Recovering from the breast implant panic

Editorials continue to trickle in....

The editorial from today's Chicago Tribune , reflecting on the treatment of breast implants here in the USA.

The whole episode was a case study in the folly of policymaking by anecdote..... So why did it take a decade and a half for the FDA to let these implants back on the market? One reason is government regulators don't like admitting they were wrong. Another is that they prefer to err on the side of excessive caution. No one will get sick from an operation she is not allowed to have, which means no bureaucrat will be blamed for the illness.



Another comment from the NewsBusters blog titled "Deflating Hysteria: Implant Scare of Early '90s Had No Merit"

From the Saginaw (MI) News "Greed, implants and iffy science"
The FDA's approval this month still doesn't address the shortcomings of a legal system that steamrolled over science and caused manufacturers to suspend or quit marketing of silicone based medical devices. Its anyone's guess how many lives and health hardship that cost....It's a travesty of our product liability system that it took so long and cost so much to give women the choice. The only big winners in this legal-medical saga were the lawyers. (emphasis mine)


From the Business & Media Institute " article "Unhealthy Bias in Implant Stories, Then and Now" which focuses on the media treatment from the early 1990's culminated in the infamous Connie Chung hit piece on "48 Hours"

From AEI comes "Two Cheers for the FDA - The recent decision to allow silicone breast implants was a sadly unusual victory of evidence over fear for the agency."

Holiday Plastic Surgery

Now that the holidays are here, we are doing more plastic surgery than ever. This is traditionally our busiest time of the year. Many people like to have procedures during this period. They have lots of free time to recover. It is easy to fly "under the radar" as they recuperate. They can return to their regular routine following the holidays with their improved and refreshed appearance.

Doing procedures such as Beverly Hills breast augmentation over the holidays does take some planning. People should be certain they have friends or family available to help them during their recovery. They should know what obligations they still have during the holidays and plan accordingly. They should plan all of their follow-ups with us so we can make certain we are closely involved following the procedure. With these steps, holiday plastic surgery is often a great option for people.

Apology long overdue to Dow Corning over silicone implants


One of the true victims perpetrated by the American Silicone Breast Implant crisis of the early 1990's was Dow Corning and it's shareholders. Based on nothing but innuendo, a group strong-armed trial lawyers suited the company out of existence. In fact, Dow is still paying settlement money based on claims we have since demonstrated were largely fiction (to the best of our medical evidence).


You don't suppose the law firms who pocketed tens to hundreds of millions of dollars are offering to refund this now that the FDA has officially come around on this (long after science and the rest of the world did)?


An editorial I found asks this same question.



From the editorial page of Midland Daily News:



Something was missing in Friday's announcement by the Food and Drug Administration that it was lifting a 14-year ban on silicone-gel breast implants: an apology to Midland's Dow Corning Corp. That's the least the agency could do, since it was the FDA's ban on the implants in 1992 that sparked an onslaught of lawsuits -- 19,000 of them -- and forced Dow Corning into Chapter 11 bankruptcy to keep the company afloat.


Billions of dollars later, Dow Corning emerged from bankruptcy. Perhaps along with an apology, the FDA should have offered some help in paying those billions the company had to shell out to settle its legal claims. Isn't that the least the FDA could do, since it played such a huge role in casting doubt about the silicone-gel implants the agency now is saying are safe?


Dow Corning officials, in their response to the FDA announcement, took the high road, simply pointing out that this case shows "the critical need for science literacy and its importance in making informed decisions, as individuals, as government agencies and as a society."


We'll take it one step further. This case shows the problems that occur when a government agency becomes a pawn for a class-action-eager civil lawsuit system willing to take down an innocent company for the sake of the almighty buck.


The FDA's announcement Friday was welcome, but it was more than a decade overdue.

Silicone breast implants approved today!!!!!


Wow! I didn't see this coming so soon. The FDA unexpectedly came in on the silicone breast implant approval. Sometimes it is amazing when science trumps politics as it did with this long overdue approval.

THERE ARE NOW NO COUNTRIES IN THE WORLD WITH ANY RESTRICTIONS ON THE USE OF SILICONE IMPLANTS

From the FDA press release:
“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, M.D., Director, Center for Devices and Radiological Health, FDA. “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.”


"FDA’s decision to approve these implants was based on a thorough review of each company’s clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders.

In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. However, these issues will be addressed further in the postapproval studies conducted by the companies.

“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. ”

12 year old liposuction fallout


A story about a 12 year old undergoing high-volume liposuction continues to draw fire. ABC's Diane Sawyer profiles this in a televised segment you can see here.

