Silicone Breast Implants Revived by FDA

On July 28 2005, the FDA issued a letter of approval to Mentor Corp ending the the thirteen year old ban on silicone-gel breast implants. This move came about as Mentor Corp. persuaded the FDA that its newer silicone implants are less dangerous and more durable than older versions. The company will employ these implants only under the following strict safety conditions approved by the FDA.

- Prospective patients must sign a consent form acknowledging that they realise the risks of a silicone breast implant including the fact that they could break and need replacement or removal.

- Mentor is only allowed to sell silicone breast implants to board-certified plastic surgeons who complete a successful practical training program to learn how to insert these implants in a way that minimizes the odds of breakage.

- Mentor must produce and maintain a registry to track the implant patients long term results.

- Patients must be educated about the fact that if an implant breaks, the effect of the breakage typically doesn't cause immediate symptoms. Further it is advised to have an MRI after 5 years and 2 years thereafter to check for breakage.

- Mentor must conduct a ten year study to determine the percentage of breast implants that will break in that time.

- The study must be reviewed by an independent committee.

- The results of Mentor's breast implant program will be reviewed by the FDA in 5 years to verify that the implants are performing as expected.

According to the American Society for Aesthetic Plastic Surgery, 334,052 breast augmentations were performed in the United States in 2004 - the vast majority employing salt water filled implants that are sold without restriction. Consumer surveys predict that if the silicone breast implants return to the market, 200,000 women will have them installed in the 1st year.

Silicone-gel breast implants began selling in 1962 and were banned in 1992 amid health fears. Research since then has shown no statistical correlation between silicone breast implants and cancer or auto-immune disease such as lupus. Some women will swear that their health deteriorated from the moment they had their implants placed, but this is anecdotal evidence. When researchers compare a large group of women with implants to an equally large group without them, no difference between the two groups is found in the number of women with cancer or autoimmune disease.

Formation of excess scar tissue due to a foreign-body reaction is common. If it is localized, it can cause traction and rippling effects in the appearance of the implant. If the scar tissue completely encircles the implant the condition is called capsular contraction. These scars can bind the implant into an unnatural round shape, so that it appears the woman has a baseball stuck under the skin on her chest. This condition is more common with smooth-walled silicone implants, though it occurs to a lesser extent with saline implants as well. Implants placed behind the chest muscle have a much lower incidence of this problem. Surgeons can sometimes break the scar tissue manually (which is not recommeded, as it can break the implant and void the manufacturer's warranty) , but often follow-up surgery is needed.

The asthma drug Accolate has been used with some success to prevent and even reverse capsular contraction, though months of treatment may be required.

Other possible complications include seroma (a collection of serous fluid), hematoma (blood), synmastia (breasts that appear to be fused in the center), bottoming out (implant slides too far down the chest), double-fold ( the implant's outline does not corresspond to the natural breast crease), deflation (the implant breaks), tissue necrosis (localized death of tissue) and infection.

Frank Vanderlugt

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