CORRESPONDENCE

 

SOUTHERN MEDICAL JOURNAL, Vol. 89, No. 1, January 1996, pp. 99-100

 

 

 

7. Snyderman RK, Lizardo JG: Statistical study of malignancies found before, during, or after routine plastic operations. Plast Reconstr Surg 1960; 25: 253-256

8. Morgenstern L, Gleischman SH, Michel SL, et al: Relation of free silicone to human breast carcinoma. Arch Surg 1985; 120: 573-577

9. McGrath MH, Burkhardt BR: The safety and efficacy of breast implants for augmentation mammoplasty. Plast Reconstr Surg 1984; 74: 550-560

10. Berkel H, Birdsell DC, Jenkins H: Breast augmentation: a risk factor for breast cancer? N Engl J Med 1992; 326: 1649-1653

11. Deapen DM, Brody GS: Augmentation mammaplasty and breast cancer: a 5-year update of the Los Angeles study. Plast Reconstr Surg 1992; 8:660-665

 

Reply

 

     The nation's final authority on medical devices, the Food and Drug Administration (FDA), declared that all breast implant manufacturers failed to show proof of safety and efficacy of breast implants whatsoever.¹ That is why the FDA took silicone gel breast implants off the American market for unrestricted cosmetic augmentation.¹

     Dr. Mogelvang admits that he has "dealt successfully with a number of patients with similar complaints to those cited." So, "patients with similar complaints" do exist. Can he tell us how he "successfully" handled them? Did he explant them? In our view, that seems to be the most effective treatment. We believe the implants were responsible for the chest pain in our patients since none of our patients had any cardiac or known noncardiac causes of chest pain and the pain improved or subsided after implant removal.

     Dr. Mogelvang believes "most of the findings . . . would be present in any surgical site . . . ." He is mistaken. Non-silicone breast implant surgeries do not show large amounts of free silicone from bled or ruptured implants in the chest. Most of the silicone that bleeds out of the implants through the intact envelope is the low molecular weight D₄ (octamethylcyclotetrasiloxane), proven to be a strong stimulant to the immune system.²

     Our paper did not make conclusions about whether breast implants can cause systemic problems. However, since Dr. Mogelvang talks about systemic problems, we would like to mention that we have presented evidence in another paper that breast implants can cause an atypical inflammatory autoimmune disease.³ This disease from the implants presents a new disease entity called "adjuvant breast disease." Dr. Mogelvang suggests that stress could account for the patients' problems. We have investigated far over 2,000 patients and among the first 100, 78% had autodirected antibodies, 80% had abnormal results of sural nerve biopsy, 58% had abnormal results of biceps muscle biopsy, 89% had abnormal results of pectoralis major muscle biopsy, and 60% had grossly ruptured implants.³ Some of our patients had had systemic vasculitis causing cerebrovascular accidents, and eight patients had died. So, can Dr. Mogelvang please show how simple everyday life stress can cause these objective findings? We here in Houston, including our patients, would be very happy if he could teach us how to make these findings go away by "changes in family situations."

     We reported a patient whose right silicone gel implant was accidentally ruptured by the needle of her right subclavian central line while she was hospitalized. She then had a scleroderma-like condition in the same distribution as the silicone gel had spilled from her ruptured implant (Figure). Gangrene developed in the right breast, which had to be amputated. Two years later, she died with a systemic scleroderma-like condition, which had not been present before the accident.³

     All of our patients with chest pain were seen by Board-certified cardiologists. Of course, all patients had chest pain before cardiac catheterization. The procedures were ordered by the cardiologists, and not by us.

We would like to inform Dr. Kulig et al that the number of women with implants in the United States is between 304,000 and 815,700.^4,5 Cardiac and known non-cardiac causes of chest pain including depression were ruled out in all patients by consulting physicians. Cuéllar et al⁶ and Silver et al⁷ studied chest pain in breast implant recipients and came to the same conclusion as we did. It should not be surprising that patients with large spills of silicone and dense inflammatory reactions in their chest can have chest pain and that in some cases the pain can be so severe that it simulates a heart attack.

Breast implants in general have been associated with cancer development.^1-8 The polyurethane on the foam implants degrades into carcinogens such as TDA (2,4 diaminotoluene), a classified carcinogen.¹ TDA has been found in breast milk and urine of women with polyurethane implants.¹ Kulig et al gave two references, papers by Berkel et al (reference 10 in the letter of Kulig et al) and Deapen and Brody (reference 11 in the letter of Kulig et al), that supposedly show a lower risk of cancer in breast implant recipients. Unfortunately, both papers have serious problems: According to an article by Robert Walker published in the Calgary Herald,⁹  Dr. Berkel, former director of the Alberta Cancer Board, was "fired by the Alberta Cancer Board because of allegations his research was flawed." The Calgary Herald article also reported: "After Berkel's paper appeared in the New England Journal he was offered a $250,000 US research grant by breast implant manufacturer Dow Corning to continue research."⁹ Deapen and Brody found an over-presentation of lung and vulva cancer in their study.¹

     Finally, litigation cannot cause abnormal laboratory and tissue biopsy results, nor are patients willing to die for it. There are more than 1,500 published research papers in the literature about hazardous health effects of breast implants or the chemicals used in breast implants. The silicone health problem exists and it will not disappear by itself. We need to learn about the problem instead of trying to ignore it.

 

Britta Ostermeyer, MD

Health Sciences Consultant Grp.

3960 Broadway, 3rd floor

New York, NY 10032

Tel. (212) 342 7272

Bernard M. Patten, MD

Department of Neurology

University of Texas

1019 Baronridge

Houston, TX 77586

References

 

1. Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations. The FDA's Regulation of Silicone Breast Implants. Washington, US Government Printing Office, 1992, pp 1-51

2. Lake RS, Radonovich MF: Action of Poiydimethylsiloxanes on the Reticuloendothelial System of Mice: Basic Cellular Interactions
and Structure-Activity Relationships. Midland, Mich, Dow Corning Wright Corporation, Research Department, October 30, 1975

3. Ostermeyer Shoaib B, Patten BM, Calkins DS: Adjuvant breast disease: a clinical evaluation of 100 symptomatic women with silicone breast implants or silicone fluid injections. Keio Med J 1994; 43: 79-87

4. Bright RA, Jeng LL, Moore RM: National survey of self-reported breast implants: 1988 estimates. J. Long-Term Effects Med Impl 1993; 3: 81-89

5. Cook RR, Delongchamp RR, Woodbury M, et al: Breast Implant Prevalence. Midland, Mich, Dow Corning Corporation, March 17, 1993

6. Cuéllar ML, Garcia C, Molina JF, et al: Angina-like chest pain in women with silicone breast implants. Arthritis Rlieu1994; 37.(Suppl): S270

7. Silver DS, Silverman SL, Mendoza M: Chest wall syndrome in patients with silicone breast implants. Arthritis Rheum 1994; 37 (Suppl): S270

8. Epstein SS: Implants pose poorly recognized risks of breast cancer. Int J Occup Med Toxicol 1995; 4: 315-342

9. Walker R: Research in doubt: Cancer Board fires director. Calgary Herald, November 9, 1993