Gel-Filled Breast Implant Limited Warranty

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Please note: the information on this page is effective only for surgeries with Mentor gel-filled breast implants prior to May 1, 2005.

Click here for limited warranty information for all surgeries after May 1, 2005.

The following information provides an overview of Mentor's Limited Warranty program for gel-filled breast implants. However, it is not intended to replace any discussion between the surgeon and patient. Prior to surgery, every physician should:

• Explain to patients the full details of the Mentor breast implant limited warranty and provide them with a copy of this policy.
• Advise patients about possible risks and complications associated with breast implant surgery, which include deflation and rupture.

What Does The Limited Warranty Cover?

The limited warranty covers patients' uninsured, out-of-pocket costs that are directly related to breast implant revision surgery. When the limited warranty applies, Mentor provides the following:

Free Lifetime Replacement

Throughout a patient's lifetime Mentor will replace, at no cost, the same or a similar type of Mentor breast implant when implant replacement is required. If a more expensive product is requested, Mentor will invoice the surgeon for the price difference.

Financial Assistance

For the first five years following a breast implant procedure, Mentor will provide financial assistance up to $1,200 per revision surgery to help cover operating room expenses and anesthesia expenses not covered by insurance.

What Products Are Covered?

The Mentor breast implant limited warranty automatically applies to all Mentor silicone-gel-filled mammary implants that are implanted in the United States and Canada after October 1, 1998, provided these implants have been:

• Implanted in accordance with Mentor literature, current to the date of implantation, and other notifications or instructions published by Mentor.
• Used by appropriately qualified, licensed surgeons, in accordance with accepted surgical procedures.

What Events Are Covered?

The Mentor breast implant limited warranty applies to the following:

• Rupture due to crease fold failure, patient trauma or unknown cause.
• Loss of valve integrity from a Becker prosthesis.
• Rupture of any Mentor gel or Becker prosthesis.

Other loss-of-shell-integrity events also may be covered by this limited warranty. A physician retained by Mentor will determine if specific, additional events should be covered. However, events listed below in the "What Events are Not Covered?" section will not be covered.

What Events Are NOT Covered?

The Mentor breast implant limited warranty does not cover the following:

• Removal of intact implants due to capsular contracture, wrinkling or rippling.
• Loss of implant shell integrity resulting from reoperative procedures, open capsulotomy, or closed compression capsulotomy procedures.
• Removal of intact implants for size alteration.

How are Claims Filed?

To file a limited warranty claim for covered events, the surgeon must contact Mentor's Consumer Affairs Department.

Prior to reimbursement for revision surgery, the surgeon must complete all forms and requested documentation about medical treatments and expenses.

This is a summary of the Mentor Product Replacement Policy and Limited Warranty. It is an overview only and not a complete statement of the limited warranty. You may obtain a copy of the complete Limited Warranty for Mentor gel-filled breast implants by writing to:

Consumer Affairs Department
Mentor
201 Mentor Drive
Santa Barbara, CA 93111 USA

Effective October 1, 1998