IPL and Laser Damage

I came across this messageboard today and feel it is well worth visiting by anyone interested in any cosmetic procedure.

Also worth reading: What is IPL and Laser Damage Support All About?

The people who truly have the power to put an end to the devastating harm caused by the cosmetic surgery industry are out there.. You. You can "just say no" to subjecting your normal, healthy body to the trauma of unnecessary cosmetic procedures! What? Sounds too simple? If you can't say no, then at least realize that you are gambling with more than your looks. You are gambling with your health and your life.

FDA Warns About Lipodissolve Product Claims

It's a tempting premise: Get a series of drug injections and see pockets of fat on your body go away for good.

But the Food and Drug Administration (FDA) is alerting consumers about false and misleading claims being made about products used in lipodissolve, and about other misbranding of these products.

Recipients of lipodissolve get a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. The process is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.

“We are concerned that these companies are misleading consumers,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal.”

The drugs most regularly used in the lipodissolve injection regimen are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively). Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.

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What Consumers Should Know

FDA is alerting consumers that

• it has not evaluated or approved products for use in lipodissolve
• it is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination
• the safety of these substances, when used alone or in combination, is unknown
• it is not aware of clinical studies to support medical uses of lipodissolve

In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure. These side effects include

• permanent scarring
• skin deformation
• deep, painful knots under the skin in areas where the lipodissolve treatments were injected

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FDA Actions

On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products. (Cyber letters are letters sent to companies whose U.S. online sales of products may be illegal.)

The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve

• are safe and effective
• have an outstanding safety record
• are superior to other fat-loss procedures, including liposuction

Additionally some of the letters indicate that the companies have made claims that lipodissolve can be used to treat certain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities.

The U.S. companies receiving warning letters in regard to lipodissolve products are

• Monarch Med Spa, King of Prussia, Pa.
• Spa 35, Boise, Idaho
  
• Medical Cosmetic Enhancements, Chevy Chase, Md.
• Innovative Directions in Health, Edina, Minn.
• PURE Med Spa, Boca Raton, Fla.
• All About You Med Spa, Madison, Ind.

FDA is requesting a written response from these U.S. companies within 15 business days of receipt of the letters stating how they will correct these violations and prevent similar violations in the future. These firms were told that failure to promptly correct the violations may result in legal action.

The Brazilian firm getting a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com. FDA will notify regulatory authorities in Brazil of this action. The agency has issued an import alert against the zipmed.net and mesoone.com entities to prevent the importation and distribution of unapproved lipodissolve drug products into the United States. Importing and distributing unapproved drug products is a violation of the Federal Food, Drug, and Cosmetic Act.

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How to Report Side Effects

Consumers and health care professionals may report serious side effects with the use of lipodissolve products to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

• online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm⁴
• by regular mail: Use postage-paid, pre-addressed FDA form 3500⁵
• by Fax: (800) FDA-0178
• by phone: (800) FDA-1088

This article appears on FDA's Consumer Updates page⁶, which features the latest on all FDA-regulated products.

Date Posted: April 7, 2010

Botox death lawsuit filed in Indiana over death of young girl

The parents of a 10-year old girl with cerebral palsy who died in 2008 have filed a lawsuit against Allergan, Inc. and the doctors who treated their daughter because they used Botox in an attempt to treat her conditions. The doctors at the Riley Hospital for Children in Indiana used the controversial cosmetic drug to appease the girl’s muscle spasms, despite the fact that Botox has never been approved for such use by the U.S. Food and Drug Administration.

The parents allege that the doctors and drug makers failed to warn them or inform them of the possible life-threatening side effects that are associated with Botox. The drug contains a small amount of toxin that is widely recognized as a cause of Botulism, a paralytic condition that considerably restricts muscle use. The daughter passed away within days of her Botox treatment, as the toxin spread and inhibited her breathing.

The FDA placed a Black Box warning on Botox in 2009, after the administration had received numerous reports of complications stemming from using the drug for treating cerebral palsy. In February 2008, the FDA issued a warning about the possibility of complications, despite the fact that the drug has only ever been approved for use in cosmetic treatments such as wrinkle reduction and smoothing of the skin, as well as alleviating crossed eyes, combating heavy sweating, and appeasing involuntary muscle contractions and eye blinking.

