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Jonathan Tobin: Defending the Right to a Jewish State

Heather Hale: Compliment your kids without giving them big heads

Megan Shauri: 10 ways you are ruining your own happiness

Carolyn Bigda: 8 Best Dividend Stocks for 2015

Kiplinger's Personal Finance editors: 7 Things You Didn't Know About Paying Off Student Loans

Samantha Olson: The Crucial Mistake 55% Of Parents Are Making At Their Baby's Bedtime

Densie Well, Ph.D., R.D. Open your eyes to yellow vegetables

The Kosher Gourmet by Megan Gordon With its colorful cache of purples and oranges and reds, COLLARD GREEN SLAW is a marvelous mood booster --- not to mention just downright delish
April 18, 2014

Rabbi Yonason Goldson: Clarifying one of the greatest philosophical conundrums in theology

Caroline B. Glick: The disappearance of US will

Megan Wallgren: 10 things I've learned from my teenagers

Lizette Borreli: Green Tea Boosts Brain Power, May Help Treat Dementia

John Ericson: Trying hard to be 'positive' but never succeeding? Blame Your Brain

The Kosher Gourmet by Julie Rothman Almondy, flourless torta del re (Italian king's cake), has royal roots, is simple to make, . . . but devour it because it's simply delicious

April 14, 2014

Rabbi Dr Naftali Brawer: Passover frees us from the tyranny of time

Greg Crosby: Passing Over Religion

Eric Schulzke: First degree: How America really recovered from a murder epidemic

Georgia Lee: When love is not enough: Teaching your kids about the realities of adult relationships

Cameron Huddleston: Freebies for Your Lawn and Garden

Gordon Pape: How you can tell if your financial adviser is setting you up for potential ruin

Dana Dovey: Up to 500,000 people die each year from hepatitis C-related liver disease. New Treatment Has Over 90% Success Rate

Justin Caba: Eating Watermelon Can Help Control High Blood Pressure

The Kosher Gourmet by Joshua E. London and Lou Marmon Don't dare pass over these Pesach picks for Manischewitz!

April 11, 2014

Rabbi Hillel Goldberg: Silence is much more than golden

Caroline B. Glick: Forgetting freedom at Passover

Susan Swann: How to value a child for who he is, not just what he does

Cameron Huddleston: 7 Financial Tasks You Should Tackle Right Now

Sandra Block and Lisa Gerstner: How to Profit From Your Passion

Susan Scutti: A Simple Blood Test Might Soon Diagnose Cancer

Chris Weller: Have A Slow Metabolism? Let Science Speed It Up For You

The Kosher Gourmet by Diane Rossen Worthington Whitefish Terrine: A French take on gefilte fish

April 9, 2014

Jonathan Tobin: Why Did Kerry Lie About Israeli Blame?

Samuel G. Freedman: A resolution 70 years later for a father's unsettling legacy of ashes from Dachau

Jessica Ivins: A resolution 70 years later for a father's unsettling legacy of ashes from Dachau

Kim Giles: Asking for help is not weakness

Kathy Kristof and Barbara Hoch Marcus: 7 Great Growth Israeli Stocks

Matthew Mientka: How Beans, Peas, And Chickpeas Cleanse Bad Cholesterol and Lowers Risk of Heart Disease

Sabrina Bachai: 5 At-Home Treatments For Headaches

The Kosher Gourmet by Daniel Neman Have yourself a matzo ball: The secrets bubby never told you and recipes she could have never imagined

April 8, 2014

Lori Nawyn: At Your Wit's End and Back: Finding Peace

Susan B. Garland and Rachel L. Sheedy: Strategies Married Couples Can Use to Boost Benefits

David Muhlbaum: Smart Tax Deductions Non-Itemizers Can Claim

Jill Weisenberger, M.S., R.D.N., C.D.E : Before You Lose Your Mental Edge

Dana Dovey: Coffee Drinkers Rejoice! Your Cup Of Joe Can Prevent Death From Liver Disease

Chris Weller: Electric 'Thinking Cap' Puts Your Brain Power Into High Gear

The Kosher Gourmet by Marlene Parrish A gift of hazelnuts keeps giving --- for a variety of nutty recipes: Entree, side, soup, dessert

April 4, 2014

Rabbi David Gutterman: The Word for Nothing Means Everything

Charles Krauthammer: Kerry's folly, Chapter 3

Amy Peterson: A life of love: How to build lasting relationships with your children

John Ericson: Older Women: Save Your Heart, Prevent Stroke Don't Drink Diet

John Ericson: Why 50 million Americans will still have spring allergies after taking meds

Cameron Huddleston: Best and Worst Buys of April 2014

Stacy Rapacon: Great Mutual Funds for Young Investors

Sarah Boesveld: Teacher keeps promise to mail thousands of former students letters written by their past selves

The Kosher Gourmet by Sharon Thompson Anyone can make a salad, you say. But can they make a great salad? (SECRETS, TESTED TECHNIQUES + 4 RECIPES, INCLUDING DRESSINGS)

April 2, 2014

Paul Greenberg: Death and joy in the spring

Dan Barry: Should South Carolina Jews be forced to maintain this chimney built by Germans serving the Nazis?

