Inamed ConfidencePlus & ConfidencePlus
Breast Implant Warranties

This document describes INAMED Aesthetics’ Saline-Filled and Silicone-Filled Breast Implant Limited Warranties described later in this document. The Breast Implant Limited Warranties consist of the ConfidencePlus® Warranty and the ConfidencePlus® PlatinumWarranty.

The INAMED ConfidencePlus® Warranty applies automatically to INAMED Style, Saline-Filled and Silicone-Filled Breast Implants, implanted in the United States or Canada on or after April 1, 2002, and supersedes the INAMED ConfidencePlus® Program, which became effective as of date of implant June 1, 1993. Eligible patients implanted from June 1, 1993, through March 31, 2002, remain covered under the terms and conditions stated in the INAMED ConfidencePlus® Program. The INAMED ConfidencePlus® Platinum Warranty applies to INAMED Style, Saline-Filled and Silicone-Filled Breast Implants, implanted in the United States or Canada on or after April 1, 2002 when an additional $100 fee has been paid to INAMED by or on behalf of the patient as specified in Section A(2) below.

Deflation and rupture are among the known risks of breast implants. The surgeon, as learned intermediary, is responsible for providing the patient with appropriate risk information before surgery, including (but not limited to) the risk of deflation and rupture. INAMED makes available to all surgeons and patients a copy of its Making An Informed Decision Brochure. Copies can also be obtained by contacting INAMED directly, or through the INAMED web site. The surgeon should also advise the patient about possible adverse reactions and complications associated with Saline-Filled and Silicone-Filled Breast Implants. This document is not intended to, and cannot, take the place of a full and candid discussion between surgeon and patient.

Under the INAMED ConfidencePlus® Warranty and the ConfidencePlus® Platinum Warranty, INAMED will replace qualified INAMED Style Breast Implants and pay, up to defined maximum amounts, certain uninsured out-of-pocket costs directly related to necessary revision surgery, in each case by reason of a Covered Event and all as set forth below. Qualified INAMED Style Breast Implants are the following:

Saline Filled Breast Implants: Style 68HP, 68MP, 68LP, 163, 168, 363LF, 468

Silicone Filled Breast Implants: Style 10, 15, 20, 40, 45, 110, 115, 120, 410 (all cells)

A. Application of the INAMED ConfidencePlus® and ConfidencePlus®

Platinum Warranties

1. The INAMED ConfidencePlus® Warranty: The INAMED ConfidencePlus® Warranty applies only to the qualified INAMED Style Saline-Filled and Silicone-Filled Breast Implants listed above, implanted in the United States or Canada on or after April 1, 2002. The INAMED ConfidencePlus® Warranty shall not apply to any implantations performed without strict accordance to current INAMED product literature (including product package enclosures, data sheets, and other notifications or instructions published by INAMED) and accepted plastic surgical procedures by appropriately qualified licensed surgeons.

2. The INAMED ConfidencePlus® Platinum Warranty: The INAMED ConfidencePlus® Platinum Warranty applies only to the qualified INAMED Style Saline-Filled and Silicone- Filled Breast Implants listed above, implanted in the United States or Canada on or after April 1, 2002 when a non-refundable fee of $100 has been received by INAMED to enroll the patient in the program. Whether paying by credit card, certified check or money order, the $100 payment must be either received or postmarked within 30 days of the qualifying implantation surgery. The INAMED ConfidencePlus® Platinum Warranty shall not apply to any implantations performed without strict accordance to current INAMED product literature (including product package enclosures, data sheets, and other notifications or instructions published by INAMED) and accepted plastic surgical procedures by appropriately qualified licensed surgeons.

3. Covered Events: The INAMED ConfidencePlus® Warranty, and the INAMED ConfidencePlus® Platinum Warranty apply only to the following covered events (each a “Covered Event”) if they require surgical intervention:

(a) deflation of INAMED Style Saline-Filled Breast Implants due to crease fold failure;

(b) loss of shell integrity from unknown cause; or (c) loss of valve integrity;

or

(a) rupture of INAMED Style Silicone-Filled Breast Implants due to crease fold failure; or

(b) loss of shell integrity from unknown cause.

The INAMED ConfidencePlus® Warranty and the INAMED ConfidencePlus® Platinum Warranty may also apply to other event-related losses of shell integrity not specifically excluded, subject to review and approval by INAMED.

