INDIANAPOLIS, IN, January 05, 2012
/24-7PressRelease/ -- In 2006, the Food & Drug Administration approved two new models of silicone implants: one model was made by Mentor and the other by Allergan. This approval by the FDA proved controversial as many critics claimed there wasn't enough evidence of
silicone implants being safe for the long term.
To study how the implants held up over long-term, the FDA required both Mentor and Allergan to perform a variety of follow-up studies--some studies won't even end until 2016. The study involved 40,000 participants for each model, totaling 80,000 in all.
Some studies included an effectiveness study of women who've already received the
implants like focus groups, patient surveys, and a large post-approval study with a group of new women.
In addition to patient studies, other studies considered the surgeons' decisions regarding the surgery of 50 randomly selected physicians.
However, Allergan has only a 60% follow-up rate while only one in four patients who have received Mentor implants were followed after two years.
Dr. Joseph Fata of
Renaissance Plastic Surgery offers an explanation as to why women are so unlikely to follow up, "As a plastic surgeon, I would agree that it is difficult to get patients to return for long-term follow up after all procedures, not just breast implants, especially if they are satisfied with their result. They all have busy lives and often don't want to take the time to hear what they already know: Everything is going well."
The FDA presented collected data showing that after 8-10 years of having the surgery, women are quite happy with their decision and results. The FDA also noticed that, even though it is highly recommended that women who have breast implants to get an MRI three years after the surgery and every two years thereafter to screen for any ruptures, MRI screenings are also low. The reason? Most health insurance companies won't cover the costs of getting an MRI if there isn't an apparent problem and most women are unwilling or unable to pay for the cost out-of-pocket. According to Dr. Fata, there is another issue: "There is a small chance that an MRI scan will give a false positive, in which the scan shows a leak but at surgery the implant looks fine, resulting in unnecessary surgery."
Though the follow-up rates are low for this study, the FDA has never removed a product from the market merely for the reason that a company has not been able to receive the appropriate number of willing participants.
About
Dr. Fata performs a wide range of cosmetic surgery procedures in his Indianapolis office and his surgery center in nearby Carmel, Indiana, including breast augmentation (breast enlargement), breast lift, and breast reduction, and he uses both silicone gel breast implants and saline breast implants. He also performs liposuction, tummy tuck (or Abdominoplasty), cosmetic eyelid surgery, rhinoplasty (surgery of the nose), and facelifts. For more information, call (317) 575-9152 or visit the Renaissance Plastic Surgery Center at 10293 N. Meridian Ste. #200, Indianapolis, IN 46290.
Website:
http://www.breastsurgeryindianapolis.com/---
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