FDA approval and inspection process mostly protected American patients from allegedly defective French breast implants

December 27, 2011
Pharmaceutical Commerce, Pharmaceutical Commerce - November/December 2011,

A ‘media frenzy’ is ramping up in France and other countries over health authorities’ call for remedial action; meanwhile, US Congress looks at increased review of medical devices

This story involves medical devices (breast implants) and not drugs, and the details are still coming together even as a near-panic is arising in Europe over implants that contained non-medical-grade silicone from a now bankrupt company, Poly Implant Prothese, at one time one of the leading implant producers. But according to a Reuters report, PIP’s products were reviewed in 2000 by an FDA advisory panel, which recommended not approving the product because incomplete clinical data. An FDA inspection of PIP’s La Seyne Sur Mer facility was carried out in May 2000, and a month later FDA issued a warning letter alleging numerous manufacturing deficiencies. The upshot: PIP had to stop selling its saline implants in the US, and apparently never tried to sell the silicone implants that are now the cause for concern in France.

PIP’s problems came in waves, and over the past decade, FDA’s medical device review process has also evolved. The company was able to sell its saline implants during the mid- to late-1990s in the US; no implant maker was allowed to sell silicone implants until after 2006. Saline implants had been approved under the FDA 510(k) program, which essentially approves new medical devices based on similarities to existing ones, but the implants were required to undergo a more stringent approval process in 2000, and that is when PIP’s products stopped being sold in the US. Meanwhile, at some later time, PIP began selling silicone implants, and various press reports estimate that 300,000 or more were manufactured by the company until 2010, when it shut its doors, after the discovery that the company had been using industrial-grade silicone, with undetermined purity, rather than medical-grade silicone. Earlier this year, reports of at least one patient dying of cancer led to the recommendation, in late December, that French patients (numbering some 30,000) would be reimbursed for removing the allegedly defective products.

Now, health authorities across Europe are meeting to determine next steps, and whether to follow France’s lead. The products were widely distributed in South America as well. British authorities are not convinced that the implants represent an imminent threat, and a spokesperson for the British Association of Aesthetic Plastic Surgeons is quoted in The New York Times as saying, “The message here is not to panic”—which, given the circumstances, might be the exact opposite of what patients will decide.

Congress considers legislation

All this was happening just as Congress was making motions to tighten the regulatory review process for medical devices. Senators Charles Grassley (R-IA), Herb Kohl (D-WI) and Richard Blumenthal (D-CT) introduced a bill, the Medical Device Patient Safety Act, on Dec. 15. This was not a reaction to the PIP scandal, but rather earlier questions about the safety of hip implants and vaginal meshes, and a Government Accountability Office recommendation earlier this year for beefed-up FDA reviews. The bill could be folded into legislation for a medical devices user fee act under consideration by Congress.

Both because of the unfolding scandal in France, and the coincidence of new federal legislation, the situation is hauntingly similar to the oft-told story of how FDA prevented most US women from thalidomide, which was found to cause severe birth defects in the early 1960s. That story was recently recounted by Dr. Jerry Avorn in the New England Journal of Medicine’s December 8th issue. “We are learning how best to use modern methods of evaluation and surveillance to identify as early as possible drugs that pose unacceptable risk and to constrain or prevent their use,” Avorn concludes, “ Yet debate continues on whether and how the federal government should restrict the use of medications with unacceptable risks.”