Headwear Etc Blog

dateline December 3, 2006) Format for Printing

After a 14-year ban, the U.S. Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are manufactured by Allergan Corporation (formerly Inamed Corporation) and Mentor Corporation.

“FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products,” said Daniel Schultz, MD, FDA Director for the Center for Devices and Radiological Health, in a news release. “The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions.”

The FDA’s decision to approve the use of silicone gel-filled breast implants was based on a thorough review of studies by Allegan and Mentor Corporations, a review of studies by independent scientific bodies, and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. The FDA also performed inspections of each company’s manufacturing facilities to determine that they comply with FDA’s Good Manufacturing Practices. According to the FDA, the majority of women in these studies reported being satisfied with their implants.

In 1992, the FDA imposed a ban on the general use of silicone gel-filled breast implants in the United States. The banned stemmed from concerns about the safety of silicone implants after manufacturing defects and implant misuse led to silicone leakage and rupturing in many patients. When silicone gel is free in breast tissue, it may move to nearby tissues or to the lymph nodes. Some physicians attributed silicone leakage to immune-related disorders and other sicknesses. Many women who experienced silicone leakage reported:

breast pain
fatigue
myalgias (muscle pain)
arthralgias (joint pain)
hair loss
memory loss

There was much controversy surrounding the FDA’s ban on silicone breast implants. Many medical experts doubted silicone implants caused any significant medical disease. However, radiologists do worry about the difficulty in detecting breast cancer in breast with implants (saline or silicone). Click here for below on breast imaging after reconstruction for more information.

“The silicone breast implant is one of the most extensively studied medical devices,” said Schultz. “We now have a good understanding of what complications can occur and at what rates. We also know that women who get these devices will probably need to have additional breast implant surgery at least once. This is valuable information for women who may be considering these products.”

The FDA will continue to monitor silicone gel-filled breast implants by requiring Allergan and Mentor Corporations to conduct a large post-approval study following about 40,000 women for 10 years after receiving the implants. The FDA will also require that full information about the risks and benefits of the implants be included in the package and patient labeling. Other requirements of the approval include: a focus group study of the patient labeling; further laboratory studies to study the types of implant failures; and following each implant in the event, for example, that health professionals and patients need to be notified of updated product information.

GOOD NUTRITION POSSIBLE DURING HOLIDAYS
COLLEGE STATION - The holiday season has arrived, and with it has come all that delicious, high-fat foods which can make this time of year the easiest time to overindulge. “The holiday season is the time when you should enjoy food,” she said. “You’re going to be socializing with friends and no doubt there will be food present.”

And believe it or not, some traditional holiday foods have quite a bit of nutritional value. Of course, Anding added, many of them come with some dietary trade-offs.

For example, a one-cup serving of eggnog contains one-third of the suggested daily allowance for calcium, which is good for those who worry about calcium intake. However, it also contains 342 calories, with a hefty chunk of them from fat. And that’s non-alcoholic eggnog; add another 100 calories or so if alcohol is added.

What about holiday desserts? Even there, some choices are better than others when it comes to nutrition. According to “Bowes & Church’s Food Values of Portions Commonly Used, 17th edition,” by Jean A.T. Pennington, one-eighth of a nine-inch pumpkin pie containing 316 calories and 14 grams of fat would be a better choice than the same-sized piece of apple pie, with 411 calories and 19 grams of fat, or pecan pie, with 503 calories and 27 grams of fat. Anding did note most of the fat in the pecan pie is not the type that clogs arteries.

Aside from being lower in calories and fat than the other two kinds of pies, the pumpkin pie also supplies more than 100 percent of the suggested daily amount of vitamin A, Anding said, which makes it even more of a wise choice.

“The American Dietetic Association’s Complete Food and Nutrition Guide” also suggests some holiday substitutions that can help keep diets healthier during this time of year. Its leaner menu suggests substituting skinless roast turkey, wild rice pilaf, broccoli with lemon juice and whole-grain roll for the higher-calorie and fat menu of skinless roast duck breast, stuffing, broccoli with hollandaise sauce and crescent roll.

Holiday dieters can get some encouragement from “The New England Journal of Medicine,” which released “A Prospective Study of Holiday Weight Gain” in its March 23 issue. The study found that, in spite of popular belief, the average holiday weight gain is only about a pound, not the five to 10 pounds most people think it is.

But the downside to that is: The weight gained during the winter holiday season tends to stay on, especially if healthful eating habits and regular physical activity are not reestablished into the post-holiday routine.

However, Anding advised, trying to lose weight during the holiday season isn’t a good idea. “Go for weight maintenance,” she said. “Otherwise you are setting yourself up for failure.”

There are no such things as “good” foods and “bad” foods, she said. “Eat your favorite foods you like to eat during the holiday season,” but use common sense when you do. “As long as it’s done in moderation, any food can be included in a holiday feast.”

Anding offers some tips to keep that holiday dining indulgence from becoming over-indulgence:

- If your holiday plans include attending a party, snack before you go to take the edge off your appetite before you get there.

- When at a party socializing with friends, move away from the buffet table to eliminate the tendency to dip into the food while standing and talking.

- Use smaller plates; take smaller portions.

- Don’t forget to count calories from alcohol. If drinking alcoholic-containing beverages, do so in moderation and choose those made with diet or club soda instead of juice or full-calorie soda.

- If making multiple trips to the buffet table, take vegetables, fruits, low-fat rice and pasta and lean meats during the first trip, then go for smaller portions of other foods during the second.

- Keep exercise as part of the daily routine. Not only is exercise a vital part of a plan for healthy living, but it’s a great stress reliever too. And there’s no denying that the holidays are stressful.

- Most important, listen to your stomach and eat until you are no longer hungry, not until you are full.

Above all, Anding said, don’t feel guilty about enjoying some of your favorite holiday foods, especially if they are a once-a year treat and part of a family tradition. And keeping a healthy diet and getting regular physical activity is a process, she said, and if you overindulge at one meal, compensate the next. It’s the process that’s important, not what is eaten at any one meal.

And enjoy the season.

Workouts Help Ward Off Cancer’s Return
Thursday, November 30, 2006; 12:00 AM

THURSDAY, Nov. 30 (HealthDay News) — For cancer survivors, exercising and maintaining a healthy weight are important factors in preventing malignancy’s return, at least for some forms of the disease.

That’s the conclusion of an American Cancer Society report that updates nutrition and physical activity recommendations for cancer survivors during and after treatment.

In Depth

Among the points contained in the report:

For some kinds of cancer, just 1 to 3 hours a week of exercise can lower the risk of cancer recurrence and death, as well as death from all causes. Exercise has also been shown to improve fitness, fatigue, and several other quality of life aspects in cancer survivors.While a vegetarian diet can help health in some ways, there’s no direct evidence that this kind of diet can prevent cancer recurrence. Survivors who eat a vegetarian diet should ensure that they’re getting an adequate intake of nutrients.A standard multivitamin and mineral supplement in amounts equivalent to 100 percent of the Daily Value can help cancer survivors meet their nutrient needs when it’s difficult for them to eat a healthy diet. However, some supplements — such as those with high levels of folic acid or antioxidants — may be harmful during cancer treatment.Food safety is especially important for cancer survivors, particularly during treatment that involves immunosuppression.Alcohol can affect the risk for new primary cancers in certain areas of the body.