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."

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!

Slow news day: Ivivi - Allerghan deal & the election's effect on silicone breast implants

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.


tags:
breast implant
plastic surgery
silicone
Ivivi
Allergan

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.


tags:
breast implant
plastic surgery
silicone
Pat Maxwell

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.