Breast Implant Patient Decision Checklist

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 understand that if I have any of the following conditions, I may be at a higher risk for a poor surgical outcome: 

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

Patient Initials: __________ 

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:  

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 (BIAALCL). Information regarding the number of medical device reports of BIA-ALCL can be found on FDA’s website.  I have received information regarding the overall incidence rates of BIAALCL 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: __________ 

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.  

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: 

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 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: __________ 

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. 

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 

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 

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). 

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