At least a dozen lawsuits have been filed against Allergan and various medical professionals and other parties, as people are alleging that the drug has been falsely pushed as a treatment for cerebral palsy and other similar illnesses. The parents of the 10-year old girl had to first present their claim to the Indiana Department of Insurance, which will then allow a panel of medical professionals to determine if their case can move forward to state or federal court. Allergan recently won a lawsuit filed in California alleging that the company was negligent in the death of a 7-year old girl, who was also being treated for cerebral palsy with Botox.

Suit ties death of woman to face lift

By Jonathan Saltzman
Boston Globe Staff / March 4, 2010

Donna Ames, a recently divorced mother of three, was depressed and wanted to look younger. So the 49-year-old woman went to the Waltham office of Lifestyle Lift, a national cosmetic surgery company that markets its face lift as a way to “transform your life.’’

Instead of making her wrinkles vanish, the procedure killed her, Ames’s family and lawyers say in a lawsuit filed yesterday.

Minutes after a doctor administered local anesthesia on July 10 last year, Ames’s body jerked violently, and the oxygen in her blood plunged, according to a summary written by her family’s attorneys. By the time the clinic called an ambulance, the Lowell woman was brain dead.

“My mom wanted to make her life better, and they sort of took it away,’’ Evan Ames, her 18-year-old son and ad ministrator of her estate, said yesterday of Lifestyle Lift. “I’m very mad.’’

The Middlesex Superior Court suit is not the first time the company, based in Troy, Mich., has been accused of wrongdoing.

Last year, Lifestyle Lift, which says it operates more than 40 centers nationwide and advertises its procedure as safer and less invasive than traditional face lifts, agreed to pay $300,000 in penalties and costs to New York State for publishing bogus consumer reviews on websites.

Lifestyle Lift said in a statement yesterday that it was “very sorry about the sudden and unexpected passing of Ms. Ames.’’ The company has not seen the suit but said its face lift “is known as one of the safest facial procedures available because it uses a local numbing medication rather than general anesthesia.’’

The statement also said that Ames did not disclose a history of seizures or allergies to anesthesia and that staff called 911 when she became ill.

The defendants named in the suit are Lifestyle Lift and two physicians, Dr. Sanchayeeta Mitra and Dr. James C. Alex. The center, which has moved to Burlington, referred inquires to the company’s headquarters.

Evan Ames, a freshman at the University of Massachusetts Dartmouth, said his mother had talked about getting a face lift for some time, although he had no idea she had gone to Lifestyle Lift until after she died.

His mother, he said, had struggled for years with bipolar disorder and had been depressed since getting divorced from his father about two years ago. She had owned a maternity clothing store in Burlington for seven years, he said, but was not working at the time she had the surgery.

“She was trying to turn her life around and get another start,’’ said Ames.

Donna Ames paid $4,700 for the elective surgery, considerably less than for traditional face lifts, which cost more than $10,000 on average, according to the Ames family’s lawyer, Andrew C. Meyer Jr. of Boston. She went to the Waltham center with a friend, who planned to drive her home after a procedure that was supposed to take only about an hour.

Ames’s vital signs, including her blood pressure and oxygen levels, were stable when she entered the center, Meyer said. But minutes after she received anesthetic injections, she had a seizure and her blood pressure and oxygen levels fell, which Meyer said is a potential side effect from anesthesia.

Ames was not hooked up to any continuous-monitoring equipment, and no anesthesiologist was present, according to Meyer, so the medical staff did not know immediately how little oxygen she was getting. Forty-eight minutes after Ames received her first injection, the staff called for an ambulance; she was deprived of oxygen for far too long, Meyer said.

It was not immediately clear yesterday whether continuous-monitoring equipment and an anesthesiologist were required by law. But Meyer said a medical specialist hired by the family contends that they should have been present in case of potentially dangerous side effects from the anesthesia.

Ames was taken by ambulance to Mount Auburn Hospital in Cambridge, where her heart stopped twice and she was diagnosed as brain dead, Meyer said. Her family took her off life support a week later.

“She goes in [the Waltham center] with a friend, expecting to be out in an hour or so, and was brain dead in half an hour,’’ Meyer said.

Lifestyle Lift says on its website that it has treated more than 100,000 people since 2001 and that “the results have been life-changing.’’ The procedure, it says, is less expensive than traditional face lifts and avoids “the anesthesia risk and physical trauma’’ of the conventional process, which employs general anesthesia.

Unlike traditional face lifts, Lifestyle Lift is not a full face lift or neck lift but creates muscle tension using sutures instead of patients’ skin, Meyer said.

