Mammary implants are being used since the 60’s. In 1963, Cronin and Gerow introduced a new model of prothesis, which consisted on a bag whose walls were made of a fine sheet or lamina of solid silicone and whose inner contents were variable amounts of gelatinous silicone. This prothesis avoided the big problems presented by liquid silicone and, at the same time, It could produce a perfectly natural shape and consistence at breasts. This model and its variations continues to be the most widely used today. There have been more than 5 millions silicone implants surgeries since the 60’s.
Silicone has many medical uses: Probes, catheters, pacemakers, puncture needles pointers, etc. Silicone is also used nowadays for correcting body outline, in the field of plastic surgery. The first patent related to silicone polymers is from 1958.
Silicone ( dimetilpolisolixane) can be produced as gel silicone, silicone oil and Elastomer silicone.. Oxygen and silica form a chemical linkage in silicones which is the same linkage that they form in stones and glass. Besides that, methylic groups join the silica atoms. Excepting amorphous silica as stabilizing and filling material, there is no other additive in silicone., and, specially, no softener additive.
Breasts augmentation or enlargement is one of the most practiced aesthetic surgeries, therefore, there are frequent improvements in the field of mammary implants.. Augmentation mammoplasty is the subject of many arguments and discussions, is a very polemic plastic surgery treatment because of future effects that implanted prothesis could have in patients.
Cooperation among patients, doctors, and the industry has produced great improvements and adaptations, at a constant rate. There is a huge scientific and technological knowledge in this field.
As a result of constant research, there is a new generation of prothesis in the market. These prothesis are made of cohesive gel, which guarantees safety to the patient in case of capsule rupture, and, also, brings better results than former prothesis in breast augmentation or enlargement. The gel that forms new mammary prothesis has been treated previously, to guarantee extreme safety in case of rupture. Actually, cohesive gel prothesis are not very different from the prothesis already available in the market (all consist on silicone). But new prothesis use as inner contents a gel that has new physical characteristics, due to its previous treatment. One of them is a new consistence that avoids the entrance of gel in the organism, in the rare case of a rupture of the inner capsule.Cohesive gel starts a new stage in breast augmentation surgeries.
There is a wide variety of implants, according to patients’ wishes and needs.
- Form: There can be round or anatomical prothesis.
- Filling: Prothesis can be inflated with physiologic saline solution or with Silicone gel, or Hidrogel.
- Surface: Prothesis surface can be smooth or textured.
- Purposes: There can be aesthetic or reconstructive purposes.
- Volume: Range of volume is from 60 cc to 500 cc, but any size of prothesis can be produced.
- Shape: Height and projection of implants can be low, high or extra high.
- Types and uses: There are mammary implants, as well as implants for the gluteal zone, calves of the legs, nose, chins, testicles, pectorals, penis. Also, malar and areolar implants. Implants can be produced according to any requirement that patients and doctors agree on.
Each implant has a wrapper and a filling; the wrapper contains the filling and avoids its leakage. Inflated ones also have a filling valve. The wrapper consists on a multilaminar layer that also has low permeability sub-layers, made of an elastomer (Silicone for medical uses, with exceptional physical and biocompatibility features). It has enough resistance to pressure, so that it guarantees an easy placement and a very natural feeling for the patient.
The inner contents consist of cohesive gel silicone, that, due to its cohesion, will not enter the organism in case of wrapper rupture.
Due to natural body reactions, a capsule is formed around strange things, even implants, that enter the body. This capsule could get hard and contract the implant.
This “capsular contracture” can deform the implant and alter the breast shape.
The possibility of this side effect is related, among other things, to implants surface. First produced implants had a smooth surface. In the mid 70’s, new implants were produced, whose surface consisted on polyurethane foam.
Finally, in the 80’s, surfaces were textured, trying to imitate the rugged material of polyurethane foam.
Without considering the different techniques that are currently used, polyurethane implants have showed very low rates of capsular contracture. (0-4%) Textured implants produce less capsular contracture than smooth implants.
Capsular contracture has fallen from 20% to less than 2% in the last 15 years, in breast augmentation procedures. Before surgery, a program of submuscular placement, textured implant, prophylactic antibiotics, infections filter, hematoma prevention, no cigarettes smoking, combined with an after surgery program of preventing early hematomas, mobilization of the implant, infections prevention, and therapeutic agents, can lower the risk of capsular contracture. (Becker, 1999)
Some years ago, a new material was introduced in the market: Soya oil. It was used as a filling for Trilucent prothesis, It is an unstable compound and degrades into other chemical compounds. In 1999, Trilucent prothesis were removed from the market, after many complications were detected, such as inflammation, swelling, and general indisposition, related to the prothesis.
In the 90’s, there was a long debate and people were very concerned about silicone implants, after some reports that warned general public about the danger of silicone implants. The American Society for Aesthetic Plastic Surgery (ASAPS) carried out a research, in 2003, studying more than 5000 cases. 87% of women didn’t need an extra surgery due to complications, 13% of women requested an extra surgery, but for a very different reason: They wanted to change breast size, or improve breast position. In some cases, they wanted a new implant that could be got in the market.
Scientific studies in the last five years have not found any connection between mammary prothesis and breast cancer or autoimmune diseases. A study, published in 2001, considered 13500 women with implants, showing no links between implants and breast cancer, late detection of cancer, or mortality increase.
An article published by Breast Cancer Research magazine in 2004 indicated that women with gel silicone implants had similar, if not less, complications or deaths that women with other types of implants.
An experts panel met in 2003 and voted in favor of approving again silicone implants in the U.S.A. The FDA decided to wait for more studies and facts about silicone implants safety. A new experts meeting carried out in April, 2005, analyzed scientific researches about safety of gel silicone implants. This panel voted in favor of one manufacturer (Mentor), because this company ‘s product has the lowest rate of rupture.
The New England Journal of Medicine may settle this controversy in an article published this year, that shows that silicone implants do not increase collagen diseases. The article also concludes that, as far as public health is concerned, there is no danger in silicone implants, this procedure is completely safe, and the removal of these implants from the market has no impact at all in reducing collagen or autoimmune diseases.
Patients must ask themselves: Why do I want a breast enlargement? If you want to satisfy your partner or get a better job or please other people by getting a breast enlargement, you are wrong. You must get a breast enlargement only because you want to look better, to see yourself better, for your self image, as a gift for yourself.
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