4. Events Not Covered: The INAMED ConfidencePlus® Warranty and the INAMED ConfidencePlus® Platinum Warranty do not apply to (a) removal of intact implants for capsular contracture; (b) removal of intact implants for size alteration; (c) removal of intact implants due to wrinkling or rippling; (d) loss of shell integrity caused by operative procedures; (e) loss of shell integrity resulting from open capsulotomy or closed compression capsulotomy procedures.

The INAMED ConfidencePlus® Warranty and the INAMED ConfidencePlus® Platinum Warranty exclude other events outside the covered events listed in section A(3) above.

 

B. What INAMED will provide under the INAMED ConfidencePlus® Warranty, and the INAMED ConfidencePlus® Platinum Warranty

1. Product Replacement: If patient has a Covered Event, INAMED will replace the qualified INAMED product with another INAMED product, of the same or similar type as the qualifying product, free of charge for the lifetime of the patient. Implantation of the replacement INAMED product, as well as any subsequent procedures, must be in strict accordance with current INAMED product literature and accepted plastic surgical procedures by appropriately qualified licensed surgeons for such product to qualify for replacement. Should a more expensive product be requested by the surgeon, INAMED will invoice the ordering customer for the list price difference between the qualified product to be replaced and the requested replacement product. The customer will not be credited or reimbursed for the list price difference between the qualified product to be replaced and the requested replacement product should the surgeon request a less expensive replacement product.

The explanted product must be returned to the INAMED Device Analysis Laboratory within 90 days of its explant in order to qualify for the free of charge replacement product. In the event that the explanted product is not returned to the INAMED Device Analysis Laboratory within 90 days of its explantation, the ordering customer will be invoiced for the price of the replacement product. Qualifying replacement product will be sent without shipping charges. INAMED will neither provide nor pay for a non-INAMED product, nor in any event provide money for or in lieu of an INAMED replacement product. Any replacement INAMED Style, Saline-Filled or Silicone-Filled Breast Implant, automatically includes a new INAMED ConfidencePlus® Warranty covering the replacement implant only.

Limitation on Product Replacement: If INAMED’s obligation to provide a replacement product under either the INAMED ConfidencePlus® Warranty or ConfidencePlus® Platinum Warranty is prevented, restricted, or interfered with by reason of fire, flood, earthquake, explosion, or other casualty or accident, strikes or labor disputes, inability to procure supplies or power, war or other violence, any law, order, proclamation, regulation, ordinance, demand, or requirement of any government agency, or any other act or condition whatsoever beyond the reasonable control of INAMED, the performance of that obligation shall be excused without penalty. For purposes of this provision, excuse of performance shall mean that INAMED is neither obligated to provide nor pay for a replacement product, regardless of the product’s source. Despite the excuse of INAMED’s obligation to provide a replacement product under this provision, INAMED shall continue to perform its obligation to provide financial assistance for operating room, anesthesia, and surgical fee costs to the extent described under the INAMED ConfidencePlus® and ConfidencePlus® Platinum Limited Warranties.

2. The INAMED ConfidencePlus® Warranty: Under the INAMED ConfidencePlus® Warranty, when a qualifying replacement surgery for a Covered Event occurs within 10 years from the date of implantation, INAMED will pay out-of-pocket expenses for surgical fees, operating room, and anesthesia expenses directly related to revision surgery and not covered by insurance, up to a maximum aggregate amount of $1,200. Upon submission of a qualifying request, INAMED will provide a general release in favor of INAMED Aesthetics. INAMED will not pay for any re-operative expenses until receipt of the release signed by the patient. In addition, INAMED may require a copy of bills or receipts associated with the revision surgery before payment will be made. Other documentation, such as operative notes, may be required prior to payment. Request for financial assistance under the INAMED ConfidencePlus® Warranty must be made to the Product Support Department prior to the date of qualifying revision surgery.

