documenting the neurological impact of exposure to silicone

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DOCUMENTING THE NEUROLOGICAL IMPACT OF EXPOSURE TO SILICONE

Mark B. Hutton and Liz Dudley R.N.

Women with silicone breast implants present with symptoms of various autoimmune diseases, inflammatory conditions and conditions which produce immune dysfunctions. These diseases and conditions can also cause neurological signs and symptoms. A few disease conditions which commonly manifest symptoms of peripheral neuropathy and cognitive dysfunctions include: Sjogren's Syndrome1, Lupus2, Mixed Connective Tissue Disease, Lyme Disease, Syphilis, HIV and amyloidosis.

Those implanted with silicone breast implants, who are symptomatic, exhibit a variety of neurological symptoms, including peripheral neuropathies, cognitive dysfunctions, inner ear disease and a "multiple sclerosis-like" syndrome. These have been documented in the literature by various clinicians, including rheumatologists, immunologists and neurologists. Implant manufacturers involved in breast implant litigation have presented expert testimony claiming that there are no neurological symptoms caused by breast implants. One expert, Neil Rosenberg, M.D., has written an article entitled "The Neuromythology of Silicone Breast Implants" published in the Journal of Neurology, Vol. 46, pp. 308-314, Feb. 1996.

The following literature documents the clinical evaluations and presentations of implanted patients who are exhibiting a variety of neurological signs and symptoms, including cognitive deficits:

Drs. and Campagana reported at the 1995 American College of Rheumatology annual meeting3: 65% of patients reported cognitive dysfunction (most commonly short-term memory loss) (53%) and difficulty with calculations (33%), concentration (16%), directions (9%) and word finding (8%).

Drs. Prange, Silverman4 et al, performed neuropsychological evaluations on a subgroup of Silicone Implanted women and found the following: Of this sample neuropsychologists assessed that 60.9% demonstrated neurocognitive deficits consistent, at least in part, with chronic solvent exposure, with only 3 of 69 (4.3%) strongly suspected of malingering.....Several findings suggested that the right cerebral hemisphere was slightly compromised more than the left.

Shoaib, et al (1994) reported that "Memory Problems" were one of the "Commonest Symptoms" and was reported at a frequency of 81%.5

Brown (1993) et al presented data on 15 breast implanted women with complaints of cognitive dysfunction in whom brain SPECT scans and psychological testing were performed. They found statistically significant decreases in the bilateral temporal regions of SPECT scans along with impaired memory.6

The pattern of cognitive dysfunction presented by symptomatic women with breast implants is similar to other connective tissue diseases, as documented in the article by Carbolte (1994):7

We have found that more than 25% of SLE patients, irrespective of NP status, showed significant problems in areas such as verbal and non-verbal memory,visuographic skills and verbal productivity (word finding). As even larger proportion of patients with current or previous NP symptoms showed problems in psychomotor speed and cognitive flexibility, both sensitive indices of CNS compromise. ... A working hypothesis to explain the mechanism of cognitive dysfunction in SS (Sjogren's Syndrome) has been lymphocytic infiltration in the CNS; this has been supported by abnormal findings in the cerebral spinal fluid, reminiscent of multiple sclerosis (oligoclonal bands,increased IgG index) and the existence of behavioral abnorm alities in MRL-1pr mice with disease which may represent a form of SS secondary to SLE. Pg. 1368.

The eosinophilia-myalgia syndrome (EMS) is a newly recognized multi-system rheumatic disorder described in 1989, occurring in association with the ingestion of L-tryptophan containing products.... in one report approximately one-half of the affected individuals reported difficulties in short-term memory and logical thought, while in the second, significant cognitive complaints reported initially and up to 25% of the patients, found to persist in most of them, now appear to anew in another 16%, despite considerable improvement in other symptoms. Pg. 1370.

Marotta, Batich and Hardt (1996) documented the migration of silicone gel from ruptured breast implants into the brains of rabbits.8 Garrido, et al reported elevations in brain metabolites of implanted women versus controls.9

Vestibular and sensory losses have also been reported by Dr. R.J. Grimm10 who noted abnormal neurological exams in 43 out of 45 silicone implanted women. The neurological abnormalities consisted of a mild, distal sensory neuropathy in the hands and disequilibrium due to vestibular end organ deficits (laboratory confirmed in 32). Of interest, and consistent with other clinicians, was the fact that all had signs and symptoms of "ACTD" in addition to the neurological abnormalities.

