FDA raises further concerns about Allergan breast implants
There have been reports from the USA that the agency responsible for medical device safety, the FDA, has taken further action against the breast implant manufacturer Allergan.
Posted on 20 May 2020
Reports indicate that on Thursday 14 May 2020, the FDA served warning letters on Allergan and a much smaller company called Ideal Implant for violations of the agency’s safety protocols.
In particular, the FDA is concerned that Allergan have failed to comply with so-called ‘post approval study requirements’ for two of the models of breast implants recalled from the market last year following interventions by the FDA.
In July 2019 all of Allergan’s Biocell textured implant range was withdrawn globally due to concerns regarding an association between breast implants and the development of a novel and uncommon type of cancer known as Breast Implant Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL.
Post approval study requirements include an obligation to continue to study and monitor the impact of a medical device in those implanted after the date at which the device is first approved for market. The purpose of post approval studies is to ensure that accurate data can be collected about how the product performs and, also provides an early warning system in the event that there are problems with a device. The FDA imposes post approval study requirements on all manufacturers of products that are categorised as Class III, or implantable – high risk devices, and the latest reports indicate that Allergan has failed to submit appropriate data.
Zahra Nanji, who represents women affected by BIA-ALCL in the UK comments:
“The latest news from the FDA is concerning. Whilst Allergan Biocell implants have now been withdrawn globally, they remain implanted in thousands of women worldwide, many of whom are now aware of the association between Allergan implants and the cancer BIA-ALCL, but whom are unable to afford the cost of removing and/or replacing their implants. For that group of women it is vital that Allergan and other implant makers continue to monitor the safety risks of their products. Just because Allergan no longer has a commercial interest in these studies, in terms of growing its market share, it still has a duty to thousands of women globally with these implants already in situ.”
Zahra Nanji commented:
“History tells us that it is not enough just to rely upon pre-market studies to determine the efficacy of a product. Previous cases such as the PIP Implant Litigation and the Metal-on-Metal Hip Litigation highlight the importance of not only ongoing monitoring but also the need to have the ability to track the lifecycle of an implanted device. We should be able to tell people when evidence emerges that a medical device which they have had implanted to improve their life has the potential to put that life or their quality of it at risk.”