Since the 1970s, anecdotal reports have described a relatively small n
umber of women who received silicone gel breast implants and later dev
eloped either a recognized rheumatologic disease or unexplained sympto
ms suggestive of an autoimmune disorder. The study reported here exami
ned whether there is any association between the symptoms seen in impl
ant patients and HLA molecules. One-hundred and ninety-nine subjects w
ere evaluated by HLA, typing: symptomatic patients with implants (grou
p I, n = 77), asymptomatic women with implants (group II, n = 3'7), he
althy female volunteers without implants (group III, n = 54), and fibr
omyalgia patients without implants (group IV, n = 31). A statistically
significant 68 percent of group I were positive for HLA-DR53, compare
d with 35 percent of group II and 52 percent of group III. The fibromy
algia patients were strikingly similar to group I women in terms of HL
A-DR molecules, with 65 percent of group IV being positive for DR53. G
roup I also had a statistically significant increased frequency of HLA
-DQ2. Asymptomatic women with implants (group II) had an increased fre
quency of DR1 and DQ1. In addition, 42 percent of symptomatic patients
with implants formed autoantibodies to their own B cells; of these, 8
1 percent were DR53-positive. Although frequencies of capsular contrac
ture and implant rupture were not significantly different in the two g
roups with implants, there were statistically significant associations
in group I between contractures and ruptures and the presence of DR53
and B-cell autoantibodies. These data suggest that symptomatic patien
ts with implants share important genetic characteristics (primarily HL
A-DR53 positivity) that differentiate them from their asymptomatic cou
nterparts. DR53 may be a marker of women who are predisposed by their
HLA genotype to develop symptoms following exposure to silicone gel br
east implants.