Tagged: FDA

P.I.P. Implants: French Health Authorities aware in 1996.

According to French daily Libération, a report delivered this morning to the French Ministry of Labor and Health confirms that P.I.P. implants were tested by independent physicians in 1996 who reported that they found leakage issues.

Moreover, the report cites 41 reported P.I.P. implant malfunctions that year (note that these were saline implants since silicone was banned at the time in France). French inspectors sent to P.I.P. HQ in 1996 noted in their file that “further investigations by qualified physicians would be needed” but the case was then dropped. No explanation as to why.

For those who are not aware, in 2000, the F.D.A. sent a letter to P.I.P. refusing to permit the marketing and sales of its implants in the U.S.

As noted in an earlier post on this subject, a change in device regulations is not the problem here. This is an issue of application of existing rules and better communication between health authorities, physicians and device manufacturers.


US F.D.A. Approves Ivacaftor

Bravo to Vertex for bringing this to market. Molecules to address the genetic basis of a disease are incredibly expensive to develop and market.

Even though this only addresses one of the mutated genes (G551D) that cause Cystic Fibrosis, it brings hope. Respiratory illnesses are horribly painful and I hope that the relief this provides brings happiness to patients, their families and loved ones.

I’m sure that EMA approval is not far behind.

F.D.A. Approves Cystic Fibrosis Drug – NYTimes.com.