I first read about this on Tony Youn's delightful Celebrity Plastic Surgery Blog a few weeks ago. It's been touched on as well in John Disaia's popular "Truth in Cosmetic Surgery Blog", and Plasticized which are the only Plastic Surgery themed blogs I've found worth reading (most blog searches pull up trash which are essentially marketing vehicles with no content)

In a syndicated piece on mynippon.com the ASAPS has commented, including a quote from Peter Rubin, one of the real thoughtful Plastic Surgeons doing both clinical & basic science research on treating obesity after massive weight loss.

The American Society for Aesthetic Plastic Surgery (ASAPS) announced today that there is no scientific evidence to support the safety or efficacy of large-volume lipoplasty (liposuction) for weight loss in obese children. Further, the Society noted that liposuction is not an effective treatment for obesity in any patient - adult or child. The statement was issued in response to recent media reports of an obese 12-year old American female who underwent large-volume lipoplasty.

Clinical studies have demonstrated that (lipoplasty) does not have the same health benefits (e.g., reduced risk of heart disease, diabetes or benefits to metabolism) as diet and exercise. It does not address the important lifestyle and diet issues necessary for long term weight loss success. The best liposuction candidates are close to their ideal body weight and have discrete fat deposits that, when treated, will result in a positive change in contour, not obese patients looking for weight loss.


“This treatment plan sends a dangerous message to our young people, that plastic surgery is a cure for being overweight. That is simply not the case,” said J. Peter Rubin, MD, of the Aesthetic Society’s Body Contouring Committee and Assistant Professor of Plastic Surgery at University of Pittsburgh. “I would question the ability of a 12 year old girl to fully appreciate the scope of possible complications and make a reasonable decision about an elective cosmetic procedure
.”


The treatment offered to this 12 year old seems wrong on so many levels.

Extreme Makeover has now officially jumped the shark


The return of Plastic Surgery reality show "Extreme Makeover" lasted one week after ABC has pulled the plastic surgery series after one low-rated airing.

Thank you God!
It's been a little slow on things interesting me to write about.

Two things off the wire:

1) Good news: Ivivi Technologies has announced a world-wide distribution agreement with Allergan for its devices which should really allow this pulsed magnetic field device company to establish a presence in post-op management of pain & swelling. Allergan is the parent company which owns Inamed (the breast implant & Lap-band manufacturer), BOTOX, some of the new injectable fillers.

2) Bad News: My small Ivivi stock purchase is now slightly underwater from it's purchase price of $6/share! So much for my savvy investing skills. I do have faith that this will rebound as Ivivi becomes wider distributed. How the market valuates things like this escape me.

My prediction that the election results last week will be seized upon to affect the debate on silicone implants seems to be showing signs of coming true. A PR release from N.O.W. issued today specifically mentions this in the context of the new agenda N.O.W. expects to be advanced:
"Rep. Rosa DeLauro (D-Conn.) has introduced the FDA Scientific Fairness Act for Women, which would halt the Food and Drug Administration's approval process on silicone breast implants until the agency can actually establish the life of silicone breast implants and until implant makers can prove the safety of the product"


As has been elaborated here on Plastic Surgery 101 before, this is complete rubbish and reflects a rope-a-dope strategy by the anti-implant crusaders to stall this indefinately. We have a fair number of well-followed patients at a decade+ to estimate failure rates of 4th generation silicone implants (~5-8% rupture rate at a decade) and the forthcoming 5th generation implants (the Inamed 410 "gummy bear") has a recently reported rupture rate of nearly zero (0.3% at 6 years). Safety has also been established for years to everyone's satisfaction (both here and abroad) except the fringe cadre of activists who refuses to accept the published work on the subject.


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Art Shows at Rodeo Drive Plastic Surgery


An emphasis on beauty and aesthetics brings the artistic sensibilities of vastly different mediums together at our Rodeo Drive Plastic Surgery Art Shows. Our first art show was held in June 2006 and was a great success, bringing together our staff, patients, neighbors from the Rodeo Drive area of Beverly Hills and Los Angeles, and fans of fine art.

The Rodeo Drive Plastic Surgery Center is aesthetically designed to be elegant, light, and welcoming. It has proven to be a great showplace for fine art. The center uses stone, bamboo, glass, marble, steel, and the overall layout to create a pleasing environment. The permanent art collection features three original Andy Warhol's and many other noteworthy pieces of art. Dr. Lloyd Krieger, our medical director and plastic surgeon, and Dr. Chris Dannaker our dermatologist, seek to create aesthetics with their plastic surgery procedures and other treatments -- just as with the office design and as our featured artists do with their work.

