Contact us
Contact customer service at 1.800.367.5737 or email PRMorder@allergan.com
See our new privacy terms at https://privacy.abbvie/.
The combined use of the plastic and regenerative medicine portfolio of products has not been studied.
Plastic & Regenerative Medicine Portfolio
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1. Data on file, Allergan Aesthetics, December 2023; Plastic Surgery Aesthetic Monthly Tracker: Breast Implants, Tissue Expanders, Surgical Scaffolds, and Fat Transfer. 2. Data on file, Allergan Aesthetics, July 2023; Surgical Scaffold AU Surgeon Perceptions 2023.
Services + Accountability + Education = Value
The Allergan Aesthetics Plastic and Regenerative Medicine (PRM) portfolio provides high-value services, accountability, and education.
Services
Multiple products
on one contract
Multiple modes
of delivery
Automatic Shipping and
Accessible Stock
- All products automatically shipped without fees to meet your cases
- Tissue products automatically shipped priority overnight
- 19 managed stocking locations available nationwide for the Natrelle® Breast Implant portfolio1
Versatile Stocking/
Inventory Management
Multiple Inventory and Ordering Options
- Direct purchase
- Consignment
- Provisional stock program (PSP)
- Allergan Direct Online ordering
Personalized support of enhanced consignment program
Reliable, On-Demand Access
- Availability of product when your surgeons need it
- Pay for products only after use with one simple invoice
Replenished Stock
- Continual replenishment of consigned stock to contract specifications to lessen direct purchases & returns
Product Rotation
- Inventory audited frequently by Allergan Aesthetics to check shelf life and ensure timely rotation of product
Inventory Analysis
- Consumption patterns reviewed annually to optimize inventory levels
Top-notch medical education
for your surgeons and staff
High-Value Training Opportunities
- A variety of programs for surgeons and staff designed to advance scientific knowledge and technical skills to help improve outcomes
- State-of-the-art virtual reality surgical training
- Live/virtual/on-demand training options
- Programs dedicated to residents and young surgeons
- 90 surgical programs with 1800 surgeons and staff trained in 20222
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1. Data on file, Allergan Aesthetics, February 15, 2024; Allergan Managed Stocking Locations. 2. Data on file, Allergan Aesthetics, 2023; Corporate Healthcare PRM Value Deck Slide Library.
Support
Highly credentialed experts to support customers every step of the way
- Customer service support line
- Field and hotline reimbursement support
- Medical affairs for surgeon support
- Dedicated field sales team
- Contracting team and support
Robust reimbursement support and coverage solutions
- Appeals assistance
- Coding (physician, facility)
- Coverage and payment assistance reimbursement
- Education and health policy
- Prior authorization
- Processing support
- Call 1.888.543.3656 or email us
Medical Affairs Support
- Our experienced field-based Medical Science Liaisons (MSLs) are available to provide scientific and clinical information on your surgeon's request
- For assistance call 1.800.678.1605 option 2, or email us
Trusted and Studied Portfolio
with decades of clinical experience1-10
#1 selected acellular dermal matrix (ADM) among surveyed plastic surgeons11,*
- 30+ years and the market leader6,11,*
- Most published ADM: Over 1,000 publications2,12
- Over 4 million implantations with zero reports of disease transmission12,13
- 200+ high-commitment agreements across US healthcare systems14
- 100% product replacement guarantee12
Next advancement in porcine-derived ADM for plastic and reconstructive surgery
- Harnessing 30 years of experience processing dermal tissue7
- Offers similar biologic response, more consistency and less stretch than human ADM14
- Correlation of these results to results in humans has not been established. Clinical significance is unknown
- 100% product replacement guarantee
#1 selected biologic for ventral hernia repair11,*
- 15+ years and the market leader10,11,*
- Highly published: 150 publications4
- Over 300K implantations15
- 100% product replacement guarantee
- 200+ high-commitment agreements across US healthcare systems16
#1 selected breast implant and tissue expander11,*
- 35+ years and the market leader5,11,*
- Most published breast implant: 84 peer-reviewed studies1
- Low 10-year complication rates17
- Most comprehensive smooth implant portfolio18
- Natrelle® ConfidencePlus® Warranty
#1 commercial device for fat processing11,*
- 10+ years and the market leader in the US for aesthetic and reconstructive surgery9,11,*
- 175K+ patients treated19
- Used by 2000+ Hospitals and Surgical Centers20
- High-quality fat in less time21-24,†, ‡
#1 implant sleeve11,*
- 96% of plastic surgeons would recommend to a colleague25
*Based on surgeon survey data as of December 2023. AlloDerm™ (n = 238); KELLER FUNNEL® (n = 292); Natrelle® (n = 500); REVOLVE™ (n = 98); STRATTICE™ (n = 136).
