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nat_patient_warranty_brochure

nat_patient_warranty_brochure

nat_patient_warranty_brochure

Product catalog summary
Natrelle® Breast Implants Warranty Program Overview
Important Safety Information: Breast implants are not lifetime devices and may lead to complications over time, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and systemic symptoms like joint pain and chronic fatigue. The risk of these complications is not fully established.
Warranty Coverage: The Natrelle® ConfidencePlus® warranty provides extensive coverage for both gel and saline implants, including lifetime replacement for ruptures and deflations, financial assistance for certain complications, and options for implant upgrades.
Gel Implant Warranty: Covers implant rupture and capsular contracture for up to 10 years, with financial assistance available. Late seroma and BIA-ALCL diagnostic testing and treatment are also covered.
Saline Implant Warranty: Includes lifetime replacement for deflation and options to upgrade to gel implants. Financial assistance is available for deflation incidents.
Eligibility and Claims: Coverage applies to FDA-approved Natrelle® implants used as intended by qualified surgeons. Claims require documentation and return of explanted implants. Certain events, like dissatisfaction with size or aesthetics, are not covered.
Safety Considerations: Breast implants are approved for augmentation and reconstruction in specific age groups. Surgery should not be performed on individuals with active infections, untreated cancer, or during pregnancy. Patients should disclose any conditions that may increase surgical risks.
Complications and Monitoring: Key complications include reoperation, implant rupture, and capsular contracture. Regular monitoring through imaging is recommended, especially for silicone implants, to detect silent ruptures.
Additional Information: Patients are advised to discuss potential complications with their doctor and report any issues to Allergan®. The sale of implants is restricted to licensed physicians who provide comprehensive risk and benefit information.
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Catalog excerpts

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WARRANTY PROGRAM WARRANTY PROGRAM Coverage for your Breast Implants Actual Natrelle® patients. Individual results may vary. Natrelle ® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES 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. Please see additional Important Safety Information on following pag

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GEL IMPLANT WARRANTY FREE coverage and automatic enrollment Rupture • Implant replacement: Lifetime for both affected and contralateral implants •O ut-of-pocket financial assistance: Up to $3,500 for 10 years Capsular contracture Baker Grade III/IV • Implant replacement: 10 years for both affected and contralateral implants Actual Natrelle® patients. Individual results may vary. •O ut-of-pocket financial assistance: Up to $2,000 for 2 years (augmentation patients only)* Late seroma Implant replacement: 20 years for both affected and contralateral textured implants. GEL BREAST IMPLANT WARRANTY...

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SALINE IMPLANT WARRANTY FREE coverage and automatic enrollment • Implant replacement: Lifetime for both affected and contralateral implants • Only Natrelle® offers free saline-filled implants to gel-filled implants replacement, including the contralateral replacement Actual Natrelle® patients. Individual results may vary. SALINE BREAST IMPLANT WARRANTY MORE Coverage MORE Confidence • Upgrade from saline-filled implants to Natrelle INSPIRA® SoftTouch or Natrelle INSPIRA® Cohesive Gel Breast Implants for only $100 per implant WARRANTY Program PREMIER SALINE IMPLANT WARRANTY For patients with Natrelle®...

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Products covered The ConfidencePlus® warranty program applies to all FDA-approved Natrelle® Breast Implants, provided the products have been used: • As intended by appropriately qualified and licensed surgeons and in accordance with current and accepted plastic surgery techniques • In accordance with the current Natrelle® Breast Implant Directions for Use, found at rxabbvie.com Events covered • Loss of shell integrity resulting in implant rupture of gel implants that requires surgical intervention • Loss of shell integrity resulting in implant deflation of saline-filled implants that requires...

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Natrelle® IMPORTANT SAFETY INFORMATION (continued) Natrelle ® Breast Implants are approved for the following: • Breast augmentation for women at least 22 years old for silicone-tilled implants and for women at least 18 years old for saline-tilled implants. Breast augmentation includes primary breast augmentation to increase the breast size and revision surgery to correct or improve the result of a primary breast augmentation • Breast reconstruction. This includes primary breast reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop...

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All Allergan - Natrelle catalogs and technical brochures

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    12  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.