Breast Implants

Excerpt

Breast implants have evolved since the crisis of the 1990s and are 1 of the most frequently performed aesthetic procedures. We now have cohesive gel implants, highly cohesive gel (ie, gummy bear) implants, saline implants, and structured saline implants with different surfaces and shapes from which to choose. Recently structured saline implants were also approved and are now available. Enhancing breasts goes back to 1895 when Czerny attempted fat transfers. This has been followed by paraffin injections and the use of glass balls and ivory. In the 1950s, commercially manufactured sponge implants were introduced, made from various chemicals. This was plagued by contractures, infection, and erosion (see Image. Capsular Contracture). Due to the complications, enhancement surgery was not popular until the 1960s when commercially manufactured silicone gel implants were introduced.

Silicone use in augmentation began in the 1940s as its use became more widespread following World War II, and it was later used in medical devices in the 1950s. There are suggestions that silicone was injected into women's breasts in WWII and often migrated away from where it was placed, leading to many complications, including pain and loss of the breast. In 1962, Dr Thomas Cronin designed a shell to contain the silicone gel and, with the Dow Corning Corporation in 1963, produced the breast implant as we know it today. Saline implants were available as well once shells were used for containing the fill, but saline implants were known to ripple more and have a higher failure rate (estimated more than 75%). Implants have gone through a myriad of styles and design changes, starting with external patches and polyurethane-coated shells, to softer gel fills, to newer designed shells to diminish diffusion of the silicone oil through the shell, all in response to the problems that were encountered with the patients. Gel also was made more cohesive, where the gel tended to stick together rather than break off into particulates that could disseminate into adjacent tissues.

In 1992, a moratorium on gel implants was issued by the United States (US) Food and Drug Administration (FDA); saline implants were the only implants available in the US as they were thought to be safer. There were textured anatomic, textured round, and smooth round implants available that could be filled with a range of volumes that allowed for the correction of mild asymmetries if appreciated. Smooth round implants became the most popular implant of choice once it was determined from radiographic studies that round implants assumed the same shape as shaped implants when viewed from the side in an upright position.

In the mid-2000s, cohesive gel implants were introduced and allowed by the FDA. Varying levels of cohesiveness were also being experimented with to where we now have highly cohesive, form-stable implants in the textured anatomic and smooth round designs, cohesive gel in textured or smooth round implants, and round saline implants in textured or smooth surfaces. Just recently, the structured (bi-lumen) Ideal implant has been introduced and is available for use. All companies offer comparable warranties for rupture and capsular contracture.

Upon return of gel implants to the market, the FDA arbitrarily limited gel implants for use only in women older than 22 unless used in the reconstruction. Gel implants can be used "off label" in patients younger than 22, but surgeons must caution their patients that their warranties may not be valid or honored by the manufacturer. Hopefully, the FDA will eventually lift this age restriction.