Dr. F. O. Black has also reported on the vestibular and auditory function abnormalities in silicone implanted women.11 Auditory and vestibular function tests were obtained from 19 women with ruptured SBI and were compared to matched, asymptomatic SBI control group and with a published, age matched normal database. His results were as follows:

Sixty-seven percent of SBI subjects (SBIs) had abnormal positional nystagmus (32% of normals), 6% had abnormal Hallpike tests (2% of normals), and dynamic posturography sensory organization tests were abnormal in 100% (17% of normals). Vestibulo-ocular reflex function was comparable to that of normals. Sensorineural hearing loss was documented in 39% of SBIS (24% of normals). Based upon these findings, immune esponse to silicone compounds appears to be associated with pathologic changes in vestibular and auditory function.

Dr. Sander Greenland, an eminent medical epidemiologist who gave a presentation to the MDL 926 Science panel in July, has also examined the association between silicone prostheses (non breast implants) and connective tissue disorders and neurologic diseases in a recent case control study utilizing an insurance claims database.12 The results were as follows:

All analyses exhibited positive associations between implants (both silicone and metal) and neurologic conditions, especially idiopathic progressive europathy and Meniere syndrome, as well as the expected associations with arthritic conditions....In conclusion, further studies of prosthetic implants and neurologic diseases appear warranted.

Thus the "myth" of silicone-related neuropathy is dispelled by a review of the literature and clinician's reports. Some patients with silicone prostheses who have systemic signs and symptoms develop neurological abnormalities consisting primarily of peripheral neuropathies, cognitive dysfunction and vestibular/inner ear disorders. Some patients also develop a multiple sclerosis-like syndrome, which is different from the idiopathic form in that they also have coexisting signs and symptoms of "ACTD" (rheumatological /chronic inflammation systemic symptoms).

ENDNOTES

1. Whaley, K., et al, Sjogren's Syndrome, Textbook of Rheumatology, Eds. Kelley, , et al., 3rd ed., pp 999-1019 (1989).

2. Woods, V., et al, Pathogenesis of Systemic Lupus Erythematosus, Textbook of Rheumatology, Eds. Kelley, et al., 3rd Ed., pp 1077-1100 (1989).

3. , ; Campagana, Joan, et al, UCSF of San Francisco, California; Clinical Characteristics of 343 patients with Breast Implants, Abstract presented at the American College of Rheumatology annual meeting, October 1985.

4. Prange, R., Boksenbaum, S.J., Erblich, J., Silverman, S.L., Cedar Sinai Medical Center and UCLA School of Medicine; Preliminary Neuropsychological Findings on a Subgroup of Silicone Breast Implanted Women, presented at the National Institutes of Health, 1995.

5. Shoaib, B.O.; Patten, B.; Calkins, D.; Adjuvant Breast Disease: An Evaluation of 100 Symptomatic Women with Breast Implants or Silicone Fluid Injections, Keio Journal of Medicine, Vol. 43, No. 2, pp 81, Table 1,(1994)

6. Brown, ; Patten, B., et al; Silicone Breast Implants: Association with Abnormal SPECT Scans and Memory Defects, 15th World Congress of Neurology, Abstract Journal (09/93)

7. Carbolte, R., Denburg, S., et al; Cognitive Deficit Associated with Rheumatic Diseases: Neuropsychological Perspectives, Arthritis and Rheumatism, Vol. 38: 1363-1364 (1994)

8. Marotta, J.; LaTorre, G.; Batich, C.; Hardt, N.S.; Yu, L.; Measurement of Silicon in Tissue Sites both Adjacent to and Distant From Ruptured and Intact Silicone Breast Implants, Fifth World Biomaterials Congress, Abstract, May 29-June 2, 1996, Toronto, Canada.

9. Garrido, H.; MRS Brain Study of Women with Breast Implants, 5th Scientific Meeting Abstract, Vancouver, Canada, April 12-18, 1997.

10. Grimm, R.J.; Vestibular and Sensory Losses in 46 Women with Silicone Breast Prosthesis: Preliminary Studies (1994), Poster presentation, 5th Legacy Sci. Fair, (1994)

11. Black, F.O.; Vestibular and Auditory Function Abnormalities In Silicone Breast Implant Patients, Presented at the American Otological Society Combined Otolaryngological Spring Meetings, May 6-10, 1997,sdale Arizona.

12. Greenland, Sander; Finkle, W.D.; A Case-Control Study of Prosthetic Implants and Selected Chronic Diseases, Ann. Epidemiol., Vol. 6: 530-540 (1996)

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