Archive | January 2011

FDA: Breast Implants Possibly Linked to Rare Cancer

Silicone gel-filled breast implants

Breast Implants

It felt a little like the early 1990’s today when the news broke of the FDA’s report concerning breast implants and Acute Large Cell Lymphoma (ALCL).  Any link between breast implants and disease is sure to get a lot of attention, especially given the history of silicone gel implants and a purported disease link (never proven).   

This finding was termed a “possible association” by the FDA, and will be closely followed.  The FDA recommendations are presented in italics below:

The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:

  • Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online1 or by calling 800-332-1088.
  • Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
  • There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants.  Although not specific to ALCL, health care providers should follow standard medical recommendations.
  • Women should monitor their breast implants and contact their doctor if they notice any changes.
  • Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.

It is important to realize that ALCL is an extremely rare disease.  The review idendified 34 cases worldwide (possibly as many as 60).  Considering that between 5 and 10 million women are thought to have received breast implants, the risk is probably quite small.  ALCL is reported to have an incidence of 3 in 100 million in women without implants.  Again, an extremely low number. 

Perhaps the most important message to keep in mind is that ALCL is not breast cancer.   As with any announcement of this type, it is best to wait for the science to follow before drawing any conclusions. 

The FDA’s complete report can be viewed here.

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UConn Health Center Runs Into Tough Opponent: Ohio State

UConn experienced two heavy losses over the New Year’s holiday.  The Fiesta Bowl defeat to Oklahoma was disappointing, but achieving a BCS bowl game is still a notable achievement for a young I-A football program.

The other loss was to Ohio State.  Not in football, but in federal grant funding from the Department of Health and Human Services.  During the run-up to health reform, there was the potential for UConn to get a $100M grant for improvements to the facility.  It was not a done deal, but subject to a competitive process.  As with any competitive process, there was the potential for defeat.  Similar to the bowl game, UConn put up a strong effort but fell short.

The funding loss is significant, but the long term question is this:  What is the future of the Health Center?  Can Connecticut taxpayers afford to subsidize the facility year after year?  Can UConn continue to operate the John Dempsey university hospital?  Can it be transformed into a sustainable facility?

It is an important issue, and no option should be off the table.  The United States has about 6,500 hospitals, and that is very likely too many.  Health reform, technology, and economic forces should lead to consolidation and contraction over the next decade.  One of those economic forces is the financial status of individual states.  Connecticut has a troubled financial picture, and might have trouble justifying pouring money into the Health Center year after year.
Having graduated from the institution, I favor scenarios that allow the entire facility to prosper, but it needs to be self-sufficient over time.  Institutions such as Harvard Medical School prove it possible to have a medical school without operating a hospital.

The research capacity of the Health Center can be preserved, and students can continue to get a high-quality education.  That part is easy compared to figuring out what to do with the hospital.  A merger with Hartford Hospital came close, but could not overcome the challenges needed to move forward.

The Health Center’s audited financial statements (the last complete year available is 2008), show operating losses increasing by 16.7% in 2007 and another 19.3% in 2008, to $198.6M.  Drilling down a bit, it is apparent that operating expenses are outpacing the increases in revenue.    Dempsey is the main component of the Health Center’s finances, and if it can be put on solid footing, the rest should follow.  Despite the challenges, it may still be possible to straighten things out and keep Dempsey viable into the future.  How much time there is for this, and how to accomplish it, are the bigger questions.