On July 28, 2005, the FDA issued a letter of approval to Mentor Corp ending a thirteen-year ban on silicone-gel breast implants. This step occurred when Mentor Corp persuaded the FDA that the new silicone implant was less harmful and more durable than the old version. The company will use this implant only under the following safety requirements approved by the FDA.
- Prospective patients need to sign a consent form acknowledging that they are aware of the risk of silicone breast implants including the fact that they can be broken down and require replacement or removal.
- Mentors are only allowed to sell silicone breast implants to a board-certified plastic surgeon who completes a successful practical training program to learn how to insert the implant in a way that minimizes the risk of rupture.
- Mentors must generate and maintain enrollment to track long-term implant patients.
- Patients should be educated about the fact that if the implant is damaged, the damage usually does not cause any immediate symptoms. Further it is advisable to have an MRI after 5 years and 2 years thereafter to check for damage.
- Mentors must conduct a ten-year study to determine the percentage of breast implants that will rupture at that time.
- This study should be reviewed by an independent committee.
- The results of the Mentor breast implant program will be reviewed by the FDA within 5 years to confirm that the implant is being implemented as expected.
According to the American Association of Aesthetic Plastic Surgery, 334,052 breast enlargements were made in the United States in 2004 - the majority of which use implants filled with saline that are sold without restrictions. Consumer surveys predict that if silicone breast implants return to market, 200,000 women will install them in the first year.
Silicone-gel breast implants were first sold in 1962 and banned in 1992 amid fears of health. Previous studies have shown no statistical link between silicone breast implants and cancer or auto-immune diseases such as lupus. Some women will swear that their health has deteriorated since they installed their implants, but this is anecdotal evidence. When researchers compared large groups of women with implants to the same group without them, there was no difference between the two groups in the number of women with cancer or autoimmune disease.
Excess formation of scar tissue due to foreign body reaction is common.
If it is localized, it can cause attractiveness and rippling effect on the appearance of the implant. If the scar tissue completely encloses the implant, the condition is called capsule contraction.
These scars can bind the implant into an abnormal round shape, making it appear that the woman has baseball stuck under the skin on her chest. This condition is more common with thin-walled silicone implants, although it occurs at a lower level with the implant also. The implants placed behind the chest muscles have a lower incidence of this problem.
Surgeons can sometimes break down the scar tissue manually (which is not recommended, as it can break the implant and invalidate the manufacturer's warranty), but follow-up surgery is often required.
Accolate asthma drugs have been used with some success in preventing and even reverse capsular contraction, although months of treatment may be necessary.
Other possible complications include seroma (serous fluid group), hematoma (blood), synmastia (breast unified in center), exits (implant slide too far into chest)
doubles (outline of implants do not touch natural breast folds), deflation (implant break), tissue necrosis (local tissue death) and infection.
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