Several instances of faulty implants have recently put pressure on regulatory bodies to examine if they need to better track devices postapproval. In the US, this pressure has occurred amid concerns over metal-on-metal hip implants, which we've discussed previously. In response, a bill was introduced recently that, if passed, would allow the Food and Drug Administration (FDA) to compel manufacturers to track implant performance postapproval and would also increase scrutiny on recalls. Although some advocacy groups think that the entire 510(k) approval process which only requires that devices prove that they are substantially similar  to other already available devices needs to be more rigorous overall, any changes requiring more premarket testing would likely be met by strong backlash from the industry. In fact, several bills have recently been introduced that would streamline the US approval process to bring devices more quickly to market, and the FDA has also committed to reducing approval times.

In Europe, regulatory bodies are struggling to figure out how to react to the recent scandal surrounding faulty breast implants provided by French manufacturer Poly Implant Prothèse (PIP). These implants used non medical-grade silicone and there have been reports of ruptured implants as well as concerns over leakage of the silicone into the body. This situation differs from the metal-on-metal hip implant conundrum in the US in that the manufacturer clearly misbehaved in this case the CE marking was originally granted with one implant material and PIP later changed the material without notifying the regulatory body. Nonetheless, this has also raised the question of postapproval tracking of implant success many people are wondering how these implants ended up being inserted into approximately 300,000 to 500,000 women worldwide. Additionally, the question of who pays for the removal of the faulty implants is up in the air, although so far France, Germany, and the UK regulatory bodies had announced that they would pay for these procedures.

Similarly, concerns have been raised over dermal fillers such as hyaluronic acid, which are generally not regulated as strictly as pharmaceuticals in Europe. Although nothing as extreme as the PIP breast implant situation has occurred in this area yet, some publications have suggested that this might be where the next major health scandal could occur given the high demand for cosmetic procedures in the region.

In the cosmetic world, these events seem to signify the victory of cost over quality patients want the procedures but aren't willing to pay a lot, which is causing manufacturers and doctors to find low-cost options. Ultimately, however, this may unfortunately put patients at risk, which puts regulatory bodies in the position of attempting to better track devices postapproval.

Pivoting a product launch during the pandemic

View Now