/Device Descriptions    
At the March 2019 Panel meeting,12  patients and panel members expressed concern about not  
knowing the  materials used in  breast  implants and the possible deleterious health  effects of these 
materials. They emphasized the importance of greater communication and transparency  
regarding the materials present in breast implants  to help  patients to make  an informed decision  
about  implantation in light of  potential adverse effects due to these materials, including in the  
event of rupture, leakage,  or diffusion. Therefore, in addition to the  labeling  recommendations 
provided in the  Breast Implant Guidance,  FDA recommends the patient  information 
booklet/brochure  also  include a detailed device description of the materials  of construction of the  
breast  implant shell and  filling  in a format that is understandable to  the  patient.   
 
Specifically,  FDA recommends that  the  patient information booklet/brochure  include tables  
listing breast implant materials, chemicals that  might  be released from breast implants,  and 
heavy metals present in  breast  implants.  FDA recommends that the patient information 
booklet/brochure provide context  to the levels of risk/exposure of the chemicals and heavy 
metals  listed  in these  tables.  For example, manufacturers may note that the  potential toxicity of  
the chemicals and metals have been evaluated through toxicity testing and risk assessments to  
assess  the exposure levels in comparison to the  amount determined to likely be safe, but that  
individual responses may vary, and that all reactions cannot be predicted.  Appendix C  provides  
an example of a format that  follows these recommendations. Please note the  concentrations  
included in the  Materials Device Description  Example  in Appendix C  are provided for  
illustrative purposes only.  
 
Although this information is currently publicly available in the FDA Summary of Safety and 
Effectiveness Data (SSED)  for each of the approved breast implants,13  FDA recommends  that  
this detailed device description  information be available and  easily accessible to  the  patients to 
help ensure  transparency  and patient safety. This device description  information is intended to 
help inform  the patients  of the  types and quantities of  chemicals  and heavy  metals that are 
detected  in breast implants. The patient should also be informed that most of these chemicals  
stay inside  the shell of the implant but small quantities have  been found to diffuse (gel  bleed)  
through the implant shell  of  silicone gel-filled implants,  even if  the implant is intact and not 
ruptured or leaking.   
 
  Patient Device  Card   
Breast  implants are subject to medical device tracking requirements under section 519(e) of the 
FD&C Act; tracking is  intended to facilitate notification and  recall in  the  event a device presents 
                                                 
12  For  more information  and  meeting  materials, see https://www.fda.gov/advisory-committees/advisory-committee-
calendar/march-25-26-2019-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee.  
13  See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.   
7   Contains Nonbinding Recommendations  
 
 
a serious risk to health that requires  prompt attention. As such, we believe it is important to  
include  specific information related to the device  in the patient device card.  
 
This piece of labeling has been referred to in different ways by  manufacturers, such as  a 
manufacturer device card, patient identification  card, or patient information card. Regardless of  
the name used, the purpose of the patient device  card is  to provide patients  with specific 
information about  their device(s).  As such, FDA recommends that  the card clearly be labeled so  
that  the physician can easily find it and provide  it  to the patient  immediately following surgery.  
 
Additionally, we recommend  that  the device card  include, but need not  be limited to,  the  
following information:  
 
   A statement that  This card belongs  to the patient. Please give it to the patient.   
   Devices serial or lot number;  
   Devices style and size;  
   Unique  Device Identifier  (UDI);14   
   Web link to  access most current patient  decision checklist, boxed  warning, and labeling  
for the specific implant that the patient received;  
   A statement that There is a boxed warning for breast  implants, see web  link;  and  
   Toll-free phone number  to the  breast implant  manufacturer.  
 
