NATRELLE ® Saline-Filled Breast Implant Patient Decision Checklist 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. The sale and distribution of this device is restricted to users and/or facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Aller

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...

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. Patient Initials:_ I understand that there...

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 FDA’s website.3 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,...

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 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...

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. Patient Initials: __________ Recommended Follow-up 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...

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. 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...

SCAN TO REVIEW NATRELLE® Saline-Filled Breast Implant Full Brochure (Augmentation and Reconstruction)

SCAN TO REVIEW NATRELLE® Saline-Filled Breast Implant Full Brochure (Augmentation and Reconstruction) Allergan Sales, LLC 2525 Dupont Drive Irvine, CA 92612 1.800.624.4261 © 2022 Allergan. All rights reserved. All trademarks are the property of their respective owners. Patented. See: https://www.abbvie.com/allergan-patent-notices.html www.allergan.com