November 30, 2007

Boob Jobs for Men

It appears that the American Society of Plastic Surgeons (ASPS) is now hawking breast work for men. For men with excess breast tissue, or mild gynecomastia, pectoral etching is an excellent alternative to pectoral implants, according to a study in December’s Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS). Involving targeted liposuction, it leaves virtually undetectable scars, has no potential rejection issues and offers permanent results. For a more balanced look, men often have both abdominal and pectoral etching, which I think is just another way of saying lipo on both boobs and tummy.

Well, what a relief! All this time I’ve had the nagging feeling that the plastic surgery industry preys on women’s insecurities, but actually, it is an equal-opportunity predator.

Men’s cosmetic surgery is slowly climbing. In 2006, 1.1 million men underwent plastic surgery, up 8 percent since 2000, according to ASPS statistics. More than 400 pectoral implant procedures were performed on men last year, up 99 percent since 2005.

In regard to pectoral etching, Henry Mentz, MD, ASPS Member Surgeon and co-author of the above study, says in this article, “Many men simply don’t know the procedure is even out there let alone that it’s a safe, effective option for them.” The plastic surgery industry has of course been spectacularly successful in making sure ALL women know that breast implants are an option for each and every one of us. I wonder how many of the same tried-and-true methods it used there will translate across genders. It’ll be interesting to see how the male population responds.

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November 26, 2007

Mentor Spent $180,000 Fighting FDA Scientific Fairness Act for Women

Filed under: Breast Implants, FDA, News, Women's Health — Sybil @ 10:22 pm

In accordance with a 1995 federal law that requires lobbyists to disclose activities that could influence members of the executive and legislative branches, Mentor has filed disclosure documents with the Senate public records office for 2007. This year, according to today’s Pacific Coast Business Times, the breast-implant maker spent about $180,000 on lobbying, most of it against the FDA Scientific Fairness for Women Act, sponsored by long-time women’s health advocate Rep. Rosa DeLauro [D-CT].

The bill proposes to amend the Federal Food, Drug, and Cosmetic Act to:

§ Elevate the Office of Women’s Health within the FDA so that the office reports directly to the Commissioner, instead of being buried two levels down from the Commissioner;

§ Rescind approval of silicone breast implants until manufacturers can conclusively demonstrate their safety over the life of an implant; and

§ Require FDA to convene a workshop to review and evaluate current scientific data on the use of emergency contraception by young women under the age of 18.

The bill is now in committee and not likely to ever emerge to be debated by the House. Why? Because the voices of women’s health advocates supporting the bill have been completely drowned out by the shower of Mentor’s hundreds of thousands of dollars.

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November 20, 2007

New Law Gives FDA More Control

Filed under: FDA, News — Pam Noonan-Saraceni @ 11:54 am

I just read an article that was posted on medtrackalert.com, written by David Stanley, a community pharmacist for 15 years. The article points out that the Food and Drug Administration has responsibility for reviewing the safety of medications, but what will surprise most people is that until this year, there was never a requirement that a drug ever be studied again once it was approved for the market. This meant that the FDA had no way to address the safety concerns of medications or medical devices except to pull the product off the market.

Congress recently passed the Food and Drug Administration Amendments Act of 2007. The new law gives the FDA the ability to order manufacturers to do post-approval clinical trials and to penalize them if they don’t follow through.

The FDA now has the authority to order changes in drug labeling so that doctors and the public will be informed sooner of potential risk factors.

The act will also establish an Internet database with information from all clinical trials that will be administered by the National Institute of Health. This database will be open to both researchers and the general public.

I have personal concern with the NIH data base. It is a fact that there are a zillion clinical trials that have been funded by manufacturers. The outcomes are often biased in favor of the manufacturers’ products. My fear is that this information might give the public a false sense of security when it comes to particular drugs and medical devices.

That being said, hopefully this new act will be a step towards getting the FDA back on track to protecting the consumer. SAFETY FIRST, before they put the FDA stamp of approval on a product!

November 19, 2007

To What Lengths Will They Go to Change the Way Women Look?

Filed under: Beauty, FDA, Women's Health — Sybil @ 8:56 pm

I just saw this article about an eyelash lengthener that is actually a medication to treat eye disease!

And why is the lifeless, ineffectual FDA all in a twitter over this as opposed to other, more health-threatening products?

Last Friday, the lifeless, ineffectual FDA sent agents to a warehouse and seized thousands of tubes of Age Intervention Eyelash, which the FDA called an “unapproved and misbranded drug.” The agency, according to the article, said it hadn’t received any reports of patient injuries, but warned the product might be potentially harmful because it conains bimatoprost, the chemical in the prescription drug to treat eye disease.

Where was the FDA when they received thousands and thousands of reports about injuries from implants? They didn’t listen, suggesting that women with implants were just complainers. Then they sat on their hands, did nothing, then approved the product! Here we have a case of a possibly dangerous product with no negative reports and the FDA is all over them like a swarm of bees.

I just don’t get it. But, I do get this: There is no way that I will use any product that has been approved for the treatment of disease and then turned into a cosmetic product. I’m not signing on for products developed as the result of an unexpected side-effect.

I will go to no length to achieve longer eyelashes. I hope you won’t either.

November 17, 2007

FDA’s New Proposals to Deal With Conflicts of Interest Are Bittersweet for Breast Implant Safety Advocates

Filed under: Breast Implants, FDA, News — Sybil @ 12:59 am

This story on the AP wire shows some progress at the FDA. Sadly, it is too late for the issue of breast implants. Many members of the FDA panel that approved implants clearly had conflicts of interest, including one who took money from the manufacturers to make a cd extolling the virtues of breast implants. Sometimes doing the right thing is better late than never, but with the approval of implants anything the FDA does about the disclosure of conflicts of interest is at this point too little and too late.