 
   
                                                 
14  For  additional  details  on the  requirements  for the  unique  device  identifier,  see  FDAs  Unique  Device  
Identification  System  final  rule  (78  FR  58785  (Sep.  2013)).  
8   Contains Nonbinding Recommendations  
 
 
Appendix  A: Boxed Warning Example  
WARNING:   
   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.  
   Breast implants have been associated with the development of a 
cancer of  the immune system called breast implant-associated  
anaplastic  large cell lymphoma (BIA-ALCL).  This cancer occurs 
more commonly in patients with textured breast implants  than  
smooth implants, although rates are not well defined. Some patients 
have died from BIA-ALCL.  
   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.  Some 
patients report complete resolution of symptoms when the implants 
are removed  without replacement.  
   
9   Contains Nonbinding Recommendations  
 
 
Appendix B: Patient Decision Checklist Example  
 
To the patient considering breast  implants filled  with saline or silicone gel intended for breast 
augmentation or breast reconstruction:  
 
The review  and understanding of this document is a critical step in making the decision whether  
you should choose breast implant surgery. You should learn about breast  implants and then 
carefully  consider  the benefits and risks associated with breast implants  and breast implant  
surgery before you make that decision. This form lists important risks, including those known or  
reported to be associated with the use  of the device based on information from clinical  trials, 
scientific literature, and  reports from  patients who have undergone device placement.  
 
This patient  decision checklist is  intended to supplement the additional patient  labeling that  
should be provided to you by your  physician. You should receive  a patient  booklet/brochure that  
includes important information about your specific breast  implant, as  well as a boxed warning 
and patient  decision checklist. After reviewing  the information in the  patient information 
booklet/brochure  for the specific implant  that will be used, please read and discuss the items in  
this 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. Your  
full signature at the end  of this document  means that you have read  the materials  and  that your  
physician  has answered all questions  to your satisfaction.  
 
Considerations  for  a  Candidate for  Successful  Breast  Implantation  
 
I understand that  I am not a candidate for breast  implants if any of the following situations  
applies to me:  
 
   I have an active infection anywhere in my body;  
   I have an existing cancer or pre-cancer of  my breast tissue that has not been adequately  
treated; or  
   I am pregnant or nursing.  
 
I understand that  if I have any of the  following conditions, I may be at a higher risk for a poor  
surgical outcome:  
 
   Medical condition that  affects my bodys ability to heal (e.g., diabetes, connective tissue 
disorder);   
   Active smoker or a former smoker;   
   Currently taking drugs that weaken the bodys natural resistance to disease,  such as 
steroids and chemotherapy drugs (e.g., prednisone, tacrolimus, sirolimus, mycophenolate, 
azathioprine, cyclosporine, methotrexate, chlorambucil, leflunomide, or  
cyclophosphamide);   
   History of chemotherapy or planned chemotherapy following breast  implant placement;   
   History of radiation therapy or  planned radiation following breast implant  placement;   
10   Contains Nonbinding Recommendations  
 
 
   Conditions  that interfere  with wound healing or blood clotting  (e.g., hemophilia, von 
Willebrand disease, factor V  Leiden, hyperhomocysteinemia, protein C  deficiency, anti-
thrombin III deficiency, or systemic lupus erythematosus);  or  
   Reduced blood supply to the breast  tissue.  
 
I understand the following conditions have not been adequately studied   to determine whether the  
conditions put me at higher risk:  
 
   Autoimmune disease (e.g.,  Hashimotos, Lupus, Rheumatoid Arthritis)  or family history  
of autoimmune disease  (breast implant premarket clinical studies have not evaluated  the 
safety of breast implants in patients with autoimmune disease);  
   Clinical diagnosis of depression or  other mental health disorder (including body 
dysmorphic disorder or eating disorder); or  
   Have other  products  permanently  implanted  in the breast.  
 