3. The INAMED ConfidencePlus® Platinum Warranty: Under the INAMED ConfidencePlus® Platinum Warranty, when a qualifying replacement surgery for a Covered Event occurs within 10 years from the date of implantation, INAMED will pay out-of-pocket expenses for surgical fees, operating room, and anesthesia expenses directly related to revision surgery and not covered by insurance up to a maximum aggregate amount of $2,400. At the surgeon’s request, INAMED will also provide a replacement of a INAMED Style, Saline-Filled or Silicone-Filled Breast Implant to use to replace the contralateral implant. Upon submission of a qualifying request for financial assistance, INAMED will provide a general release in favor of INAMED Aesthetics. INAMED will not pay for any re-operative expenses until receipt of the release signed by the patient. In addition, INAMED may require a copy of bills or receipts associated with the revision surgery before payment will be made. Other documentation, such as operative notes, may be required prior to payment. If the contralateral side is being replaced, return of both explanted implants is required. Request for financial assistance under the INAMED ConfidencePlus® Platinum Warranty must be made to the Product Support Department prior to the date of qualifying revision surgery. INAMED’s obligations under the INAMED ConfidencePlus® Platinum Warranty are complete upon full or partial payment of the financial assistance outlined in Section B.3. of this document. For the qualifying replacement implant to be eligible for the INAMED ConfidencePlus® Platinum Warranty, an additional payment of $100 is required. When a patient undergoes a unilateral Breast Implant replacement, and the INAMED ConfidencePlus® Platinum Warranty is purchased for the qualifying replacement implant, the terms of the original INAMED ConfidencePlus® Platinum Warranty will automatically continue to apply to the contralateral implant (not replaced) for the remainder of the ten years still available under its original term. This is contingent upon the contralateral implant qualifying under the terms of the INAMED ConfidencePlus® Platinum Warranty. Under no circumstances will the INAMED ConfidencePlus® Platinum Warranty continue for more than ten years from the actual date of implantation for any individual implant.

When INAMED has made payment for a unilateral replacement under the terms of the INAMED ConfidencePlus® Platinum Warranty, and the patient does not elect to purchase the INAMED ConfidencePlus® Platinum Warranty for the replacement implant, the assistance available for the contralateral implant (not replaced) is limited to any assistance that may still be remaining under the terms of the original INAMED ConfidencePlus® Platinum Warranty.

The assistance available under the terms of the INAMED ConfidencePlus® Platinum Warranty and the INAMED ConfidencePlus® Warranty or the INAMED ConfidencePlus® Program (for patients implanted between June 1, 1993 and March 31, 2002) is not cumulative. Payment made under the INAMED ConfidencePlus® Platinum Warranty completes any obligations of INAMED still remaining under the INAMED ConfidencePlus® Warranty and vice versa. The INAMED ConfidencePlus® Platinum Warranty is not transferable.

C. Patient Information on the INAMED ConfidencePlus® Warranty and the INAMED ConfidencePlus® Platinum Warranty

1. Before implantation surgery, the surgeon should explain the details of the INAMED ConfidencePlus® Warranty, and the INAMED ConfidencePlus® Platinum Warranty, including product replacement, to the patient, and provide the patient with a copy of this document. In addition to explaining the terms of Product Replacement, the INAMED ConfidencePlus® Warranty and the INAMED ConfidencePlus® Platinum Warranty, the surgeon should also advise the patient about possible adverse reactions and complications associated with Saline-Filled and Silicone-Filled Breast Implants, and review with the patient the Making An Informed Decision Brochure provided by Inamed.

D. Filing a Claim

1. If an Event occurs within ten years of the date of an implantation qualifying under the INAMED ConfidencePlus® Warranty, or the INAMED ConfidencePlus® Platinum Warranty, the surgeon should contact INAMED’s Product Support Department to obtain a return kit and instructions prior to revision surgery at (800) 624-4261 or (805) 683-6761. Once revision surgery occurs, send (a) a copy of the Returned Goods Authorization (RGA); (b) the patient’s completed general release form; (c) and the removed and decontaminated INAMED product. This information should be sent to:

INAMED Aesthetics
Device Analysis Laboratory
71 S. Los Carneros Rd.
Goleta, CA 93117

Upon receipt of the returned product, and of the properly signed release, a check will be issued to the appropriate party or parties in accordance with limitations outlined in this document. The check will be made payable to the party or parties indicated by the patient on the release form. Replacement products may be ordered before surgery by contacting INAMED’s Product Support Department in Santa Barbara, CA at (800) 624-4261 or (805) 683-6761.

INAMED Aesthetics reserves the right to cancel, change, or modify the terms of the INAMED ConfidencePlus® Warranty and/or the INAMED ConfidencePlus® Platinum Warranty. Any such cancellation, change, or modification will not affect the currently stated terms for those already enrolled in the Program. INAMED, the INAMED logo and ConfidencePlus are registered trademarks of INAMED Corporation and its affiliates.

©Just Breast Implants -  Your Complete Guide to Breast Augmentation and Breast Implants - 2001 - Present
All Rights Reserved.
Terms of Service/Usage Agreement