Making Sense of the French Silicone Breast Implant Scare

Europe’s debt and currency issues were briefly pushed aside when France recently announced that about 30,000 women should have removal of substandard silicone breast implants.   Manufactured by Poly Implant Prothese SA (PIP), these devices may have a higher than normal rupture rate, and the company has been accused of using inferior, non medical-grade silicone.

Silicone breast implants have had a convoluted history in the United States, and were taken off the market for cosmetic use from 1992-2006.  They were reintroduced with a new gel design and enhanced documentation and follow-up recommendations.  Since silicone breast implants tend to touch off fireworks whenever they are in the news, here are a few points for Americans to keep in mind.

1)       These silicone implants are not the ones used in the U.S.  Ours are different, and the FDA warned the French company of manufacturing problems back in 2000.

2)      The implants haven’t yet been proven to cause serious health effects.  It will take time until experts can determine what, if any problems will be attributed to the inferior materials.

3)      The potential safety issue is not the use of silicone in breast implants, but the use of non-medical grade material in the French devices.

Five years following the reintroduction of silicone breast implants in the U.S., an FDA review deemed them safe for use.  The association with a very rare form of lymphoma was noted.

The French case says more on the issue of proper government oversight of product safety than it does about the safety of properly-designed silicone breast implants.  The FDA deserves credit for their report regarding PIP’s manufacturing problems.  However, there are many questions that have yet to be answered as to why French authorities took so long to discover and act on the problem.

Related articles

• Despite Risks, Silicone Breast Implants Still Considered Safe (bellasugar.com)
• Breast implant scandal firm ‘used same faulty silicone in prosthetic testicles’ (mirror.co.uk)

Interim CMS Director Steps Down, Problems Remain

The resignation of Don Berwick as director of CMS didn’t seem to get major press coverage. Dr. Berwick was appointed to lead CMS in July 2010 when Congress was in recess, and thus needed Congressional approval to serve beyond 2011. He quickly became a punching bag for some lawmakers, who attacked his purported admiration of the British National Health Service. He was also subjected to criticism for a prior statement on health care rationing. I previously commented on his exact statement here, and noted that the criticism appeared to distort the factual record.

Realizing that the Senate would not confirm him, he has stepped down.

By all accounts Dr. Berwick is an upstanding physician with a solid reputation. And the problems that he so accurately noted will not be resolved by his resignation. The position of CMS Director increases in importance every day as the government debt pile grows larger, fueled in large part by healthcare expenditures. This problem will not be solved without co-operation from both political parties.
The fact remains that the government has simply promised much more health care than it is capable of providing, and some method of matching these promises with the forces of reality will take place. This can be through price rationing, non-price rationing, large tax increases, or some combination of the three. But what has been happening will not continue indefinitely.

Dr. Berwick may have been criticized for speaking the truth on this matter, but he is no different from a new CFO brought in to aid a struggling business. When the business owner later receives a report saying “Something major has to change or you are headed for bankruptcy.” Should he fire the messenger?

Regardless of who leads CMS, the mathematical problems with Medicare and Medicaid will not go away. Best of luck to the next director!

Related articles

• Obama’s Pick to Head Medicare and Medicaid Resigns Post – Ocala (ocala.com)
• Statement On Dr. Donald Berwick’s Departure As Administrator Of The Centers For Medicare And Medicaid Services (medicalnewstoday.com)
• US Medicare chief to resign after political standoff (trust.org)
• A Vacancy That Needs to Be Filled (nytimes.com)

Junk in the Trunk: Amateur Buttock Enhancements can Kill

The arrest of a Florida man for allegedly performing buttock injections with a variety of home-improvement products may seem shocking to outside observers.  Not so in South Florida.   We see a few a month.   Some are not happy with the results; it’s lumpy, uneven, or otherwise abnormal.  Those are just some of the patients.  To see the others, we’d have to make rounds at the cemetery.

Amateur buttock enhancers are fairly prominent in the region, where there is higher than average demand for all sorts of cosmetic procedures.  Buttock shaping is a popular procedure, and is fun and fairly straightforward to do.  Properly selected patients tend to do well and satisfaction rates are high.

Perhaps due to the economy, or to ignorance, some people allow lay-practitioners (some may be partially medically trained) to inject substances into their buttocks, hoping to get the same effect as a proper cosmetic surgery.  There are two things to keep in mind regarding this concept:

1. There are only two medically legitimate ways (in this country) to reliably augment the buttocks:  with silicone implants or with fat grafting.

   Silicone implants are less commonly done since there are generally higher rates of complications than with fat grafting.  They can be appropriate for thin patients who do not have enough donor area fat.  But in general, fat grafting is the preferred procedure and makes up the majority of buttock enhancing procedures.

2. Home-improvement substances such as caulk, silicone, Fix-a-Flat and cement (to  name a few) are not supposed to be put in your body.

   Though this should be obvious, not everyone realizes it.  These substances are not designed for medical use, and can have all sorts of complications.  There can be infection, hardening or destruction of tissue, and embolization (stuff entering blood vessels and clogging up the lungs or other organs).  Any of these events can lead to irreparable tissue problems, disability, or death.

Some victims may believe that they are under the care of real medical professionals, (though I don’t know too many colleagues who perform procedures in basements or hotels).  Others may not think these substances are harmful, or believe they are legitimate in other countries but not in the U.S. (they’re not).

Here is a brief list of similar incidents:

Miami, June 2008

Miami, September 2010

Las Vegas, April 2011

Related articles

• ‘Buttock cement fixer’s bum deal’ (thesun.co.uk)
• Buttock enhancement is ‘the new boob job’ (mya.co.uk)
• Illicit silicone injections risky, even deadly: doctors (ctv.ca)