Suitable to biotypes of every woman searching of an aesthetic, harmonic result, Silimed offers a wide variety of models of silicone gel mammary implants. The options vary according to the type of material, dimensions, texture, volume, projection, and so on. It is also possible to choose from a polyurethane foam coated surface, textured surface or a smooth surface.
TECHNOLOGY TESTED AND APPROVED FOR 45 YEARS
Breast implants coated with polyurethane foam have been successfully used since 1968 – long before implants with textured surface. Its technology is not new but is still considered to be the most advanced. It has been safely tried and approved for 45 years, benefiting doctors and patients in many parts of the world.
The implants with textured surface were introduced in the market in 1984 (16 years later) to imitate the polyurethane surface. However, the final results were not satisfactory in relation to the rates of capsular contracture. Implants with polyurethane foam coating present contracture rates which are substantially lower than those presented by textured surface implants.
“Based on the analysis of our data, we can come to the conclusion that the rate of capsular contracture, obtained after having carried out all types of breast surgeries, is dramatically lower when polyurethane foam coated implants are used, than with
the use of smooth or textured implants. ” (HANDEL N. Long-term safety and efficacy of polyurethane foam-covered breast implants. Aesthetic Surg. J., 26: 265, 2006)
ASSURANCE FROM THE WORLD’S MOST EXPERIENCED COMPANY IN PURE POLYURETHANE
Silimed has operated in the market for 35 years, following the highest standards of safety and quality, and marketing its products in more than 70 countries. It is the world’s most experienced company in the manufacture of silicone mammary implants coated with polyurethane foam (Pure Polyurethane), being continuously manufactured since 1989. Silimed is a pioneer in the industry that has developed its own technology, contributing to permanent innovations in the field of plastic breast surgery. Throughout its 25 years in the market, Silimed has already manufactured and marketed around 1 million Pure Polyurethane implants on all five continents.
Scientific evidence has been published on the safety and efficacy of mammary implants coated with polyurethane foam in breast augmentation and reconstruction surgeries 1,6,7,10,11.
- Natural look and soft to the touch
Scientific publications provide evidence of the safety and efficacy of breast augmentation and reconstruction surgeries using Pure Polyurethane mammary implants. These implants are more likely to look natural, since they present the lowest rate of capsular contracture, which makes them softer to the touch. Another advantage is the so-called “non-palpable” border. The seams of Pure Polyurethane mammary implants are located in the interior part and are therefore not apparent in patients with thin skin9.
“The Pure Polyurethane mammary implants provide a natural aesthetic effect, soft to the touch, which is progressive and highly satisfactory.” (MIRÓ AL. Mammary prostheses coated with polyurethane: evaluation of 14 years of experience. Rev. Bras. Cir. Plást., 24 (3): 296, 2009)
- Lower risk of capsular contracture
The main cause of reoperations in breast augmentation surgeries is capsular contracture2. Over the last 40 years, several published articles have presented a reduction of capsular contracture rates with the use of Pure Polyurethane implants when compared to those provided by other surfaces. Studies conducted by Pitanguy, Vásquez and Vásquez and Pellón presented a rate of capsular contracture of only 1%6. No studies have been published showing opposite results.
- Neither rotation nor displacement of the implant
The second leading cause of reoperations in breast augmentation surgeries is the rotation and displacement of the implant3. The use of Pure Polyurethane reduces this problem. The stable link of the polyurethane foam with the capsule formed by human tissue reduces the risk of rotation and displacement of the implant. Several studies confirm this claim6, which is the so-called Velcro effect. The Pure Polyurethane implant allows a close interaction between implants and the tissue surrounding them, inducing physiological conditions that deviate fibroblasts from the pocket and thus reducing the synthesis of collagen, which is the precursor of the fibrotic capsule
- Multi-oriented contraction
The polyurethane foam stimulates an inflammatory response, similar to the one caused by a foreign body, with intense vascularization and migration of macrophage cells. Its three-dimensional structure (3D matrix) does not favor the formation of a fibrous capsule, favoring instead the formation of multi-planar fibrils of linear collagen. The formation of microcapsules around irregularities in the polyurethane structure causes the contraction force to be multi-oriented instead of having only one orientation. Having multiple vectors, these forces tend to cancel each other, thus reducing capsular contracture.7
- Velcro effect
The 3D matrix of collagen intertwining inside the polyurethane foam causes a Velcro-type adhesion, which prevents rotation or displacement of the implant. The polyurethane foam coating has a high coefficient of friction, making the implants resistant to rotation and displacement immediately after insertion, even before capsule formation.
