Home | FAQ | Quality

Quality

1. What is silicone?

In the field of medicine, silicone is used in a variety of products: probes, catheters, tips for perforating needles and pace-makers. In the thin-tissue surgery field, implants are used to correct the body contour.
The first productive process of silicone polymers was patented in 1958.
Silicone, or dimethylpolysolixane in the language of chemists, is produced as silicone elastomer, silicone gel or silicone oil. In silicones, oxygen and silicon are linked in the same way as stones and glass. In addition, the methylic groups are linked to the silicon atoms. Except for amorphous silica as a stabilizing and filling material, silicone contains no other additive, and especially no softening agent.

2. Do silicone implants represent a health risk?

Silicone already exists to a reasonable extent in the blood stream of any living being who has had injectable medication, because this is the lubricant used in injection needles and medicine against gases, among other applications.
It has already been scientifically proved that silicone is, up to this date, the best material for manufacturing implantable products, serving not only for aesthetic purposes but also in reconstructing many parts of the body.

3. Do silicone implants offer any post-operatory risk?

In general, surgery of any nature can present unexpected problems. Likewise, any patient who undergoes surgery to introduce a foreign body into the organism is subject to possible complications. Also, a silicone implant, even properly manufactured and correctly implanted, does not have a useful-life limit established by the scientific community.

4. Are polyurethane mammary implants cancerigenic?

No. The idea that the TDA (a chemical also known as Toluenediamina 2,4) released by polyurethane might be cancerigenic was refuted even by the FDA after studies published by the North-American inspection agency in 1995 proved the contrary. This was even reported in the last announcement made by that agency with regard to polyurethane implants  

5. Have mammary implants coated with polyurethane foam been forbidden by the FDA?

No. This implant has never been forbidden by the FDA.

6. Can the silicone gel leak?

In comparison with first-generation implants, only insignificant traces of gel can be found in the capsular tissue. This is due to the proven quality both of the implant envelopes and the filling gel, which is highly cohesive and of low transudation.

7. What does cohesiveness mean?

OCohesiveness is the property that silicone gel molecules have of keeping linked together and not allowing the gel to ‘leak’ if the implant breaks. A common mistake is to confuse hardness with cohesiveness. What characterizes a cohesive gel are properties of elongation and memory, rather than hardness. A gel does not need to be hard to be cohesive.

8. Are implants assured to be safe?

Yes. For more than 30 years, the safety of and confidence in silicone implants have been continually assured in studies and experiments. National and international inspection organizations stipulate clear requirements for the manufacture of implants. Materials, development, manufacturing process, sterilization and packaging are all subjected to strict rules.
Mammary implants have been used since the early 60s. Since that time, over 2 million women decided to have silicone implants.
The implants are constantly being improved upon. Cooperation between patients, doctors and manufacturers has allowed us to make constant adaptations until we reached the current scientific and technological knowledge.
Breast augmentation is among the most common plastic-surgery operations performed.

9. Patient's card?

In order to offer even more security, Silimed provides a "patient's card" on each implant box for the surgeon or his/her team to place the labels with the serial and ref numbers and the volume of the implants used on each breast. Always carry this card with you to show for any reason, such as a mammography examination.

10. How should I prepare for a visit to my surgeon?

Ask your doctor anything you want to know. Prepare yourself for this conversation making a list of the doubts which occurred to you.
It is very important that you make sure of your choice, before the surgery.  

11. Why the different surfaces?

Due to a natural reaction of the human body, a capsule is formed around foreign bodies, including implants.
This capsule may become hard and contract the implant. The contracture may deform the implant and alter the shape of the breast. We call this complication capsular contracture. The incidence of capsular contracture is related, among other reasons, to the implant surface.
The first implants to be produced were smooth-surfaced. Polyurethane-foam-coated implants appeared in the middle of the seventies.
And finally in the 80s, textured implants appeared in an attempt to imitate the rugous effect of polyurethane foam.
Regardless of the modern techniques used, polyurethane implants resulted in remarkably low rates of capsular contracture, varying from 0 to 4%. Textured implants present a lower incidence of contracture than smooth implants.