Patient Initials: __________  
 
Risks of Breast Implant Surgery   
 
I understand that there  are risks15  of undergoing breast implant surgery. I understand  that risks of  
undergoing breast  implant surgery may include:   
 
   breast pain (reported in up to 36.5% of procedures),  
   skin or nipple areola sensitivity changes or loss (reported in up to 35% of procedures),  
   asymmetry (reported in up to 28% of procedures),   
   impact of aging or weight change on size and shape of breast  (reported in up to 10% of  
procedures),   
   infection requiring possible removal of implant (reported in up to 9% of procedures),  
   swelling (reported in up to 9% of procedures),  
   scarring (reported in up to 7% of procedures),  
   fluid collections (seroma) (reported in up to 6.5% of procedures),  
   hematoma (reported in up to 2.8% of procedures),  
   tissue death of breast skin or nipple (reported in up to 2% of procedures),  
   inability to breast feed (reported in up to 1.6% of procedures),  
   complications  of anesthesia (reported in up to 1% of procedures),   
   bleeding  (may occur but specific rates  are not publicly available in Summaries of Safety  
and Effectiveness Data (SSEDs)16),  
   chronic pain  (may occur but specific rates are not publicly available in SSEDs),   
   damage to  surrounding  tissue, such  as muscle, nerves, and blood vessels  (may occur  but  
specific  rates are not publicly available in SSEDs),  and   
                                                 
15  These  rates  were  reported  in  the  clinical  studies  used  to  support  approval  of  breast  implants  up  through  October 
2019.  Each  rate specified  herein  represents  the largest  percentage reported  in  any  PMA  approved  for  breast  implants  
up through October  2019.  
16  See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.  
11   Contains Nonbinding Recommendations  
 
 
   impact on imaging of breast  tissue  (may occur but specific rates are not  publicly available  
in SSEDs).  
 
My physician  has discussed these risks and has provided me with the patient information 
booklet/brochure  (including  the boxed warning)  with  information  on the types of  risks that are 
possible and expected  rates of occurrence.   
 
My physician has discussed the potential  use of other  implanted products during my breast  
implant surgery.  My physician has also discussed the risks and benefits of using these implanted  
products and their planned surgical approach.  
 
Patient Initials: __________  
 
Risk of Cancer - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-
ALCL)   
 
I understand that breast implants are associated with the development of a type of cancer of the 
immune system called Breast Implant-Associated  Anaplastic Large Cell Lymphoma (BIA-
ALCL).  Information regarding the number of  medical device  reports of BIA-ALCL can be found 
on FDAs website.17  I have received information regarding  the  overall incidence rates of BIA-
ALCL and the rates as they pertain to  my specific breast implant.  
 
I understand that this cancer has been reported more frequently for textured breast  implants, but  
that patients  with smooth surfaced implants have  also been diagnosed.  
 
I understand that patients with breast  implants have a risk of  developing BIA-ALCL  within  the  
scar tissue and fluid surrounding the breast implant.  
 
I understand that BIA-ALCL typically takes several years  to develop after implantation, but  
cases have been reported as early as within one year. Typical  symptoms to be aware of include:  
swelling, breast  tightness, pain, lumps, or swelling of  the  breast months or years after  I receive 
my implants.  
 
I understand that treatment for BIA-ALCL involves an operation to remove the implants and the  
surrounding scar  tissue capsule. Based on the stage of the cancer at diagnosis, some patients have 
required chemotherapy or radiation. While BIA- ALCL typically responds well to therapy, some  
patients have died from  BIA-ALCL. Diagnosis and treatment  may be at  my own expense and is  
not always covered by insurance.  
 
Patient Initials: __________  
 
 
 
                                                 
17  See Medical  Device Reports  of  Breast  Implant-Associated  Anaplastic Large  Cell  Lymphoma, available at  
https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-
large-cell-lymphoma.  
12   Contains Nonbinding Recommendations  
 
 
Systemic Symptoms   
 
I understand that some  patients who  have received breast  implants have reported a variety of  
systemic symptoms including joint pain, fatigue, rash, memory loss, and brain fog  that some 
patients have called breast implant  illness. While the causes of these symptoms are unclear, some 
patients have reported relief of these  symptoms  with removal of their implants  and surrounding 
scar  tissue capsule, however not  all  patients may experience improvement in their symptoms. 
Researchers are working  to better understand  the possible link  between breast implants and these 
symptoms.  
 