The Lifestyle Lift has been featured on numerous television programs, including “The Montel Williams Show,’’ and has been advertised widely in infomercials. But the company agreed to pay a $300,000 settlement last year after New York’s attorney general, Andrew Cuomo, determined it had engaged in “astroturf marketing,’’ *creating bogus grass-roots buzz by having employees fabricate online testimonials.

“I need you to devote the day to doing more postings on the Web as a satisfied client,’’ employees were told in one internal e-mail, according to Cuomo’s office.

After the settlement, Lifestyle Lift said it had changed its informational material to reflect actual patients’ comments.

Jonathan Saltzman can be reached at jsaltzman@globe.com.

My note:
* This is exactly what some plastic surgeons do who maintain an online presence. I know of one Indianapolis surgeon who pays people to boost his online persona. Consequently, he has also engaged in the most brutal, unethical legal take-down of a patient's website.

What Happens If Your Mother Has Plastic Surgery?

by Delia Ephron
Posted: February 3, 2010 01:13 PM
The Huffington Post

I haven't been watching many reality shows lately because of the crying. There is simply too much of it. Last season on Project Runway, Christopher cried because he was sure that he was the only person in the world who would design a dress inspired by a rock (something I am sure he is wrong about). I have no idea how much crying there is on The Hills, since I was never a fan, but it did catch my attention in People magazine that Heidi Montag, star of the show, cried after she had ten plastic surgery procedures in one day. Heidi, I know from a quick Google search, is 23, although since her plastic surgery she looks 33. Which is actually something to cry about.

I have been interested in and done research on this subject spun slightly different: What happens if your mother (not your favorite reality star) has plastic surgery? This is the subject of my new novel for teenagers, The Girl with the Mermaid Hair.

If, as a teenager, you spend hours in front of a mirror deciding, say, whether one nostril is larger than the other or worrying whether your breasts point in different directions (typical teenage obsessing), do you outgrow this madness or make more radical choices if your mother comes home with larger lips, a smaller ass, a new chin, a different nose, bigger breasts? How do you feel if your mom suddenly doesn't have any expression in her face? Or if you look into your mother's eyes and no one is home?

Your main job as a teenager is to learn to love yourself. How can you do this if your mother hates herself?

In my research, what was so startling was how aware all the teenage girls were of their mother's fear, or, more accurately, their hatred, of aging. One girl said, "Every time I wrinkle my forehead, my mother points it out and tells me not to. Even if I'm in the middle of a really important conversation." Another spoke about "competitive dieting" with her mom, how she couldn't help but engage in it even though she thought her mother's obsession with fat was "crazy." There is a study out this week from the Girl Scouts of the USA telling us what we already know, which is that the fashion industry and its use of ultra-thin models is making teenage girls too obsessed with being skinny, and distorting their body image. In my more limited unscientific research, the mothers are as strong an influence. Going on shopping trips with mom, usually a bonding experience, became all about hearing moms moan about their fat and rolls. Or seeing your mother trying on something, look in the mirror and say, ""I look ugly."

I have vivid memories of my own adolescence when the main purpose of shop windows was not to see the clothes in them but my own reflection, when hours could be spent in front of a mirror deciding if my eyebrows matched. Emotionally, teen life is no different today, but now you can act on your own insecurities. You can fix them.

A lot of healthy acting out occurs in the mirror, as my research showed. Singing and dancing and even telling off people who hurt your feelings or trying on new identities. But there was also a lot of obsessing about body image. One girl got dressed using four mirrors, running from one to the next: one had good indoor lighting, one was a "skinny" mirror, one had natural light, one she could get the closest to. "If something is wrong with you," a teenage girl said, "the mirror magnifies it." Another said, "If I think something's wrong with me, like my thighs are too fat, when I look in the mirror that's all I see."

God knows, I am not advocating growing old naturally, just to remember what a tender fragile time adolescence is. In my research, one teenage girl confided, "Seeing my mother after her surgery scared me to death." We need our moms to be stable and secure. I have so many friends who will tell me with surprise, when looking at photos of themselves when they were younger, "Hey, I was really cute. I didn't realize it." No one does. You have to get older to realize it. Imagine if you got older and realized that you'd destroyed your younger self. You had operated it away.

Now that's something to cry about.

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* Take it from one who knows..... that IS something to cry about. -Lucille