Silimed Textured Implants
See the additional information section below for a list of all affected products.
Silimed textured implants. The risk of developing bia alcl was calculated to be 14 11 times higher in biocell textured implants and 10 84 times higher with polyurethane silimed textured implants compared with siltex. According to one forthcoming study silimed polyurethane textured implants pose a 23 times higher risk of alcl and allergan biocell textured implants pose a 16 times higher risk of alcl than lower surface area siltex textured implants by johnson johnson. They have been around for many years but have only just been approved by the fda in march 2012 textured implants only the polyurethane still to be approved as they are newer than the textured and haven t finished their study period as required by fda note they have been around since the 1970 s though and we re designed at first for reconstuctive surgery after. I have silimed textured rounds.
Every silimed implant has a brand and size embossed on the implant making it easy to identify at any time. I specifically asked for mentor implants but dr b 6 ignored my request and through 14 surgeries i got expired double sterilized silimed sientra implants. The gluteal implants have the perfect combination in the dimensions of base and projection that adjust harmonically to the anatomy of the region. A 5 year multi centre prospective study for the fda pre market approval for the silimed textured and smooth breast implants was published in october 2012 in the american prs journal.
This is described in the product information package which comes with all implants. Silimed is the only manufacturer with a serial number. Professor deva an academic and plastic surgeon believes the reason the biocell and silimed implants had a higher risk was because of their larger surface. Besides being the 1st non north american company to have its smooth and textured surface silicone gel mammary implants approved by fda we are also the first company in the world to identify each part with a serial number which allows the product traceability and.
The study demonstrates for the first time the reduction of common complications in breast surgery capsular contracture by using silimed textured surface implants verses smooth surface implants from 10. The differences between implant models can be dramatic. Textured implants as opposed to. For 40 years silimed has translated state of the art technology in quality of life for its clients all over the world.
I suffered from severe scar tissuing pushing my implants through my skin at least 3 times b 6 in my chest wall 3 times 14 disfiguring surgeries seroma and permanent numbness in both breast and my left implant fell through again in.