These are the proposed changes:

1) The experts will have to disclose any financial ties to the industry under review.

2) Experts on the advisory committees will have to fill out a form disclosing the potential conflicts and explaining why they should still be able to advise the agency.

3) If the FDA agrees to a waiver, the disclosure form will be posted on the FDA’s Web site, typically at least 15 days before the committee meets.

A 2006 study found that more than one-fourth of the experts relied on for advice on drugs, including whether to approve new pharmaceuticals, has a financial conflict. The FDA says a ban on all outside reviewers with potential conflicts is impractical because so many scientists whose expertise the government relies on have ties to industries under FDA regulation. While the FDA is not required to follow the recommendations of such outside advisers, usually does.

The proposed rules are open for public comment for 60 days before the FDA makes a decision whether to revise or adopt them.

November 15, 2007

Women Over 50 NOT Choosing Plastic Surgery!

Filed under: Beauty, Body Image, Culture and Society — Pam Noonan-Saraceni @ 3:27 pm

I recently read a quote in the November issue of More magazine. “Almost 3/4 of cosmetic surgery is done on patients UNDER 50 years old.” This was a finding taken from the American Society for Aesthetic Plastic Surgery and comprehensive surveys conducted by Trend Sight Group.

This statement took me by surprise, as when I think cosmetic surgery, I automatically think “appearance age reduction.” To me, that is for mature women!

Of course, it is statistics such as this that drives the manufactures’ advertising campaign dollars. It is no wonder that all the anti-aging products, skin care and diet programs are all being advertised using lovely young women and men under 30-years old.

What has driven our society of beautiful young men and women to this point of such low self esteem? There are so many out there who are not happy unless they have the PERFECT, nose, eyes, teeth, breasts and waist size.

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November 13, 2007

Donda West’s Death Shines Light on Risks of Plastic Surgery

Filed under: Culture and Society, News, Plastic Surgery — Mary @ 7:20 pm

Last week, Donda West, rap superstar Kanye West’s mother, entered an operating room to get a breast reduction and tummy tuck. By Saturday night, she was dead, apparently from complications from the surgery. She was only 58.

You can find details here.

Donda West had everything going for her: a distinguished past career as a college English department chair, a fabulously successful and devoted son, wealth. She had a rewarding second career as the chief executive of West Brands LLC, the parent company of her son’s business enterprises, and as chairwoman of the Kanye West Foundation. She had a beautiful home and an exciting, glamorous life as Kanye loved to show her off at parties, awards ceremonies and other glittering celebrity events. But she wanted to look a little better and maybe feel a little better about herself, and she lost it all.

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November 12, 2007

OC Register’s Special Cosmetic Medicine Section: It’s Not Just About “Feeling Better About Yourself”

Filed under: Breast Implants, Media, Plastic Surgery, Women's Health — Sybil @ 8:22 am

The Orange County Register last week included a special section about cosmetic medicine, with a focus on breast implants. I applaud the OC Register and the lead writer, Innovation Columnist Colin Stewart, for addressing the safety issue, which these days most media coverage totally ignores. If the OC Register ever decides to do another cosmetic medicine section, however, I hope they come to me for ideas. I have a few suggestions on how they could have done it better:

I. The article, “Weighing safety vs. aesthetics of implants,” should appear above the one that compare saline and silicone implants, which helps women “shop” for implants. Its placement implies that safety is a lesser concern than consumer product choice.

II. The safety article, itself, answers three questions:

Do breast implants cause disease?
How long will breast implants last?
What if I have the implants removed?

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November 11, 2007

Our Stories…There Are So Many

Filed under: Breast Implants, Breasts, Culture and Society, Media, Plastic Surgery, Women — jeena @ 10:17 pm

The information and dialogue on this site is a refreshing and major step in the right direction, and I want to commend all of you for your dedication and courage. Thank you for this wonderful opportunity and freedom to comment on these important issues!

Explantation.Com was born out of a desire to help women who need permanent breast implant removal. Rose and I remain overwhelmed by the magnitude of this need. We knew there were others, but had no clue how many women were out there! Our support forum and stories are only a small representation of what we have witnessed behind the scenes. “Our Stories” have been written and contributed by the most intelligent and amazing people we have ever met. These courageous women have shared their photos, time and personal experiences, and the kind, caring way they have come forward to help us is truly humbling. Without their fearless honesty and trust, there would be no Explantation.Com. These unique and beautiful individuals have risked their privacy and reputations with absolutely no compensation or selfish agenda. They simply want to make certain no other woman will be alone on this confusing implant journey. Thankfully, the majority of our stories have had positive outcomes. We are proof that with proper medical care and expertise, it is possible to successfully remove unwanted implants.

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November 8, 2007

Writing Effective “Letters to the Editor”

Filed under: Media — Sybil @ 8:50 am

For those who want to write effective “Letters to the Editor” of a newspaper, please follow the suggestions listed below. They actually came from an email from The Washington Post but I think the rules apply to all newspapers.

1. Letters should be fewer than 200 words and exclusive to The Washington Post.

2. The letter may not have been submitted to or published by any other
media or Internet outlet. This includes comments or feedback posted to Web
sites. If you have posted similar comments to a Web site, your letter will
not be considered.

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