There are two FDA approved manufacturers of breast implants within the United States, Mentor™ and Allergan™. Each corporation has its own breast prosthesis warranty, with options for more extensive coverage. Both policies are quoted below.
“Mentor’s free Lifetime Product Replacement Policy involves the free lifetime product replacement for its gel-filled and saline-filled breast implants, worldwide. When implant replacement is required and the Mentor Product Replacement Policy applies (see below), Mentor will provide, throughout a patient’s lifetime, the same or similar Mentor breast implant at no cost. If a more expensive product is requested, Mentor will invoice the surgeon for the price difference.
The Mentor Standard Advantage Limited Warranty is free of charge to all patients who are implanted with Mentor gel-filled or saline-filled breast implants in the United States and Puerto Rico. When the limited warranty applies, Mentor provides the following:
- Financial assistance: For the first ten years following a breast implant procedure, Mentor will provide financial assistance up to $1200 to help cover operating room, anesthesia, and surgical charges not covered by insurance. Financial assistance applies to covered events only (see below). Operating room and anesthesia charges will be given payment priority. In order to qualify for financial assistance, the patient will need to sign a Release Form.
- Free contralateral (opposite side) implant replacement upon surgeon request.
- Non-cancelable terms.
The Mentor Enhanced Advantage Limited Warranty is an optional limited warranty available for women who are implanted with Mentor gel-filled or saline-filled breast implants in the United States and Puerto Rico. To be eligible, the Mentor Enhanced Advantage Limited Warranty must be purchased for an enrollment fee of $100 within 45 days from implantation. When the warranty applies, Mentor provides the following:
- Financial assistance: For the first ten years following a breast implant procedure, Mentor will provide financial assistance up to $2400 to help cover operating room, anesthesia, and surgical charges not covered by insurance. Financial assistance applies to covered events only (see below). Operating room and anesthesia charges will be given payment priority. In order to qualify for financial assistance, the patient will need to sign a Release Form.
- Free contralateral implant replacement upon surgeon request.
- Non-cancelable terms.
With both the Mentor Standard Advantage and Mentor Enhanced Advantage Limited Warranties, it is important for the patient to also maintain her own records to ensure validation of her enrollment.
Products Covered
The Mentor Standard Advantage Limited Warranty coverage applies to all Mentor gel-illed and saline-filled breast implants that are implanted in the United States and Puerto Rico, provided they have been:
- Implanted in accordance with the Mentor package insert, current to the date of implantation, and other notifications or instructions published by Mentor; and
- Used by appropriately qualified, licensed surgeons, in accordance with accepted surgical procedures.
Events Covered
The Mentor Lifetime Product Replacement Policy, and the Standard Mentor Advantage and Enhanced Advantage Limited Warranties coverages apply to the following:
- Rupture due to localized stress, folding, manufacturing defect, patient trauma, or unknown cause
- Other loss-of-shell integrity events, such as surgical damage may also be covered by these programs. Mentor reserves the right to determine if specific, additional events should be covered.
Events Not Covered
The Mentor Lifetime Product Replacement Policy and the Mentor Standard Advantage and Enhanced Advantage Limited Warranties coverages do not apply to the following:
- Removal of intact implants due to capsular contracture, or wrinkling.
- Loss of implant shell integrity resulting from reoperative procedures, open capsulotomy, or closed compression capsulotomy procedures.
- Removal of intact implants for size alteration.
Filing for Financial Assistance
- To file a Mentor Advantage claim for product replacement and/or financial assistance, the surgeon must contact the Mentor Product Evaluation Department at 1-866-250-5115 prompt #1 prior to replacement surgery.
- For financial assistance claims, a patient-specific Release form will be generated that the patient must sign and return.
- For either replacement or financial assistance claims, the surgeon must send the explanted, decontaminated Mentor breast impl