†Correlation between these results and results in humans has not been established.
‡Retrospective study of patients with fat grafts processed by centrifugation (n = 96) and REVOLVE™ System (n = 98). Endpoints included volume injected after processing and time to complete (from lipoaspiration to fat injection); grafting rate reflects volume of fat injected over the time taken to complete procedure.23
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1. Data on file, Allergan Aesthetics, June 2022; Library Information Science, Number of Natrelle® Studies. 2. Data on file, Allergan Aesthetics, November 2023; Library Information Science, Number of AlloDerm™ Studies. 3. Data on file, Allergan Aesthetics, February 13, 2024; Library Information Science, Number of Artia™, Keller Funnel®, and Revolve™ Studies. 4. Data on file, Allergan Aesthetics, December 2023; Library Information Science, Number of Strattice™ Studies. 5. Data on file, Allergan Aesthetics, July 15, 1986; McGhan Magna-Site® Tissue Expander 510(k) (K862203). 6. LifeCell Corporation Second Quarter Results Press Release, August 1994. 7. Data on file, Allergan Aesthetics, December 19, 2014; HP Tissue Matrix 510(k) (K14326). 8. Data on file, June 2017, Allergan Aesthetics; Keller Funnel Acquisition 9. Data on file, Allergan Aesthetics, December 22, 2016; Revolve ENVI 600 Advanced Adipose System 510(k) (K163647). 10. Data on file, Allergan Aesthetics, June 11, 2007; LTM Surgical Mesh 510(k) (K070560). 11. Data on file, Allergan Aesthetics, December 2023; Plastic Surgery Aesthetic Monthly Tracker: Breast Implants, Tissue Expanders, Surgical Scaffolds, and Fat Transfer. 12. Data on file, Allergan Aesthetics; AlloDerm Guarantee. 13. Data on file, Allergan Aesthetics, October 31, 2023; AlloDerm™ Global Product Sales. 14. Data on file, Allergan Aesthetics, 2023; Corporate Healthcare PRM Value Deck Slide Library. 15. Data on file, Allergan Aesthetics, 2023; Total Strattice™ Units Sold. 16. Data on file, Allergan Aesthetics, November 2022; Total Tissue Value Messaging Executive Summary. 17. Natrelle® Silicone-Filled Breast Implants and Natrelle INSPIRA® Smooth Breast Implants Directions for Use, 2022. 18. Data on file, Allergan Aesthetics, January 2022; Allergan Plastic Surgery Order Form. 19. Data on file, Allergan Aesthetics, 2022; REVOLVE System Sales Data, Patients Treated. 20. Data on file, Allergan Aesthetics 2022; REVOLVE™ System Sales Data, Accounts. 21. Fang C, Patel P, Li H. Physical, biochemical, and biologic properties of fat graft processed via different methods. Plast Reconstr Surg Glob Open. 2020;8:e3010. 22. Ansorge H, Garza JR, McCormack MC, et al. Autologous fat processing via the Revolve system: quality and quantity of fat retention evaluated in an animal model. Aesthet Surg J. 2014;34(3):438-447. 23. Gabriel A, Maxwell GP, Griffin L, Champaneria MC, Parekh M, Macarios D. A comparison of two fat grafting methods on operating room efficiency and costs. Aesthet Surg J. 2017;37(2):161-168. 24. Hanson SE, Garvey PB, Chang EI. A randomized prospective time and motion comparison of techniques to process autologous fat grafts. Plast Reconstr Surg. 2021;147(5):1035-1044. 25. Data on file, Allergan Aesthetics, October 2017; Plastic Surgery Monthly Tracker.
