Risks of Immunological Responses to Bacterial and Fungal Complications

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Sent: Monday, March 13, 2000 12:35 AM

Subject: FDA '95 Saline Info SALINE BREAST IMPLANTS

What are the Risks of Immunological Responses to

Bacterial and Fungal Complications after Breast

Implant Augmentation?

Review of the literature: Department of Health and

Human Services, Food and Drug administration, (Docket

No. 95N-0007)

Silicone Inflatable .Breast Prostheses: Information

for women considering Saline-Filled Breast Implants:

Availability, Wed., June 28, 1995. .........

" There is concern, but little information about

possible risks from silicone rubber material of the

envelope. Also, questions have been raised about the

potential of the saline to become contaminated with

fungus or bacteria. If so, these organisms might be

released into the woman's body if her implant

deflated. Characterization of Microbial Presence at

the Surface of Silicone Mammary Implants, Dobke, MD,

Svahn, MD, Vastine, MD, Landon, JM, Stein, PhD,

Parsons, MD., ls of Plastic Surgery, volume 34/

Number 6 / June 1995.

" Results of this study, which indicate no correlation

between the frequency of bacterial detection and time

after implant placement, are in agreement with the

concept that the device is colonized at the time of

implantation or immediately thereafter (minutes to

hours). Bacteria can adhere to the surface of

biomaterials almost immediately after contact. Such

contamination becomes " irreversible " as bacteria

become encased in the biofilm they produce. Clinical

Relevance of Positive Breast Periprosthetic Cultures

Without Overt Infection, d. T. Netcher,M.D.,, Gile

Weizer, B.A., Wigoda, M.D., Louis , M.D.,

Thornby, PhD., and Bowen, M.D., Plastic and

Reconstructive Surgery, vol. 96, No. 5 / Positive

Breast Periprosthetic Cultures / October 1995.

Coagulase-negative staphylococci are known to colonize

the ductal system of the breast.

" There are many unanswered questions that relate not

only to the incidence of periprosthetic microbial

colonization but also to its clinical relevance. "

...... " The incidence of Periprosthetic capsule

" colonization " was higher than we had anticipated

(23.7% of implants). The most frequent isolates were

coagulase-negative staphylococci have been found in

small nodules on heart valves, inhuman blood, and in

skin nodules in patients with nodular

sclerodermatitis.

There are a number of possible reasons why these

bacteria may appear less virulent than other bacteria

but under certain circumstances may evoke a serious

clinical response. Under some conditions, bacteria may

change morphologically into cell-wall-deficient

L-forms. "

" In addition to the less virulent coagulase-negative

staphylococci and Diphtheroids, there were three

positive fungal cultures and a variety of bacteria

that were cultured and are generally considered to be

highly pathogenic, including Escherichia coli,

Enterobacter, Enterococcus, and methicillin-resistant

S. aureus. Fungi (Aspergillus) have been reported as

colonizers of silicone gel breast implants. " " It is

interesting, however that a case report exists where

coagulase-negative staphylococci has been associated

with a symptom complex of myalgias and arthralgias in

the absence of over breast infection. "