Silicone Gel Breast Implants Overtake Salt Water Filled Ones

As silicone gel implants come back from the wilderness in the USA, experts believe their 15% market share of breast augmentations will gradually grow, to soon overtake saline implants.


Silicone gel breast implants have been around for over 40 years. They first came on the market in 1962. However, in the early 1990s concerns about their safety became such that they were banned in the USA. Concerns about a possible link between silicone gel breast implants and cancer and lupus were high, as were were concerns regarding the risk of ruptures. However, most studies have since failed to show a link between those implants and disease risk.


The breast enlargement market is huge in the USA. Approximately 300,000 women each year have their breasts enlarged, 58,000 had their breast(s) reconstructed last year.


The FDA has now approved silicone gel implants for breast enlargement for women aged 22 or over (the FDA said a woman's breast are not fully developed before that age). Allergan and Mentor Corp will now be able to sell silicone implants in the USA.


Dr. Daniel Schultz, Head of Medical Devices, FDA, says the agency has decided there is reasonable assurance that Allergan's and Mentor's silicone gel breast implants are safe and effective. He added that there is now adequate data to help women make informed decisions.


The FDA approved MemoryGel™(Mentor Corp) and INAMED® (Allergan Inc.).


The two companies will have to have to monitor patients for ten years and carefully check for leaks. They will also have to carry out a ten-year study on at least 40,000 women.


Women who opt for the gel may be assured they are reasonably safe. However, it is most likely they will, at some time, require surgery again, said the FDA.


Silicone gel breast implants are about twice the price of saline implants.


The FDA has not approved reconstructive implants for cancer patients - adjustable gel implants, used for 15 years, are now disallowed as well as anatomical gel implants.


Two Links from the FDA web site


-- Consumer Information on: Allergan Inamed® Silicone-Filled Breast Implants - P020056

-- Breast Implants Information - Approval of Allergan and Mentor Silicone Gel-Filled Breast Implants


Industry Links


-- Allergan's Breast Implant Web Site

-- Mentor Corporation Web Site

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