Accountability
Business Continuity
AbbVie's supply chain is consistently ranked as a global supply chain leader because we:
- Ensure patients and customers receive uninterrupted supply of products they need, even in unpredictable circumstances
- Identify and qualify backup suppliers, scan the environment for potential risks, and perform scenario planning
- Regard quality and integrity of our supply chain as our top priorities, with criticality assessment, controls, relationship management, and continuous monitoring
- Ranked #20 in the Gartner Supply Chain Top 25 in 20221
Advancing Environmental Sustainability
- Committed to a 42% reduction of our absolute scope 1 and 2 GHG emissions by 20302
- From our 2015 baseline year, 20% reduction in waste generation2
- AbbVie received Energy Star partner of the year in 2022 and 20233,4
- Our tissue is manufactured at a zero landfill site and is the only tissue facility to receive an Energy Star certification3,5
Diverse and Inclusive Culture
- Embracing equity, equality, diversity, and inclusion is fundamental to who we are
- Ranked #16 in the Fair360.com Top 50 Companies for Diversity in 20236
- 198K+ U.S. patients gained access to medicine and product at no cost through our patient assistance program2
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1. Gartner 2022 Rankings, Global Supply Chain Top 25, May 26, 2022. Accessed February 8, 2024, at: https://www.gartner.com/en/newsroom/press-releases/2022-05-26-gartner-announces-rankings-of-the-2022-global-supply-chain-top-25. 2. Data on file, Allergan Aesthetics, 2023; Environmental, Social, and Governance (ESG) 2022 Highlights. 3. 2022 Energy Star Awards, Profiles in Leadership. 4. 2023 Energy Star Awards, Profiles in Leadership. 5. Data on file, Allergan Aesthetics, July 6, 2022; Zero Landfill Manufacturing. 6. Fair360 2023 Rankings, Top 50 Companies for Diversity, 2023. Accessed March 8, 2024 at: https://www.fair360.com/top-50-list/2023/.
ALLODERM SELECT™ Regenerative Tissue Matrix
ALLODERM SELECT RESTORE™ Regenerative Tissue Matrix
Indications and Important Safety Information
INDICATIONS
ALLODERM SELECT™ Regenerative Tissue Matrix (ALLODERM SELECT™ RTM refers to both ALLODERM SELECT™ RTM and ALLODERM SELECT RESTORE™ RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. ALLODERM SELECT™ RTM is intended for use in post-mastectomy breast reconstruction surgical procedures where the use of the acellular dermal matrix (ADM) is considered homologous, such as managing a potential skin defect created from harvesting tissue for use in autologous tissue reconstruction. Examples of uses in post-mastectomy breast reconstruction not considered homologous include use of an ADM to form an extension of the submuscular pocket for placement of a breast implant or tissue expander, and use to prevent expander or implant extrusion, or to constrain the expander or implant in the correct position. This product is intended for use in one patient, on a single occasion. ALLODERM SELECT™ RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ALLODERM SELECT™ RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.
WARNINGS
Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECT™ RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECT™ RTM.
DO NOT re-sterilize ALLODERM SELECT™ RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK”. DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECT™ RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.
PRECAUTIONS
Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECT™ RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.
ALLODERM SELECT™ RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.
ALLODERM SELECT™ RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (eg, physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECT™ RTM.
ADVERSE EVENTS
Potential adverse events which may result from surgical procedures associated with the implant of a tissue graft include, but are not limited to, the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.
ALLODERM SELECT™ RTM is available by prescription only.
For more information, please see the Instructions for Use (IFU) for ALLODERM SELECT™ RTM.
To report an adverse reaction, please call Allergan Aesthetics at 1.800.433.8871.
ARTIATM RECONSTRUCTIVE TISSUE MATRIX
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
ARTIA™ Reconstructive Tissue Matrix (ARTIA™ RTM) is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery. ARTIA™ RTM is supplied sterile and is intended for single patient, one time use only.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
This product should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.
WARNINGS
Do not resterilize. Discard all open and unused portions of this device. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. Do not use if the temperature monitoring device does not display “OK.” After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. ARTIA™ Tissue Matrix cannot be reused once it has been removed from the packaging and/or is in contact with a patient without increased risk of patient-to-patient contamination and subsequent infection. The user should be aware of high recurrence rates when using a surgical mesh for bridging repair in load-bearing applications (eg, hernia repair).
PRECAUTIONS
Use of the product in breast reconstruction has not been studied in a prospective clinical trial.
