The Smooth Spectrum Saline Implant Leakage Rate

 

Sir:

Much confusion exists with regard to the leakage rates of saline implants. Leakage in saline implants may be the result of valve failure or shell failure. What is clear is that textured saline implants have a higher leakage rate than smooth saline implants. Saline implants currently have diaphragm valves, which have a lower leakage rate than the leaf valves they replaced. Spectrum implants (adjustable saline implants) have a triple-valve system, which has an even lower leakage rate than the diaphragm valve.

There is a misconception among surgeons that Spectrum implants have a higher leakage rate than regular saline implants. This misconception arises from advertisements and consumer-oriented documents that Inamed (Irvine, Calif.) and Mentor (Santa Barbara, Calif.) have published.

The published data would seem to indicate that Spectrum implants have the highest leakage rates. However, as Table 1 shows, published data on leakage rates are incomplete. On the one hand, Inamed has not published data on textured implant leakage rates; on the other, Mentor has not published data on smooth Spectrum implants. A study was therefore undertaken to assess the leakage rate of Smooth Spectrum, which has not been previously published. A total of 366 implants were reviewed. These data are reflected in Table 2.

Deflation/ruptures occurred as follows: three ruptures at year 1 (at 4, 6, and 13 months), two ruptures at year 2 (12 and 21 months), and one rupture at year 8 (91 months).5 The 7-year leakage rate for Smooth Spectrum implants is 1.09 percent, which is lower than published rates for any other saline implant. The low leakage rate of the Smooth Spectrum implant is related to the lack of texturing and the superior Spectrum valve.

DOI: 10.1097/PRS.0b013e31817d6616

Hilton Becker, M.D.
Boca Raton, Fla.
Correspondence to Dr. Becker
5458 Town Center Road
Boca Raton, Fla. 33438

REFERENCES

  1. Surveillance (ConfidencePlus) data from 1997 to 2005, cited in INAMED advertising.

  2. Mentor Corp. Mentor advertisement, Past Reconstr. Surg., data from Mentor Saline Prospective Study (SPS).

  3. U.S. Food and Drug Administration. Saline-filled breast implant surgery: Making an informed decision. Mentor Corporation, January 2004. Available at: www.fda.gov/chch/ breastimplants. Accessed June 5, 2008

  4. Mentor Corp. Directions for Use: Mentor Saline-Filled & Spectrum Mammary Prostheses. Santa Barbara, Calif.: Mentor Corp., 2005. Publication No. 102876-001 Rev A 1/05.

  5. Becker, H. Unpublished data.

DISCLOSURE

Dr. Becker has an interest in a company that receives royalties from Mentor Corporation.