I also understand that some patients  with breast implants have reported health problems in their 
children after birth or breastfeeding.  While a causal link between breast implants and  these 
reported  health problems in children  has not been demonstrated, more research  is  needed. I 
understand  that breast  implants and  breast  surgery may interfere with my ability to  successfully  
breastfeed.   
 
Patient Initials: __________  
 
Breast-Implant Specific Risks  
 
I understand that a breast implant is  NOT a lifetime device and the longer I have my implants, 
the more likely I am to experience a  complication and the more likely  I am to require a  
reoperation requiring the replacement or removal of  my breast implant.  As many as 20 percent of  
women who receive breast implants  for augmentation have  to have their implants removed 
within 8 to 10 years, but  my implants  may last for a shorter or  longer time.   
 
I understand that my breast implant  may rupture or  leak  at any time,  and  that the  longer I have  
my implants, the more likely I am to experience a complication such as rupture. I understand that  
gel  bleed (small quantities of chemicals diffusing  from the implant shell)  of silicone  gel-filled  
implants  may occur. I understand that if I have a  saline-filled  implant,  my  breast may deflate in  
appearance if there is a rupture or  leakage of the saline.   
 
I understand that  if I have a silicone gel-filled breast implant, I or the  physician may not be able  
to tell on physical exam  whether my implant has ruptured or is leaking silicone gel. Because 
rupture or leakage  of silicone  gel-filled breast implants  is difficult to detect, I understand that 
periodic imaging evaluation is recommended for screening of silicone gel-filled breast implant 
rupture. It is  recommended that  I have periodic imaging of  my  silicone gel-filled breast implants  
to screen for implant rupture regardless of whether my implants are for  cosmetic augmentation or  
reconstruction. These recommendations do not replace other  additional  imaging that may be  
required depending on my medical history or  circumstances (i.e.,  screening mammography for  
breast cancer).    
 
Even if I have no symptoms, I should have regular imaging evaluations as described in the  
Recommended Follow-Up  section below. These imaging evaluations  may not detect all  
ruptures or leaks, be costly, and the  expense may not be covered by my medical insurance.  
 
13   Contains Nonbinding Recommendations  
 
 
I understand that silicone can migrate from  my implant  into nearby tissues  (e.g., chest wall, 
lymph nodes under the  arm) and organs (e.g., liver, lungs) where it may not be possible to 
remove.  
 
I understand that all breast implants can interfere  with mammography and breast exams, which  
could delay the diagnosis of breast cancer. Mammography can also cause the breast  implant to 
rupture or leak. I should tell the mammography technician if I  have breast implants.  
 
I understand that  the long-term  risks of  breast implants  may include:  
   painful or tightening of  scar tissue  (capsule)  around my implant (capsular contracture)  
(reported in up to 51.7% of  patients),  
   rupture or leaking of  the  implant  (reported in up to 31.2% of patients),  
   wrinkling of the implant  (reported in up to 20% of patients),  
   visibility of the implant  edges  (reported in up to 6% of patients),  
   shifting of the implant  (reported in up to 11.5% of patients), or   
   need for reoperation  (reported in up to 59.7% of patients).   
 
I understand that I will receive  a patient device card after my surgery that has information on 
each of my specific implants. I understand that it  is important  for  me to keep each card in case I  
or my physician need to know what kind of implant I have many years  later.  
 
I understand that all breast implants contain chemicals and heavy metals.  I understand that most  
of these chemicals stay inside the shell of the implant, but small quantities have been found to  
diffuse (gel  bleed)  through the implant shell  of silicone  gel-filled implants, even if the implant is  
intact and not ruptured or leaking.  A  list of the components, chemicals, and heavy metals is 
available in the  patient information booklet/brochure.  
 