Discard product if handling has caused possible damage or contamination, or the product is past the expiration date. Ensure the surgical mesh is soaked in room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place the product in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. The surgical mesh should be hydrated and moist when the package is opened. If the product is dry, do not use. If a tissue punch-out piece is visible, remove using aseptic technique before implantation.
Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.
Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh.
ARTIA™ RTM is available by prescription only.
For more information, please see the Instructions for Use (IFU) for ARTIA™ RTM.
For product complaints and potential adverse events, please contact your local Sales Representative, or 1.800.433.8871.
STRATTICE™ RECONSTRUCTIVE TISSUE MATRIX (RTM), STRATTICE™ RTM PERFORATED, STRATTICE™ RTM EXTRA THICK, AND STRATTICE™ RTM LAPAROSCOPIC
INDICATIONS
STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of these products include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. STRATTICE™ RTM Laparoscopic is indicated for such uses in open or laparoscopic procedures. These products are supplied sterile and are intended for single patient one-time use only.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.
WARNINGS
Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-to-patient contamination and subsequent infection.
For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.”
PRECAUTIONS
Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.
Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.
Presence of a significant microbial load may affect overall performance of surgical mesh. Utilize bioburden-reducing techniques to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy.
In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure.
For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation.
For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar.
STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only.
For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products.
To report an adverse reaction, please call Allergan Aesthetics at 1.800.367.5737.
REVOLVE™ Advanced Adipose System
Indications and Important Safety Information
INDICATIONS
The REVOLVE™ Advanced Adipose System (REVOLVE™ System) is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. This system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. REVOLVE™ System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Contraindications to autologous fat transfer include the presence of any disease processes that adversely affect wound healing, and poor overall health status of the individual.
WARNINGS
REVOLVE™ System must be used within the same surgical procedure. Reuse of this device in the same patient in a subsequent surgical procedure, or for more than one patient, may result in infection and/or transmission of communicable diseases. Do not use the product if sterile packaging is damaged.
This device will not, in and of itself, produce significant weight reduction. This device should be used with extreme caution in patients with chronic medical conditions such as diabetes, heart, lung, or circulatory system disease or obesity. The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely replacement is essential for patient safety.
PRECAUTIONS
REVOLVE™ System is designed to remove localized deposits of excess fat through small incision and subsequently transfer the tissue back to the patient. Use of this device is limited to those physicians who, by means of formal professional training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty and tissue transfer. Results of this procedure will vary depending upon patient age, surgical site, and experience of the physician. Results of this procedure may or may not be permanent. The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect. Filling the device with adipose tissue over the maximum fill volume line can lead to occlusion of the mesh resulting in mesh tear.
ADVERSE EFFECTS
Some common adverse effects associated with autologous fat transfer are asymmetry, over- and/or under-correction of the treatment site, tissue lumps, bleeding, and scarring. Potential adverse effects associated with REVOLVE™ System include fat necrosis, cyst formation, infection, chronic foreign body response, allergic reaction, and inflammation.
REVOLVE™ System is available by prescription only.
For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVE™ System available at www.allergan.com/REVOLVEIFU or call 1.800.678.1605.
To report an adverse reaction, please call Allergan at 1.800.367.5737.
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
- · Breast implants are not considered lifetime devices. The longer patients have them, the greater the chance 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
INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
- • Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants. This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
- • Breast reconstruction. This includes primary reconstruction 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. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery
CONTRAINDICATIONS
Breast implant surgery should not be performed in:
- • Women with active infection anywhere in their body
- • Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions
- • Women who are currently pregnant or nursing
ADDITIONAL WARNINGS
- • See Boxed Warning
- • Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants. Use care when using surgical instruments in proximity with the breast implant
- • Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure
PRECAUTIONS
Safety and effectiveness have not been established in patients with the following:
- • Autoimmune diseases (eg, lupus and scleroderma)
- • A compromised immune system (eg, currently receiving immunosuppressive therapy)
- • Planned chemotherapy or radiation following breast implant placement
- • Conditions or medications that interfere with wound healing and blood clotting
- • Reduced blood supply to breast tissue
- • Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery
ADVERSE EVENTS
Possible adverse events with breast implant surgery include implant rupture with silicone implants, implant deflation with saline-filled implants, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, infection, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy. Other systemic conditions have been reported with breast implants.
For more information, please see the full Directions for Use at www.allergan.com/products.
To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.
The sale and distribution of this device is restricted to users and/or user 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 Allergan®.