


Best Breast Implant Brand, FDA Studies Mentor & Inamed Saline
Choosing The Right Saline Breast Implant Brand
In a world full of choices, it seems reasonable that there is a choice of breast implant brands, and one can learn of reasons for choosing one brand over another. Even though hundreds of thousands of women undergo breast enlargement every year, there has always been a bit of controversy about the long term durability and consequences of breast implant rupture. A woman who is considering implants will want to do the proper amount of research to come to an intelligent decision on which brand is best.
Breast implants have been on the market for about twenty-five years but have not been declaratively approved by the FDA until just a few years ago. The FDA was nudged into action in response to the problems that arose with silicon implants and consequently developed a set of manufacturing and labeling guidelines that implant manufacturers had to adopt in order to obtain FDA approval. Mentor and Inamed (formerly McGhan) obtained FDA approval in 2004 and posted required labeling for each brand. The information booklet includes advice for the consumer and a guide for the health professional to assist in advising the consumer. The FDA has posted its breast implant labeling information for anyone to read. The brochure includes summaries of retrospective 3-year studies performed by both Mentor and Inamed, excerpted below.
| Complication | Mentor (1264 recipients) | Inamed (901 recipients) |
| Post Implant Procedures | 13% | 21% |
| Implant taken out | 8% | 8% |
| Saline escape | 3% | 5% |
| Capsular Contracture | 9% | 9% |
| Breast Pain | 5% | 16% |
There was a 38% higher rate of required post implant surgical procedures for the Inamed group which included capsular revision, scar or wound revision, and implant repositioning. The studies also contrasted a 69% higher rate of breast pain in the Inamed group. With over 130 listed implant manufacturers, including venerable companies such as Dow Corning and Johnson & Johnson, the FDA has narrowed the field of approved devices to two. No other manufacturers have been able to present strong evidence supported by convincing studies, to merit FDA approval. Cosmetic surgeons usually offer both brands to their subjects, choosing one over the other for esthetic reasons and the availability of different styles and shapes.
The original goal of this article was to gather authoritative data that concludes that one breast implant device stood above all others as superior. The FDA, as reluctant as it appears to have been in involving itself in this thorny matter, has set forth the guidelines by which implant manufacturers can be deemed worthy of consumers' trust. No implant device can yet claim a clearly superior life span or freedom from complications, although two have emerged as worthy of recognition. Consumer groups are calling for longer retrospective studies and improved labeling to reassure consumers beyond a declaration of reasonable safety. It remains incumbent on women to ask for opinions from multiple cosmetic professionals to satisfy their need for the best information about breast implant brands.
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