Silicone Breast Implants and Breastfeeding

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Silicone Breast Implants and Breastfeeding

Cheston M. Berlin, Jr. MD

Hershey Medical Center, Hershey, PA

from Breastfeeding Abstracts, February 1996,

Volume 15, Number 3, pp. 17-18.

Over the past three decades, approximately 850,000

women have received silicone breast implants for

cosmetic or reconstructive purposes. Recently,

concerns have come to light about illnesses in some of

these women, especially connective tissue disease

(sometimes referred to as human adjuvant disease), and

in April 1992, the United States Food and Drug

Administration declared silicone implants would be

available only through controlled clinical trials.(1)

Questions have also been raised about the health of

the offspring of these women, especially those infants

who have been breastfed. However, there are no data on

the incidence or length of breastfeeding in these

women.

Breast implants made of silicone materials generate

two issues of concern relative to breastfeeding.

First, do the implants leak silicone compounds into

human milk? Silicone is widely present in the

environment and avoiding ingestion is difficult.

Silicone drops have been used for years in both the U.

S. and Europe for colic. Second, do the implants cause

some type of immunologic disease in the infant? This

could be caused either by prenatal transfer or by

excretion into the milk of an antibody-antigen complex

which then may be absorbed through the infant's

gastrointestinal tract and distributed to target

tissues where a pathologic response may be triggered.

Silicon (Si) is the second most common element in the

earth's crust; oxygen (O), the most common. Together

these two elements comprise 75 percent of the earth's

crust. In its natural state, one silicon atom is

surrounded by four oxygen atoms forming an orderly

three-dimensional network. Silica is the term for both

the simplest SiO2 compound and for its various

three-dimensional structures. Silica is inert and

permitted as a food additive. The only well-documented

human health hazard from silica is a result of

inhaling crystalline silica dust into the lungs,

causing silicosis (pulmonary fibrosis). This type of

silica is never used in breast implants. When silica

lacks its highly ordered geometrical structure, it is

termed " amorphous silica " and is thought to lack the

ability to cause fibrotic reactions. Other important

silicon compounds include silicic acid (where a

hydroxyl [OH] group replaces one or more of the oxygen

atoms) and organosilicates (where organic groups such

as methyl, ethyl or vinyl are attached to the silicon

atom). Any compound which contains an Si-O bond is

termed a silicone.(2)

The compound produced for most biologic implants is

polydimethylsiloxane [PDMS], a silicone polymer which

is insoluble in biological fluids with an average

molecular weight of 24,000.(3) Straight chains of PDMS

are fluids; cross-linked chains of PDMS are gels or

solids, depending on the type and extent of

cross-linking. A silicone elastomer can be produced by

adding amorphous silica to highly cross-linked PDMS.

This is then used as a barrier to surround the PDMS

gel to produce silicone gel implants. The internal

PDMS gel may bleed through the elastomer envelope and

then, engulfed by phagocytes, may be transported

anywhere in the body. Large amounts may produce

granulomas.

Because of the widespread presence of silicon

compounds in the environment, measurement of elemental

Si in biological systems is difficult. However, an

assay of silicone in human milk was conducted by Dow

Corning on six samples of milk from lactating women

with breast implants. This laborious assay requires 10

days to complete and measures PDMS, not elemental Si.

The amount of PDMS in the milk of women with implants

was not statistically different from that in water

blanks or control human milk samples. The milk from

women with polydimethylsiloxane [PDMS] implants, 3.62

ppm; control milk, 3.40 ppm; water, 2.25 ppm.(4)

Another study with more subjects and broader

measurements is underway at Baylor University College

of Medicine.

At least two recent reports have focused on clinical

descriptions of children whose mothers have had breast

implants. In one report, the children, non-randomly

selected, exhibited some physical symptoms which

included abnormal results from motility studies of the

esophagus, recurrent abdominal pain and other

gastrointestinal symptoms, and decreased weight-height

ratios.(5) However, these children were selected by

referral by physicians and support groups responding

to parental concern over possible health effects in

the infant whose mother had implants. Many factors in

this report were not well controlled and bear closer

examination before conclusions are drawn on the

relationship between the symptoms reported in the

children and their mothers' implants. The second

report describes two children with rheumatic

complaints who were breastfed by women with breast

implants. To date, neither child has been diagnosed as

having any connective tissue disorder(6)

These cases reflect an extremely small sample in

comparison to the large number of women who have had

implants. Studies of a larger number of women and

their offspring are critical to any conclusions. We

also need to know much more about the biology of

silicone, its absorption pattern from the

gastrointestinal tract, possible metabolic conversion

in the liver and other tissues, renal excretion, and

binding to tissue protein or bone. Further study,

especially involving genetic studies such as HLA

typing, may reveal certain families at risk for both

maternal connective tissue disease and similar

illnesses in the children. Women with clinical

illnesses suggestive of human adjuvant disease may

represent a subset whose infants may be at a greater

risk. Until such data are acquired, or a more definite

clinical syndrome identified, there should be no

absolute contraindication to breastfeeding by women

with silicone breast implants. (7)

Substantial portions of the article were reprinted

with permission of Pediatrics.

REFERENCES

Council on Scientific Affairs, American Medical

Association. Silicone gel breast implants. J Am Med

Assoc 1993; 270:2602-6.

LeVier, R. R., M. C. on, R. R. Cook and T. H.

Lane. What is silicone? Plast Reconstr Surg 1993;

92:163-67.

Dunn, K. W., P. N. Hall and C. T. Khoo. Breast implant

materials: sense and safety. Br J Plast Surg1992;

43:315-21.

Bejarano, M. A. and M. A. Zimmer. Determination of low

levels of silicones in human breast milk by the

aqueous silanol functionality test. Midland, MI: Dow

Corning Corporation, 1991. Report No.

1991-10000-36332.

Levine, J. J. and N. T. Ilowite. Sclerodermalike

esophageal disease in children breast-fed by mothers

with silicone breast implants. J Am Med Assoc 1994;

271:213-16.

Teuber, S.S. and M. E. Gershwin. Autoantibodies and

clinical rheumatic complaints in two children of women

with silicone gel breast implants. Int Arch Allergy

Immunol 1994; 103:105-8.

Berlin, C. M. Silicone breast implants and

breast-feeding. Pediatrics 1994; 94:546-49.

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