Our first show featured Adolfo Girala, an emerging, Cuban-born abstract artist. Adolfo is self-taught and believes that his art allows him to dive into the realm of his inner world. His art brings emotion to color and canvas in a way that is completely unforgettable. Adolfo's work is mixed mediums of dry pigments, acrylic paint, modeling paste and different types of gel mediums. Through the use of different particles of metallic flakes, and glazing techniques, he creates an illusion of inner light which can only be truly appreciated in person.

We plan on making these fine art shows a regular feature at our California plastic surgery offices.


Please send questions by email to info@rdps.com or find more information on www.RodeoDrivePlasticSurgery.com.

Breast Implant article quoting Pat Maxwell in Wired Magazine


I saw an interesting article on Wired magazine's website about the pending silicone breast implant reintroduction. It caught my attention as it quoted my friend & mentor, Dr. Pat Maxwell from Nashville,TN in the article.

There's a great quote from him putting into context some of the demands being asked of manufacturers by the anti-implant lobbying groups:

"It's like telling Nokia or Motorola they haven't proved cell phones don't cause brain cancer," said Pat Maxwell, a Nashville, Tennessee-based plastic surgeon and a clinical professor of surgery at Vanderbilt University.

Maxwell helped invent the silicone breast implant marketed by Inamed, which was bought by Allergan for $3.21 billion in March.Maxwell noted that penis implants that have been used for decades are made of the same type of silicone as their breast counterparts. "American surgeons are 15 years behind the times. In Tasmania, of all places, they're shocked that American women don't have access to silicone gel implants," said Maxwell, who was on the Australian island to speak at a plastic surgery conference.



No word yet from the FDA though. I'm watching tomorrow's congressional election closely as I mentioned previously, as this could have an effect on the status of these devices.


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Inictments announced in Massachusetts underground liposuction death

Quick follow up from this post about the death of a Worcester, Mass. women by an unliscenced Brazilian physician performing liposuction in an apartment basement.

From the Worcester (MA) Telgram:
A Middlesex Grand Jury on Tuesday indicted Dr. Luiz Carlos Ribeiro, 49, on charges of manslaughter, two counts of practicing medicine without a license and drug counts. Ribeiro's wife, Ana Maria Miranda Ribeiro, 49, is charged with manslaughter and two counts of drug distribution. The owner of the home where the surgery occurred, Ana Celia Pena Sielemann, 41, is charged with being an accessory before and after the fact of manslaughter and two drug counts.

Making A Beautiful Belly Button


The Rodeo Drive Belly Button

Plastic surgery has become a staple of popular culture, but often, lost in the furor, are simple stories on ways to give patients pleasing results.

At Rodeo Drive Plastic Surgery we specialize in abdominoplasty, commonly known as the tummy tuck. This process is performed on men and women who have excess skin and fat around the abdominal area. It is very useful after pregnancy, or for people who have lost weight.

One thing we have found is that a good looking belly button is crucial to making patients happy with their tummy tucks.

During a tummy tuck, the belly button is removed from its surrounding skin and moved to a new position. But what makes the procedure done at Rodeo Drive Plastic Surgery unique is that the bottom of the belly button is stitched more tightly to the deeper tissue to highlight a natural effect. The result has become known as The Rodeo Drive Belly Button.

Since the standard re-creation of a belly button was often "floating" in the belly, it did not have a natural appearance. The belly button was not attached to the deeper and surrounding tissues in a natural fashion.

The Rodeo Drive Belly Button was created to address these issues during our approach to Los Angeles tummy tuck. It creates a stronger "hood" at the top by stitching the top of the belly button loosely to the deep tissues of the abdominal wall. This creates a solid platform for piercing, and also throws a darker shadow within the hole of the belly button, creating a more natural appearance. The bottom of the belly button is stitched more tightly to the deeper tissues to highlight these effects.

At Rodeo Drive, we're working with younger patients than used to get tummy tucks. Now we're doing the procedure on people in their late 20's and early 30's -- these are women who want it all, family, career and a great body. Many of the women in this generation have their belly button pierced. Current fashion for younger women also calls for low-cut jeans that show off the belly button. We also do the procedure frequently on men, and they want to their belly buttons to look natural when they are at the beach.

This technique for reshaping the belly button during tummy tucks serves these sorts of patients very well. It can be combined with other parts of body contouring. One example is the Rodeo Drive Mommy Makeover. Another is that the procedure can be combined with Los Angeles liposuction.


Lloyd M. Krieger, MD is a Beverly Hills plastic surgeon the founder and medical director of Rodeo Drive Plastic Surgery in Beverly Hills, CA. He welcomes your questions and comments by phone at 310-550-6300 or email at info@RodeoDrivePlasticSurgery.com.

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