Breast Implant Safety

Breast Implants in Sydney – Safety

Is it safe to get breast implants in Sydney?

The short version is ‘Yes, it is safe – but like all implants and procedures, there are some risks.’ If you are considering breast implants in Sydney, then you should get as much information as possible to make your decision. To fully understand the fuss about breast implants, read on …

The first breast implants

Breast implants have been available since Dow Corning began producing the Cronin & Gerow implant in 1962. Implants have ‘evolved’ through several generations of improvements. In 2010, we are currently using 5th generation implants with enhanced cohesive silicone gel, textured silicone surface, and a diverse array of anatomical and round shapes and sizes.

In 1988, the US FDA requested implant manufacturers to provide data to prove the safety of silicone filled implants. By 1992, the FDA ruled that silicone gel filled implants were not necessarily unsafe, but that they required more data to substantiate safety & efficacy than the manufacturers had supplied. This ruling essentially took silicone gel breast implants off the US market, except under approved clinical trials, leaving only the saline filled implant available to the general public.

American lawsuits against breast implants

Also during this time, there had been a few court decisions that had found against the implant manufacturers in cases in which patients had filed that their silicone implants were responsible for a number of conditions. This lead to a snow-balling effect and culminated in a class action of almost half a million women against Dow Corning. The company filed for bankruptcy and withdrew from the market, leaving Mentor and Allergan* as the remaining implant manufacturers in the US Market.

Second generation implants did have their problems. These implants were made from a thin silicone outer with a thin silicone gel filling. When these implants leaked, the silicone gel was like a caramel that was difficult to remove.

Silicone breast implants ruled safe in the US

By the late 1990s, there had been several very large independent scientific studies that showed there is no increased risk of development of connective tissue disorders in women with breast implants.

In June 2001, The Australian TGA approved the use of silicone gel filled implants for use in Australia for cosmetic and reconstructive purposes. Currently, 99% of breast implants in Sydney and throughout Australia are silicone implants. The manufacturers filed for approval with the US FDA by the end of 2001, and this was granted in November of 2006.

What about polyurethane breast implants?

Polyurethane implants are reported to have several advantages over ‘standard’ silicone shell implants. The furry outer shell reduces the amount of movement possible by the implant (at the cost of a slightly longer incision), and the body grows into this shell quite deeply, further integrating and stabilising the implant over time. There is reported to be reduced incidence of capsular contracture over the long term. Personal communication between surgeons reveals that this is not always the case, but they still remain an option used to reduce that risk.

However, they have had several problems over the last two decades. First was the assertion in the early 1990s that a breakdown product of polyurethane foam may be carcinogenic. This was based on a study that showed that mice that were fed very high doses of this carcinogen had increased risk of breast cancer. The FDA eventually decided that women with polyurethane coated implants were not at increased risk of development of cancer. More recently (31st March 2010), the French Health department ordered a French manufacturer of polyurethane implants to recall their product due to an increased incidence of ruptures in their product.

The TGA has performed safety tests and declared that the implants supplied in the Australian market do meet the international safety guidelines. When you get breast implants in Sydney, polyurethane implants are available to you, but Dr Sandercoe very rarely recommends them.

Are breast implants linked to lymphoma?

The latest safety concern about breast implants was a possible link to lymphoma in patients with breast implants. After a few patients were identified during 2009, the Australian Society of Plastic Surgeons informed the TGA proactively. The TGA replied to ASPS on 29th May 2010, stating that “assigning significance to the findings is premature at this time.” In early February 2011, the US FDA also reported that there is a small increase in risk of ALCL, but at the moment “FDA approved breast implants are safe and effective when used as labelled.”

What are the choices for breast implants in Sydney?

Current manufacturers of breast implants in Australia (2010)

•    Mentor

•    Allergan

•    Silimed

•    Eurosilicone

•    Nagor

*    Manufacturer names have been changed to the current (up to date) versions, as some of the manufacturers have had several name changes over the past few decades.

Wikipedia Article on Breast Implants

Patient Education Library