Silicone back on market after FDA approval

By Louise Prance

- Last updated on GMT

Related tags Fda

US Food and Drug Administration (FDA) officials have this month
approved the sales of silicone breast implants for the first time
in 14 years. Revelations that have led to widespread scepticism as
to whether it is to soon for silicone to be back on the cosmetic

Following the four-year review of an extensive amount of data from clinical trials, the FDA has deemed the marketing of silicone breast implants from two companies, Mentor and Allergan, to be safe and effective for women over the age of 22 years old.

Daniel Schultz, MD for the centre for devices and radiological health, FDA, said in a statement: 'The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labelling and will enable women and their physicians to make informed decisions'.

Silicone implants were removed from the public forum in the US in 1992 due to concerns that silicone leakages in the body were linked to connective tissue diseases and cancer. A safer alternative, Saline, was the only other option for women, however, complaints were made that they did not feel or look as natural as silicone, resulting in a bid for silicone to be reintroduced.

Following the recent four-year study of the implants, the FDA has deemed them to be safe for public use. However, each manufacturer is bound by regulation to conduct extensive post approval studies in order to gage whether they are indeed causing damage to consumers.

The study will consist of monitoring over 10,000 women who have received the breast implants to assess whether they are experiencing any adverse effects. The companies are also required to 'answer important questions that can only be answered once a product is in broader use'.

However, there are worries from media insiders that the FDA research is not extensive enough to validate the re-emergence of these products. The FDA claim that nothing it approves carries definite proof that it is absolutely safe for people.

Despite a report by the Institute of Medicine concluding that there is no convincing evidence that silicone implants are linked to cancer or connective tissue disease, smaller companies suggest that there is.

Many women also suggested that the implants caused breast pain, hardening of the area around the implant, change in nipple sensations, implant rupture and the need for additional surgery. Complaints that many people fear will still be present in silicon implants despite the recent FDA approval.

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