Mayra Bitsko: Save me! An alien took over my child's personality

Frank Clayton: Get happy: 20 scientifically proven happiness activities

Susan Scutti: It's Genetic! Obesity and the 'Carb Breakdown' Gene

Lecia Bushak: Why Hand Sanitizer May Actually Harm Your Health

Stacy Rapacon: Great Funds You Can Own for $500 or Less

Cameron Huddleston: 7 Ways to Save on Home Decor

The Kosher Gourmet by Steve Petusevsky Exploring ingredients as edible-stuffed containers (TWO RECIPES + TIPS & TECHINQUES)

Jewish World Review August 5, 2005 / 29 Tammuz, 5765

High risk with low benefit — FDA should not reapprove silicone breast implants

By Drs. Michael A. Glueck & Robert J. Cihak

The Medicine Men
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http://www.JewishWorldReview.com | What on Earth is the FDA thinking? Haven't they ever heard the old adage, Fool me once and it's your fault but fool me twice and it's my fault.

Following the recommendations of an advisory panel, the Food and Drug Administration last Thursday, July 28, told one device company that its implants can be approved under certain conditions. So, following a 13-year hiatus, silicone-filled breast implants are another step closer to returning to the market.

But why? With all the time, energy, aggravation, money lost, lawsuits, destruction of companies, and pain and suffering associated with the initial product why do we want to chance harming more women and give the lawyers another shot to make even more billions. The trial lawyers must be slobbering down their pinstriped blue and charcoal custom suits.

There is a medical dictum that asserts you must always consider the risks vs. the benefits of any procedure. Silicone breast implants are high risk and low benefit!

Breast implants are not a life or death necessity and there are saline alternatives. At best cosmetic breast implants are a plastic surgical procedure but not in the classical sense of curing a serious congenital or developmental disorder or restoring form and function to a damaged part of the body from injury or radical surgery. An exception to this is breast implants following mastectomy for cancer which certainly are medically indicated and warranted. At worst breast implants are a vanity procedure performed too often on too many women by too many alleged plastic surgeons. Approximately 250,000 breast implants and 250,000 reduction mammoplasties are done per year.

Silicone-gel implants bounced on the market in 1962, before the FDA required proof that all medical devices be safe and effective.

They were banned in 1992 because of health concerns. The implants have been for the most part exonerated of junk science concerns that they might cause serious or chronic illnesses, such as cancer, lupus or collagen diseases.

Although exonerated of blame we have yet to see any of the patients, plaintiffs or trial lawyers return any of the hundreds of millions of dollars they reaped from the lawsuits. To assume there will be no more problems and lawsuits is like thinking Al Queda won't attack America again.

Aside from the risk of breakage, these implants can cause infection and painful scar tissue. And they will again!

The FDA committee voted 7-2 on April 13 to recommend allowing them back on the market under certain conditions. Women must understand that the devices might break silently inside their bodies, and the FDA recommended that women get regular MRI exams to check for such breaks. The FDA also stated that only specially trained plastic surgeons should be allowed to perform implant insertions, and they required new studies to prove how long implants last.

To assume these recommendations will be followed faithfully is a giant leap of faith. Also, who will decide who is qualified to do the surgery? There are many surgical specialties that perform breast implants with many surgeons who call themselves plastic surgeons. The surgical turf wars will take years to battle and litigate. And some women will always value shop for the cheapest surgeon regardless of warnings!

The FDA's confirmation of its intent to approve the implants occurred even though the Senate Health, Education, Labor and Pensions Committee is investigating the advisory committee's recommendation from four months ago.

A band of female senators led by Sens. Dianne Feinstein, D-Calif., and Olympia Snowe, R-Maine, urged the FDA last Thursday to consider women's safety before the agency makes a final decision.

Women who want the product's return say silicone-gel implants feel and appear more natural than the saltwater-filled implants currently sold without restriction. But other women told the advisory panel stories about gel oozing out of their breasts and body and years of pain and other symptoms.

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Diana Zuckerman, president of the National Research Center for Women & Families, who has argued that the devices are not proven safe, called the action "shocking."

It seems to us that the FDA is acting irresponsibly and that reapproval will only lead to repeat problems.

If the FDA wants to revisit prior decisions it deems poor or in error perhaps it should re-evaluate its recent bans on non-steroidal anti-inflammatory agents (NSAIDS) such as Celebrex, Vioxx, Bextra and Mobic. With 50 million patients in chronic pain from arthritis and defenerative disc disease that would seem far more reasonable.

Health concerns for women should override a vanity implant for which there is a safe saline substitute. The FDA should make better usage of it's time and our money.

Editor's Note: Michael Arnold Glueck penned this week's commentary.

Every weekday JewishWorldReview.com publishes what many in in the media and Washington consider "must-reading". Sign up for the daily JWR update. It's free. Just click here.

Michael Arnold Glueck, M.D., is a multiple award winning writer who comments on medical-legal issues. Robert J. Cihak, M.D., is a Discovery Institute Senior Fellow and a past president of the Association of American Physicians and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists. Comment by clicking here.

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