Sunday, April 17, 2005

Interesting Precedent

There have been a flurry of stories regarding the FDA's recent decision to allow silicone breast implants back on the market. What is thought provoking about this announcement is the restrictions placed on the manufacturer, Mentor, to ensure that patients receive appropriate care and follow-up. As noted in Surgical Diversions:
But they stressed that sales should resume only if Mentor meets some strict conditions:

  • Prospective patients must sign consent forms acknowledging implant risks, including that they ultimately may break and require removal or replacement.
  • Mentor may sell silicone implants only to board-certified plastic surgeons who complete special hands-on training to insert implants in a way that minimizes odds of breakage.
  • Mentor must open a registry to track how patients fare long-term, and continue more formal studies to nail down how often implants rupture within 10 years, something no one yet knows.
The issue of instructing Mentor to only sell these implants to board-certified plastic surgeons is interesting. What about board-eligible surgeons? What about those surgeons who perform breast augmentation, who are broadly termed "cosmetic surgeons?" There is much to ponder here, and the FDA is making a big statement if it goes through with this proposal. As well, as noted by Surgical Diversions,
I think that if the FDA tries to enforce this second point they are opening themselves up to a restraint of trade lawsuit.
I believe in the board certification process, but because of the vagaries of how physicians are trained, there are a mind-boggling number of "boards" out there, particularly in plastic/cosmetic surgery. Each board is careful to note that they do not want to be viewed as preventing non-certified physicians from practicing their chosen field; that is left up to hospital credentials committees. This is clearly laid out, for example, in the web site of the ABPS:
The Board is not an educational institution, and certificates issued by the Board are not to be considered degrees. The certificate does not confer on any person legal qualifications, privileges, or license to practice medicine or the specialty of plastic surgery.
It is not the intent nor has it been the function of the Board to define requirements for membership on the staff of hospitals, or to define who shall or shall not perform plastic surgery procedures.
Either the FDA is giving the board certification process additional clout (which may be good), or it will have to back down.