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FDA Approves Conditional Silicone Breast Implants
Author: Allen Jenks
On Wednesday 4/143/05, the FDA health advisors recommended removing the 13 year old ban on silione-gel breast implants. This move came about as Mentor Corp. persuaded the FDA that its newer silicone implants are much more safe and durable than older versions. The company may use these implants only under the following safety conditions set forth by the FDA.
- Prospective patients must sign a consent form acknowledging that they understand the risks of a silicone breast implant including the fact that they may break and require replacement or removal.
- Mentor may only sell silicone breast implants to board-certified plastic surgeons who complete a special hands-on training program to learn how to insert the implants in a way that minimizes the odds of it breaking.
- Mentor must create and maintain a registry to track the long term results patients have with the implants.
- Patients must be educated about the fact that if an implant breaks, the effect of the breakage generally does not cause immediate symptoms. Further they are advised to have an MRI scan after five years and every two years thereafter to check for breakage.
- Mentor must conduct a 10 year study to determine the percentage of breast implants that will break in that time.
- The study must be reviewed by an independent data monitor.
- The results of Mentor's breast implants will be reviewed by the FDA in five years to verify that the implants are performing as expected.
Silicone-gel breast implants began selling in 1962 and were banned in 1992 amid health fears. Research since then has shown that they do not cause serious diseases like cancer or lupus but that they can cause infection and scar tissue if they leak and are untreated.
Approximately 264,000 breast enlargements and 63,000 breast reconstructions were performed in the United States in 2003 - the vast majority using salt water filled implants that are sold without restriction. It is estimated that if the silicone breast implants return to the market, 200,000 women may have them installed within the first year.
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About the Author
Allen Jenks is a freelance writer that writes for The
Nutrition Guide at http://www.thenutritionguide.com and My Attorney Finder
http://www.myattorneyfinder.com.
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A Quick Note
From The Publisher...
If you like the article above, you may be
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| What s Up With Grilling Foods and HCA s |
| It’s summer and we all love to grill. Lots of us grill in the winter as well, that’s how much we love it. Now we hear cancer researchers are snooping around our love affair with grilling foods. If you are like most of us, when you hear the word cancer your ears perk up. So are grilling those beloved hamburgers and hotdogs a threat to your health? From what I understand, cancer researchers have found that grilling red meat, poultry, and fish causes the formation of carcinogenic compounds called HCA’s (heterocyclic amine). And, when fat from our grilling cuisine drips onto hot coals, another group of cancer-causing substances is formed. These are PAH’s (polycyclic aromatic hydrocarbon) which are deposited onto the food through the smoke and flames. The good news is, that researchers actually strongly disagree whether or not eating grilled foods actually pose a significant health risk. HCA’s have been linked to increased risk of cancers of the breast, colon, stomach, and... |
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Cancer, Breast Cancer Treatment News |
Indian-led study to revolutionize cancer treatment (New Kerala) By Gurmukh Singh, Toronto, Jan 6 : A team of Canadian researchers, led by Mick Bhatia of McMaster University near here, have found a way to identify malignant stem cells in cancer patients so that healthy cells are not destroyed during treatment. First-degree family history of prostate cancer does not affect some treatment outcomes (News-Medical-Net) In a first of its kind study, a first-degree family history of prostate cancer has no impact on the treatment outcomes of prostate cancer patients treated with brachytherapy (also called seed implants), and patients with this type of family history have clinical and pathologic characteristics similar to men with no family history at all, according to a January 1 study in the International ... New medical treatment helps Vernon man battle liver cancer (New Jersey Herald) A revolutionary new cancer treatment, only recently available, has succeeded in saving the life of Vernon resident John Dolan, and promises to save many more. Lowell Mayor C. Jeanne Shores resigns from City Council, focuses her efforts on cancer treatment (The Grand Rapids Press) LOWELL -- Mayor C. Jeanne Shores has resigned from the City Council to focus on her treatment for lung cancer, Lowell officials announced tonight. Press File PhotoFormer Lowell Mayor C. Jeanne Shores Shores, 72, had surgery last July to remove... |
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