Saturday, April 23, 2011
Addition by subtraction - Pro tennis player's Simona Halep's breast reduction
Back in 2009 I wrote a post titled "Pro tennis player Simona Halep's cups no longer runneth over." (yes I was making bad puns then too) which highlighted WTA tennis player, Simona Halep, a promising Romanian junior tennis champion who's progress was being hampered by her very large breasts. Later that year she underwent a breast reduction surgery from a DD to a C cup bra size and has made steady progress with her career and is currently ranked #65 on the world tour. Today, Ms. Halep reached the final of a WTA event in Morocco and will play for her 1st WTA tour level title tomorrow.
BRAVO! As shown below, it's easy to see how Ms. Halep's mobility should have been greatly improved by her surgery. It's hard to argue with results.
PREOPERATIVE in 2009
POST OPERATIVE in April 2011
Rob
Friday, April 22, 2011
Putting a stake thru the routine MRI screening of silicone gel breast implants
When the USFDA lifted a nearly 2 decade moratorium on the use of silicone gel breast implants for cosmetic surgery indications in 2006, there were two puzzling things added to the product labeling.
1. The use of silicone gel implants should be limited to women >22 years olds.
2. That women should undergo routine MRI screening of their implants for rupture every 2-3 years.
The first instruction re. an age restriction on women 18-22 is patently absurd and is a nod to the "unique" political history of silicone breast implants in the USA. One more thing we thank lawyers for!
The second suggestion re. MRI was always puzzling, particularly as the rupture rate is so low for modern implants through the first decade where the FDA would otherwise be having patients undergo 5 screening MRI's (at year 3,5,7, & 9). This intuitively is throwing money down the drain as the yield is low and violates what most people consider appropriate in a screening test.
New data and review of the literature from the University of Michagan suggest that while MRI is fairly accurate in detecting implant-related problems, it is 14 times more likely to detect them in women with implant-related symptoms than in women without symptoms.It has been concluded that because most women in the studies had symptoms, the true accuracy of MRI for detecting implant-related problems in asymptomatic women is probably much,much lower and calls into question the whole idea about routine screening for rupture. Beyond the issue of accuracy, the authors comment that screening tests are generally performed to detect diseases with serious consequences-whereas the health risks associated with ruptured silicone implants, if any, are still unknown. To date, there is no single systemic disease or illness clearly attributable silicone gel implants despite them being the most studied medical device in the history of medicine.
Hopefully this will lead to the updating of the current FDA labeling for these devices that causes some confusion for patients and adds significant extra expense for no benefit.
Rob
1. The use of silicone gel implants should be limited to women >22 years olds.
2. That women should undergo routine MRI screening of their implants for rupture every 2-3 years.
The first instruction re. an age restriction on women 18-22 is patently absurd and is a nod to the "unique" political history of silicone breast implants in the USA. One more thing we thank lawyers for!
The second suggestion re. MRI was always puzzling, particularly as the rupture rate is so low for modern implants through the first decade where the FDA would otherwise be having patients undergo 5 screening MRI's (at year 3,5,7, & 9). This intuitively is throwing money down the drain as the yield is low and violates what most people consider appropriate in a screening test.
New data and review of the literature from the University of Michagan suggest that while MRI is fairly accurate in detecting implant-related problems, it is 14 times more likely to detect them in women with implant-related symptoms than in women without symptoms.It has been concluded that because most women in the studies had symptoms, the true accuracy of MRI for detecting implant-related problems in asymptomatic women is probably much,much lower and calls into question the whole idea about routine screening for rupture. Beyond the issue of accuracy, the authors comment that screening tests are generally performed to detect diseases with serious consequences-whereas the health risks associated with ruptured silicone implants, if any, are still unknown. To date, there is no single systemic disease or illness clearly attributable silicone gel implants despite them being the most studied medical device in the history of medicine.
Hopefully this will lead to the updating of the current FDA labeling for these devices that causes some confusion for patients and adds significant extra expense for no benefit.
Rob
Labels:
breast implant,
fda,
MRI,
silicone breast impant
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