PSPS

PSPS stands for the Silimed® Product Replacement Program, which provides for breast implant replacement in confirmed cases of rupture resulting from a manufacturing defect or Baker grade III or IV capsular contracture, in accordance with the criteria and time frames established by the program.

Following breast implant placement, the body naturally forms a capsule of tissue around the implant. In some patients, this capsule may contract, causing breast firmness, changes in breast shape and, in some cases, pain. This condition is known as capsular contracture and is classified into four grades according to the Baker scale. The PSPS covers cases of Baker grade III or IV capsular contracture, provided that all other program conditions are met.

Silimed® replaces True Texture®, Pure Polyurethane® and Soft Plus® breast implants in the following situations:

• Implant rupture due to a manufacturing defect: lifetime replacement is provided when it is confirmed that the rupture resulted from a manufacturing defect.

• Baker grade III or IV capsular contracture: replacement may be requested within 10 years from the date of surgery in cases of primary breast augmentation or the first breast reconstruction surgery.

• The 10-year period applies to Silimed® breast implants regardless of their surface: True Texture®, Pure Polyurethane® or Soft Plus®.

The replacement provided under the PSPS applies exclusively to the product. The program does not cover hospital expenses, medical fees, anesthesia, medication or any other costs related to the surgical procedure.

The replacement implant will have the same surface as the product originally purchased but may be a different size. If the original product is no longer manufactured, the most similar implant available will be provided.

• Imaging examinations and/or photographs providing initial evidence of the event

• A signed medical report describing the case

• A physical copy of the Patient Card provided during or after surgery

All submitted documents must be complete and legible.

• Dissatisfaction with the implant size or aesthetic outcome

• Implant rupture caused by circumstances other than a manufacturing defect, such as an accident during surgery or a mammogram

• Baker grade I or II capsular contracture

• Failure to provide imaging examinations and/or photographs and a medical report as initial evidence

• Failure to provide a physical copy of the Patient Card

• Non-primary surgeries, such as revision surgery, seroma, or reoperation for any other reason

• Costs related to the surgical procedure (hospital expenses, medical fees, anesthesia, medication, etc.)