Silimed Product Replacement Program (PSPS)
Choosing Silimed will provide your patient with the peace of mind of purchasing safe and quality breast implants, which also offers a product replacement program in cases of rupture due to manufacturing defects or Baker grades III or IV capsular contractures.
After placement, silicone breast implants are naturally involved by a capsule of tissue, which is a normal reaction of the body. In some patients, this capsule becomes vigorous enough to harden the breast and even change its shape, giving it an unsightly, hardened, and sometimes painful shape. Therefore, it is a reactive manifestation of the body in the presence of a foreign body, which isolates it through the layer of tissue that forms around it, known as the fibrous capsule or fibrotic capsule. This reaction of the body is known as capsular contracture. There are four grades, as classified by Baker, and our program coverage includes grades III and IV.
What is the PSPS?
The PSPS is the Silimed Product Replacement Program, a product replacement program in the event of ruptured breast implants due to a manufacturing defect or Baker's grade III or IV capsular contracture.
What is the Capsular Contracture?
After placement, silicone implants are naturally involved by a capsule of tissue, which is a normal reaction of the body. In some patients, this capsule becomes vigorous enough to harden the breast and even change its shape, giving it an unsightly, hardened, and sometimes painful shape. This reaction of the body is known as capsular contracture.
How does the PSPS work?
Silimed replaces the breast implant in case of:
Rupture of the implant due to a manufacturing defect;
Capsular contracture Baker grades III or IV in primary augmentation surgeries or in the first breast reconstruction surgery, the implant will be replaced considering the following periods counted from the date of surgery. For the Soft Plus breast implant, the replacement will be exclusively for placement in the submuscular plane.
*Up to 10 years for surfical implantation of breast implants with textured surface (TRUE TEXTURE) performed on or after May 4th 2017 and up to 6 years for surgeries performed between September 1st 2014 and May 3rd 2017.
*Up to 10 years for polyurethane foam coated breast implants (PURE POLYURETHANE) and breast implants with the SOFT PLUS surface.
*It is necessary to check the availability of each product in your country.
What documents are required to apply for the PSPS?
- Imaging tests (ultrasound, tomography or magnetic resonance) - Stamped and signed medical report explaining the incident in detail - The invoice or patient card that follows inside the product package *All documents must be legible.
In what situations would I not be eligible for PSPS?
- Dissatisfaction with the size of the implant or the cosmetic result; - Rupture of the implant caused by reasons other than a manufacturing defect, such as: rupture caused during a mammogram, among others; - Contraction of Baker's capsule grade I or II; - When the event of rupture due to a manufacturing defect or a Baker grade III or IV capsule contracture does not have examination/photographs and medical report as initial evidence; - When the patient does not present a physical copy of the patient card provided during or after the surgery or a copy of the purchase invoice; - In the case of non-primary surgeries, that is, when it comes to revision augmentation, seroma or any other reason for reoperation.
How to contact us for any question?
If you still have questions, please contact SILIMED through our email address: firstname.lastname@example.org or 08009424199
- Product information available in the FLH 190 R00 03/2023 - PSPS