“Silimed has developed the next generation of silicone mammary implants, coated with polyurethane foam, vulcanizing the foam to the implant’s surface and thus preventing double capsule and rotation of the implant.”(VÁZQUEZ G & Pellón).8
Legend 1 – smooth surface capsule: fibroblasts aligned.
Legend 2 – textured surface capsule.
Legend 3 – capsule with polyurethane foam coated surface: microencapsulation of fibroblasts.
Clinical studies have also investigated the relation between polyurethane foam and the incidence of cancer. In 1995, the FDA stated that the risk of contracting cancer throughout the life for women with a pair of silicone implants coated with polyurethane foam is of approximately 1 in 1,000,000. According to the controlled study from Hester et al4, “the calculation of the risk during life, which is approximately one in one million, was calculated based on concentrations of 2.4 free of TDA in relation to the implantation time”. Handel5 conducted a controlled, blinded study, under the FDA’s supervision, and no 2.4 free of TDA were found in the blood of the patient.
The Brazilian Society of Plastic Surgery also takes a stand in this regard: “According to the analysis of this commission, which was based on the material that was brought to the study, there are currently no new data known to this commission concerning the potential risks involving breast implants coated with polyurethane and a possible association with breast cancer or neoplastic pathologies of any other nature.” (Brazilian Society of Plastic Surgery, May 2013).
Studies conducted by Pompei et al11 suggest: Breast reconstruction using polyurethane implants for patients who have undergone radiotherapy is an acceptable solution regarding the risk of complications and capsular contracture. It is also concluded that “silicone mammary implants coated with polyurethane foam” seem to be a valuable tool for the prevention of severe capsular contracture, as has already been demonstrated in cosmetic surgery.
- It is not difficult to use, only different
The mammary implants coated with polyurethane foam are not difficult to use. Its use is only different. Some surgeons are not familiar with the procedure, but as soon as they incorporate the changes, they stop using the old techniques due to the excellent results achieved. The choice of the surgical plan, the site of incision, the size and volume profile are the same as used for implants with other surfaces. However, there are minor changes in the surgical technique9. The surgeon will be able to start using these implants and improve the results of surgeries after just a few adjustments in the technique.
THE MAIN ADJUSTMENTS IN THE SURGICAL TECHNIQUE:
- The surgeon shall place the polyurethane foam coated implant in the desired final position, since they will remain at the site where they are placed. Therefore, a placement that is too high must be avoided. It is suggested that the patient is placed in the sitting position during the intra-operative period, before closing the incision. The implants shall then be adjusted in such a way that the inferior border of the implant is at the desirable height postoperatively.
- It is not necessary to make larger incisions than usual. Silimed provides a plastic insertion sleeve, through which the implants can be inserted.
- The implants present a green guideline that is used as a position indicator. The green spot is the highest point of projection on the implant. On the rear of the implant, soft palpable spots provide aid to the doctor to correctly position the implant.
- Since the capsule is integrated inside the foam, a generous pocket needs to be made to ensure that there is no deformation or folds. The friction of the surface of the foam will keep the implant in place until the foam adheres to the tissue, forming the capsule. No cases of rotation have been reported involving implants coated with polyurethane foam.
The main needs of physicians and patients are the following: safety of the implant, reduced complications and satisfactory aesthetic results. For this reason, Silimed Pure Polyurethane silicone mammary implants are the best option existing on the market.
1 HANDEL N. Long-term safety and efficacy of polyurethane foam-covered breast implants. Aesthetic Surgery Journal, 26: 265, 2006.
3 Safety of Silicone Breast Implant. Institute of Medicine (US) Committee on the Safety of Silicone Breast Implants; Bondurant S, Ernster V, Herdman R, editors. Washington (DC): National Academies Press (US); 1999.
4 HESTER et al. Measurement of 2, 4-Toluenediamine in Urine and Serum Samples from Women with Même or Replicon Breast Implants. Plastic & Reconstructive Surgery: Volume 100(5). October 1997 pp 1291-1298.
5 HANDEL N. Long-term safety and efficacy of polyurethane foam-covered breast implants. Aesthetic Surgery Journal, 26: 265, 2006.
6 PITANGUY I, Salgado F, Radwanski HN, Stersa RM. Estágio atual dos implantes mamários. Plastiko’s – Revista da Sociedade Brasileira de Cirurgia Plástica, 81: 291, 1991; VÁZQUEZ G. A ten-year experience using polyurethane-covered breast implants. Aesthetic Plastic Surgery, 23: 189, 1999; VÁZQUEZ G & Pellón A. Polyurethane-coasted silicone gel breast implants used for 18 years. Aesthetic Plastic Surgery, 31: 330, 2007.
