Breast Implants: What is the Difference between the CE Mark & FDA Approval?
With increasing numbers of ladies currently opting for implant replacement (following the recent PIP implants scare) this question is on the minds of many. However, straightforward information about FDA approval and the CE Mark is not always easy to find.
This has led to confusion and, unfortunately, some scaremongering on popular forums and social media platforms about whether one type of implant is better than another.
In this blog, Aurora Clinics hope to make things clearer, offering information and reassurance for those researching the best breast implants for their breast enlargement surgery.
What Is FDA Approval?
- A form of regulatory sanction granted by the Food and Drug Administration
- They assess medical devices (like Breast Implants) according to safety and effectiveness
- A risk classification from 1-3 is given to decide if the product is safe to sell on the open market
Since 1988, Breast Implants have been classified Class III High Risk by the FDA so require the most stringent application procedure for approval, known as a PMA (Premarket Approval Application).
This means the manufacturer must submit clinical data and research to back up any claims about the product. They also have to prove that their implants are not only safe but effective too.
The important thing to note is that the FDA are an American governing body who (according to their website) only monitor and approve the manufacturing, repackaging, re-labelling and importing of medical devices which are sold into the USA market.
This obviously means that if a product is not an American brand and the company has no intention of trading the product into America, there is no need for the product to seek and gain FDA approval.
What Is the CE Mark?
- Essentially the EU equivalent of FDA Approval
- A set of legal requirements / a declaration of conformity for all medical and aesthetic devices which must be rigorously followed before they can be sold on the European open market
- Manufacturers must comply with European health, safety and environmental Product Directives, with the product meeting set standards for safety and quality
- Non-conforming products can be withdrawn by customs and law enforcement officials.
As with FDA Approval, because Breast Implants are designated Class III (high risk) medical devices, they require a CE Medical Mark rather than a standard CE Mark which ensures the same depth of clinical data and research is submitted before a product can be approved for open market sale. The CE Medical Mark also guarantees that the device has been tested not to interfere with hospital equipment, particularly life-saving apparatus.
Are Implants with FDA Approval necessarily Higher Standard than those with the CE Mark?
Not at all. This is a common myth which has developed in the UK through lack of understanding and information.
It has grown due to unchecked rumours on forums and social media, coupled with the American suppliers / providers obvious eagerness to exploit this belief to seem as if their products are somehow superior, regardless of the lack of factual foundation.
Part of the confusion may stem from the fact that lower classed devices in the CE Mark system do not require clinical research data in order to gain approval. (The Medium Risk device classifications on the FDA system, however, also have to submit far less rigorous clinical data and receive clearance much more easily.)
This may have been misunderstood and applied to Breast Implants when, in fact at this level, the two systems are much of a muchness just one is European and the other American.
In his brilliant article CE No Evil for Cosmetic News magazine (December 2011, p.22-24), Mike Murphy concludes by admitting that neither CE nor FDA approval guarantees that medical/aesthetic equipment will deliver good clinical results. They are essentially safety tests with large variations in clinical efficacy.
Nagor and Allergan Implants
When it comes to Breast Implants, Aurora Clinics are finding many worried women trying to choose between Nagor (which has the CE Mark) and Allergan (which has FDA approval) using these regulatory approvals as a deciding factor.
The simple fact is that Nagor is very much a UK, proud-to-be-British implants company and therefore have never traded into the US or particularly needed an FDA approval. Allergan, on the other hand, are American so do.
That said, Nagor provided a statement for Aurora explaining that ”although we are not selling products in the US, products manufactured from our facility are currently progressing through the FDA approval process”.
In 2005, the FDA visited the Nagor facility and deemed its systems satisfactory at that point. Nagor also add that they are certified throughout the world by other stringent health authorities including TGA (Australia), Anvisa (Brazil) and SFDA (China).
In terms of efficacy, Aurora has a very good track record with both of these brands and our surgeons are happy recommending either as excellent quality breast implants.