Sunday, July 30, 2006

US Senate panel backs FDA moves on breast implants

More developments in the pending reintroducing of silicone breast implants for primary cosmetic indications. If you recall, both major US manufacturers received approvable letters from the FDA Advisory panel in 2005 and action on these has been pending by the FDA. In the interim negotiations between industry & the FDA have been ongoing over what kind of post-market surveillance and education for surgeons would be mandated, it is these negotiations which have been slow but apparently very close to completion.

Watching the debate develop for close to 15 years on this you can see the shift from concerns by the FDA over cancer and auto-immune disease (which have been settled to most people's satisfaction) to issues re. local complications, rupture rates, and efforts that can be implemented to reduce the instances of those complications. A change in policy re. implants would put the USA in line with the world scientific consensus on the safety of these devices.

This progression towards reintroduction has the political groups lobbying against this in crisis mode. There have been a sequence of desperate claims in recent years, each of which they feel would require indefinite delay in consideration of the device. In years past this was autoimmune disease potential, which has been repeatedly reviewed in the negative. Two large long-term cancer follow ups reported in this year without association. Alleged toxic effects of the platinum catalyst used in manufacturing process were dismissed by the FDA last month.

A number of allegations by these activists, essentially arguing flows in the process of how the FDA considered the devices, was reviewed by a Senate Panel and reported on Friday. It involved a review of the advisory panel proceedings and some various claims of corporate malfeasance by industry.

Once again, the hopes of the silicone-istas were dashed by the outcome of a another review. Claims by activists of improprieties surrounding the government's conditional approval of silicone gel-filled breast implants were largely unsubstantiated, according to the results of a Senate investigation released Friday.

The panel focused on 10 allegations but found only one that was substantiated: a member of a 2005 FDA advisory panel on plastic surgery devices did solicit money from a company owned by Inamed to produce educational materials on the use of silicone implants in breast cancer reconstruction. That relationship was properly disclosed to the FDA and did not violate any laws or regulations, but did present the appearance of a conflict of interest to some of the complaintants.


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