7 MIRÓ et al. Próteses mamárias revestidas com poliuretano: avaliação de 14 anos de experiência. Plastiko’s – Revista da Sociedade Brasileira de Cirurgia Plástica, 24 (3): 296, 2009. VÁZQUEZ G & Pellón A. Polyurethane-coated silicone gel breast implants used for 18 years. Aesthetic Plastic Surgery, 31: 330, 2007.
8 VÁZQUEZ G & Pellón A. Polyurethane-coated silicone gel breast implants used for 18 years. Aesthetic Plastic Surgery, 31: 330, 2007.
9 VÁZQUEZ G. A ten-year experience using polyurethane-covered breast implants. Aesthetic Plastic Surgery, 23: 189, 1999.
10 MIRÓ et al. Próteses mamárias revestidas com poliuretano: avaliação de 14 anos de experiência. Plastiko’s – Revista da Sociedade Brasileira de Cirurgia Plástica, 24 (3): 296, 2009.
11 POMPEI et al. Breast reconstruction with polyurethane implants: preliminary report. Eur J Plat Surg., 2011.
Advantages, safety and efficacy of True Texture mammary implants.
SILIMED – TRADITION AND EXPERIENCE IN THE MANUFACTURE OF TEXTURED IMPLANTS
Silimed started the manufacture of textured mammary implants with three different textures in the 1990s. In 2000, the company developed its own method of texturization, which resulted in a structure of peaks and valleys that creates pores, reducing the incidence of capsular contracture1. In March 2012, Silimed became the first manufacturer in the world to have anatomical silicone mammary implants approved by the FDA for the North American market.
- Lower rate of capsular contracture
Clinical studies indicate the effectiveness of Silimed True Texture implants in reducing the phenomenon of capsular contracture. Stevens et al.2 reported their experience in the use of 708 implants filled with cohesive silicone gel, textured surface, from Silimed. The implants used were reference 20621, with an average volume of 394 ml (ranging from 135 to 1000 ml). The authors claim that these types of implants are safe, presenting a profile of complications similar to those of other models of silicone gel implants, with a lower rate of capsular contracture and a lower incidence of wrinkling when compared to the silicone gel implants of the fourth generation (and also according to information from other studies published on the implants of the fifth generation).
The initial study (Clinical Study conducted in the USA for Sientra USA Food and Drug Administration – Approved Silimed Mammary Implants with high performance silicone gel, round and anatomical) presents1,2,3:
- 6% of baker grade III or IV capsular contracture for primary breast augmentation and 9% for primary breast reconstruction.
- 0.6% of seroma for primary breast augmentation, compared to 0.9% and 1.3% of other manufacturers.
- Rotation zero in five years.
1 STEVENS WG et al Five-Year follow up data from the U.S. Clinical Trial for Sientra’s U.S. Food and Drug Admnistration-Approved Silimed brand round and shapped implants with high-strength silicone gel. Plastic and Reconstructive Surgery, vol. 130 Nº 5, november 2012.
2 STEVENS WG, Hirsch EM, Tenenbaum MJ, Acevedo M., A prospective study of 708 form-stable silicone gel breast implants. Aesthetic Surgery Journal, 30 (5): 693, 2010.
SAFETY AND EFFICACY
Silimed uses a high-performance cohesive silicone gel (HSC) in the manufacture of its textured mammary implants. This gel has been specially developed with a polymeric structure, resulting in fewer occurrences of fracture and perfect cohesiveness. HSC is soft enough to simulate the feel of natural tissue of the breasts, and firm enough to maintain the shape of the implant. HSC high-performance cohesive gel is supplied by Applied Silicone Corporation, a company based in the United States, whose products are designed to meet ISO 10993 as well as FDA’s biocompatibility requirements.
- Resistance without fracturing the gel.
- Softness without compromising the form of retention.
Compendiums are supported by the Material Master Records, which are submitted to the FDA.
TRUE TEXTURE – BARRIER TECHNOLOGY WITH LOW-BLEED SHELL
Silimed’s texturing method results in the formation of a structure with peaks and valleys which creates pores to stimulate tissue growth. This technology avoids the use of sodium chloride, sugar, stamping or pressure methods. The shells manufactured by Silimed present several barrier layers, resulting in “low-bleed” implants.
Silimed mammary implants present a guideline that acts as a position indicator, along with a spot at the maximum projection point of the implant. Palpable soft spots, located at the rear of the implant, provide aid to the doctor for the correct positioning of the implants.