Patient Initials: __________  
 
Recommended Follow-up  
 
Even if I have no symptoms, I should have my first ultrasound or MRI at 5-6 years after my  
initial  implant surgery and then every 2-3  years  thereafter.  If I have symptoms or uncertain 
ultrasound results for breast  implant rupture  at any time, an MRI is recommended.     
 
I understand that I will need  routine  and regular follow-up with my physician as  long as I have  a  
breast  implant for examination of my breast  implant as well as to discuss any updates regarding  
breast implant  issues.   
 
National Breast Implant Registry  (NBIR): I understand  and have discussed with my physician  
that there is a National Breast  Implant  Registry where information regarding my health and 
breast implant information can be entered.  The NBIR  may  help understand the  long-term  safety  
and performance of breast implants.  
 
Patient Registry and Outcomes For breast  Implants and anaplastic large cell Lymphoma (ALCL)  
etiology and Epidemiology  (PROFILE):  I understand and have discussed with my physician that 
14   Contains Nonbinding Recommendations  
 
 
there is  a registry  (PROFILE)  where information is collected to better understand  BIA-ALCL in  
patients with breast implants.  
 
Patient Initials: __________  
 
Questions for My Physician  
 
I have had the opportunity to ask my physician questions  about his or  her  experience, medical  
degree, specialty of training, and credentials. I  understand that  breast implants have associated  
procedural risks and should only  be used by physicians  who are appropriately trained.   
 
Patient Initials:  __________  
 
Options Following Mastectomy   
 
I understand that breast reconstruction is an elective procedure which I can choose to do or not.  
  
I understand that  I may choose not to have breast  reconstruction (going flat) and may choose to 
use an external prosthesis in my bra to look like I  have a breast when wearing clothes.  
 
I understand  the surgical options for  breast  reconstruction, including the  use of a breast implant  
and the use  of  my own tissue (autologous reconstruction).  
 
I understand that if  my breast implants are ever removed,  I  may be left with dimpling, chest wall  
concavity, puckering, or  sagging of my breasts or skin.  
 
I understand that more surgeries may be necessary in the future  due to complications or to 
remove or replace the breast implants.  
 
I have discussed  all of the options for breast  reconstruction with my provider, including  whether  
I am a candidate and  the benefits and  risks of each, and  I believe that breast reconstruction with a  
breast  implant is the best option for  me.  
 
Patient Initials:  __________  
 
Breast Augmentation Options   
 
I understand that breast augmentation is an elective procedure to increase the size of my breasts.   
 
I understand that breast augmentation  may result  in permanent changes to my breast tissue and if  
my implants are ever removed,  I may be left with  unsatisfactory appearance,  changes to the  size 
and shape of  my breasts,  including but not limited to  dimpling, chest-wall concavity, puckering, 
sagging, or  different incision size  or location.  
 
If I am an augmentation patient, any additional surgeries or  medical procedures will  likely be at  
my own expense.  
15   Contains Nonbinding Recommendations  
 
 
 
Patient Initials: __________  
 
 
CONFIRMATION OF DISCUSSION OF RISKS   
 
Patient: I acknowledge that I have received and read the  patient information booklet/brochure  
for the specific implant that will be used during my surgery and that  I have had time to discuss  
the  information  in it and on this document with my physician. I have had the opportunity to ask 
questions and understand the benefits and risks of breast implants for me,  given my specific 
health conditions. I have considered alternatives  to breast implants, including  reconstruction 
without breast implants,  no reconstruction/augmentation, and their  benefits and risks.   
 
 
_______________________________________  
Patient Signature  and Date  
 
 
 
Physician:  I acknowledge that  I have discussed  the benefits and risks of breast  implants as 
described  elsewhere in the  patient  information booklet/brochure  and in  this checklist. I have also 
explained the benefits and risks of  the alternatives. I have encouraged the  patient to ask 
questions, and I have addressed all questions.  
 
