FDA compliance inspection shows Sanofi Adventis failed to report serious adverse events to the FDA

There is much redacted information.

Through Freedom of Information, I was provided with an FDA inspection document FEI 3000719690. This is a compliance inspection report. I cant help but wonder, had Sanofi reported adverse events as required, perhaps the FDA would have required more stringent label warnings and marketing precautions and I might not have been harmed. It is interesting to me that the FDA officials documented that during the time period evaluated by inspectors, 08/20/2007 – 07/31/2009, the only Sculptra adverse events reported to the FDA were not from Sanofi Adventis. The FDA had 4 reports made directly to them, of which one is mine, two are from non-mandatory reporting physicians and one from a sales representative. It is interesting that during this inspection it was discovered that (redacted number) of Product Technical Complaints were reported to the company. The FDA investigators reviewed a random 33 of those (larger number redacted) complaints and found it objectionable that many of these adverse events were not reported to the FDA as required under the terms of P030050 and its subsequent versions. In fact Sanofi Adventis reported zero adverse events to the FDA. Reportedly, Sanofi Adventis, a very well staffed knowledgeable multi national drug company was “confused” about what is and is not reporting criteria. I am sure that the wider marketing strategy did not include reporting adverse events so claiming to be ignorant of reporting criteria helps until the larger market approval is achieved.

The large inflammatory granulomatous nodules I am experiencing are certainly not "papules" described to the FDA during the hearings. Furthermore I am not alone. Many people have had serious adverse events from Newfill or Sculptra or Sculptra Aesthetic.

I was told "its the same thing that is used in absorbable sutures". Now I have learned that is NOT TRUE. Sutures are a more amorphous form of poly lactic acid which is intended to dissolve. The 100% poly l lactic acid product used in my face is a crystalline form. The company will not tell me how long it stays in my body. From what I have learned, it could be more then 5 years!! With the clumping that took place in my case it could be far longer. How Dare they Lie to the FDA and Lie to me. I am going to be meeting with both Congressman Tonko and Senator Gillebrant to request further intervention. If the company failed to comply with the terms set forth it should be removed from the market until adequate non Sanofi sponsored safety data is available.