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 information documents that should be provided to you by your physician. You should receive patient information documents that include 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 documents 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 confirms 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 the following conditions have not been adequately studied to determine whether the conditions put me at higher risk:
• Autoimmune disease (e.g., Hashimoto’s, 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

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 body’s ability to heal (e.g., diabetes, connective tissue disorder);
• Active smoker or a former smoker;
• Currently taking drugs that weaken the body’s 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;
• Conditions that interfere with wound healing or blood clotting (e.g., hemophilia, von Willebrand disease, factor V Leiden, hyperhomocysteinemia, protein C deficiency, antithrombin III deficiency, or systemic lupus erythematosus); or

 

I understand the following conditions have not been adequately studied to determine whether the conditions put me at higher risk:

• Autoimmune disease (e.g., Hashimoto’s, 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.

Risks of Breast Implant Surgery

I understand that there are risks of undergoing breast implant surgery. I understand that risks of undergoing breast implant surgery may include:

• breast pain (reported in up to 33% of patients1),

• skin or nipple areola sensitivity changes or loss (loss of nipple sensation reported in up to

• 18.1% of patients2, intense nipple sensation reported in up to 9.8% of patients2 and intense skin sensation reported in up to 7.6% of patients2),
• asymmetry (reported in up to 39.0% of patients2),

• impact of aging or weight change on size and shape of breast (may occur in saline procedures but specific rates are not publicly available in the Allergan clinical studies),
• infection requiring possible removal of implant (reported in up to 6.0% of patients2),
• swelling (may occur in saline procedures but specific rates are not publicly available in the Allergan saline clinical studies)
• scarring (scarring complications reported in up to 6.5% of patients2),
  
• fluid collections (seroma) (reported in up to 3.9% of patients2),
  
• hematoma (reported in up to 1.7% of patients2),
  
• tissue death of breast skin or nipple (tissue/skin necrosis reported in up to 3.6% of patients2),
  
• inability to breast feed (may occur but specific rates are not publicly available in the Allergan clinical studies),
  
• complications of anesthesia (may occur but specific rates are not publicly available in the Allergan clinical studies),
  
• bleeding (may occur but specific rates are not publicly available in the Allergan clinical studies)
  
• chronic pain (may occur but specific rates are not publicly available in the Allergan clinical studies)
  
• damage to surrounding tissue, such as muscle, nerves, and blood vessels (may occur but specific rates are not publicly available in the Allergan clinical studies)
  
• impact on imaging of breast tissue (may occur but specific rates are not publicly available in the Allergan clinical studies My physician has discussed these risks and has provided me with the patient information documents (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.

1 Based on the largest complication rate reported in the A95/R95 Clinical Study through 10 years of follow-up. See Sections 7.3 and 8.3 of the Natrelle® Saline Filled Breast Implants Patient Document Based on the largest complication rate reported in the A95/R95 Clinical Study through 5 years of follow-up. See Sections 7.3 and 8.3 of the Natrelle® Saline Filled Breast Implants Patient Document

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

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

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 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 may include: 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.

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 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. A causal link has not been established between breast implants and these reported health problems in children and more research is needed. I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.

3 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.

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 need a reoperation requiring the replacement or removal of my breast implant. As many as 20.2% of women who receive Allergan saline breast implants for augmentation had their implants removed within 10 years, but my implants may last for a shorter or longer period of time. (The percentage reported is from the 10-year A95/R95 Clinical Study for Natrelle Saline-filled breast implants

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 gel 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, and the expense may not be covered by my medical insurance.

I understand that there are rare case reports of silicone migrating from breast implants into tissues (e.g., chest wall, lymph nodes under the arm) and organs (e.g., liver, lungs It may not be possible to remove migrated silicone.

I understand that all breast implants can affect mammography and breast exams, which could potentially 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 III/IV)

• (reported in up to 51.7% of patients'),
• rupture or leaking of the implant (implant deflation reported in up to 22.5% of patients'),
• wrinkling of the implant (wrinkling/rippling reported in up to 24.6% of patients'),
• visibility of the implant edges (implant palpability/visibility reported in up to 27.1% of
  patients'),
  shifting of the implant (implant malposition reported in up to 16.9% of patients'), or
  reoperation (reported in up to 54.6% of patients'

I understand that I will receive a Device Identification 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, at some time in the future, I or my physician need to know what kind of implant I received many years later.

I understand that breast implant manufacturing requires the use of chemicals and heavy metals. I understand that most of these chemicals stay inside the shell of the implant. Small quantities may 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 section entitled, NATRELLE ® Silicone-Filled/Saline-Filled Breast Implant Device Materials” of the patient information document.

For silicone-gel filled implants, 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, an MRI is recommended.

I understand that for as long as I have my breast implant(s), I will need routine and regular follow-up with my physician, for examination of my breast implant(s) 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 there is a registry (PROFILE) where information is collected to better understand BIA-ALCL in patients with breast implants.

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.

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 surgeon, 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.

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 an 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.

Patient: I acknowledge that I have received and read the patient information documents 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 respective benefits and risks.

Physician: I acknowledge that I have discussed the benefits and risks of breast implants as described elsewhere in the patient information documents 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