 
________________________________________  
Physician  Signature and Date  
 
16   Contains Nonbinding Recommendations  
 
 
Appendix C:  Materials Device Description Example  
 
The potential toxicity of  the chemicals and metals listed in the  following  tables have been  
evaluated with both toxicity testing and risk assessments to assess the exposure levels in  
comparison to the amount determined to likely be  safe. However, individual responses to 
chemicals may vary, and all  reactions cannot be predicted.  
 
1.   Breast Implant Device Materials  
 
Device Materials   Implant Component  
Dimethyl Silicone Elastomer Dispersion   Shell  
Diphenyl Silicone Elastomer Dispersion   Shell  
MED 4750 Silicone Elastomer   Shell  
Silicone Gel    Gel fill  
Platinum catalyst   Shell and fill  
 
2.   Chemicals Released by Breast Implants  
   
Volatiles: Chemicals that are released by breast  implants as a gas.  
Extractables: Chemicals that  are released by breast implants  following soaking in water  
and/or organic solvent  (liquid).  
Volatiles   Extractables  
Whole  Device  
Compound   Compound   Whole Device  (ppm)  
(ppm*)  
D  Siloxane    0.18   D  Siloxane   0.5  
3  3 
D  Siloxane   0.46   D Siloxane   <2.5  
4  4 
D  Siloxane   1.47   D Siloxane   <4.8  
5  5 
Methoxytrimethylsilane   0.43   D Siloxane   <8.4  
6 
Dimethoxydimethylsilane   0.03   D Siloxane   <8.4  
7 
Methoxytriethoxysilane   ND   D Siloxane   <8.3  
8 
Tetramethyldiethyldisiloxane   0.04   D9  Siloxane   <10.92  
Acetone   0.18   D10  Siloxane   <21.86  
17   Contains Nonbinding Recommendations  
 
 
Isopropanol   0.26   D11  Siloxane   32.92  
2-Pentanone   ND   D12  Siloxane   47.85  
Methyl  Butanoate   0.01   D13  Siloxane   113.11  
Ethylbenzene   ND   D14  Siloxane   172.4  
m- &  p-xylene   0.08   D15  Siloxane   203.8  
4-Methyl-3-penten-2-one   0.01   D16  Siloxane   584.9  
o-xylene   ND   D17  Siloxane   533.0  
Alpha-Pinene   ND   D18  Siloxane   429.4  
Cyclohexanone   ND   D19  Siloxane   609.9  
1-Ethyl-2-methylbenzene   0.01   D20  Siloxane   775.5  
Decane   ND   o-Xylene   <0.4  
Benzaldehyde   0.01   Siloxane   3.9  
1,3,5-Trimethylbenzene   0.01   Di(Ethylhexyl)  Phthalate   ND  
Limonene   0.01   Total  Extractables  (g/g)   <4086.7  
Undecane   0.35      
Acetophenone   0.01      
Dodecane   0.07      
Total  Volatiles   3.67      
 
Data  preceded  with  a <  symbol means  that  the  level  of  the  individual  component,  if present,  was  below  the  
method detection  limit  indicated.  ND=Not  detected.   
*ppm = parts  per  million  
 
3.   Heavy Metals Found in Breast Implants  
 
Heavy Metals  
Metal   Concentration (ppm)  
Antimony   0.014  
Arsenic   0.123  
Barium   0.001  
Beryllium   0.006  
Cadmium   0.002  
Chromium   0.028  
Cobalt   0.052  
Copper   0.025  
Lead   0.011  
18   Contains Nonbinding Recommendations  
 
 
Magnesium   0.391  
Mercury   0.004  
Molybdenum   0.001  
Nickel   0.050  
Platinum   0.299  
Selenium   0.069  
Silver   0.001  
Tin   0.004  
Titanium   0.033  
Vanadium   0.310  
Zinc   0.034  
 
19