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Clinical Policy Bulletin:
Breast Implant Removal
Number: 0142


Policy

Aetna considers the removal of breast implants medically necessary for members who meet the following selection criteria.

For members who have undergone either cosmetic augmentation mammoplasty or breast reconstruction following a medically necessary mastectomy (e.g., mastectomy for breast cancer or a prophylactic mastectomy (see CPB 0227 - BRCA Testing, Prophylactic Mastectomy, and Prophylactic Oophorectomy)), removal of a breast implant and capsulectomy or capsulotomy is considered medically necessary for any of the following indications:

  1. Extrusion of implant through skin, or
  2. Implants complicated by recurrent infections, or
  3. Implants with Baker Class IV contracture associated with severe pain, or
  4. Implants with severe contracture that interferes with mammography, or
  5. Intra- or extra-capsular rupture of silicone gel-filled implants, or
  6. Remnant breast cancer or cancer in the contralateral breast.

For members whose breast reconstruction followed a medically necessary mastectomy (i.e., mastectomy for breast cancer or a prophylactic mastectomy), removal of a breast implant and capsulectomy or capsulotomy is also considered medically necessary for these additional indications:

  1. Baker Class III contracture, or
  2. Extra-capsular rupture of saline implant if the rupture compromises the cosmetic outcome of the implant.

Removal of ruptured saline-filled breast implants is not considered medically necessary for members who have previously undergone cosmetic breast augmentation mammoplasty.

If any of the above criteria for removal of a breast implant is met unilaterally, Aetna also considers medically necessary removal of the implant and capsulectomy or capsulotomy in the other breast if both implants are removed at the same time.

Requests for the removal of breast implants for any of the following indications is subject to medical review:

  1. Baker Class III contracture that does not follow a medically necessary mastectomy; or
  2. Implant removal for biopsy of breast mass that has not been proven to be cancerous; or
  3. Implant removal for a mastectomy or lumpectomy that can be performed with the implant in place.

Silicone Implant Removal for Autoimmune Disease:

Aetna does not consider either of the following medically necessary:

  1. IgG testing in connection with silicone implants (the development of IgG antibodies is neither specific to silicone implants nor indicative of autoimmune disorders); or
  2. Removal of silicone implants for autoimmune disease unless the member meets at least one of the selection criteria listed above (e.g., rupture of silicone-gel filled implant, etc.).

Reinsertion of Breast Implants:

Although Aetna considers the removal of breast implants medically necessary for medical indications even if the implants were originally inserted for cosmetic purposes, Aetna considers the re-insertion of new breast implants cosmetic in this situation.  Aetna considers medically necessary the insertion of initial breast implants and the replacement of breast implants inserted following a medically necessary mastectomy (i.e., mastectomy for breast cancer or a prophylactic mastectomy) or for women with Poland's syndrome meeting the criteria in CPB 0272 - Pectus Excavatum and Poland's Syndrome: Surgical Correction.

Baker Classification:

Class I Augmented breast feels soft as a normal breast.
Class II Augmented breast is less soft and implant can be palpated, but is not visible.
Class III Augmented breast is firm, implant is palpable and the implant (or distortion) is visible.
Class IV Augmented breast is hard, painful, cold, tender, and distorted.

See also CPB 0185 - Breast Reconstructive Surgery.



Background

At the time of the Food and Drug Administration (FDA) hearing on silicone breast implants in February of 1992, the FDA advised that ruptured silicone implants should be removed since the health risks of extruded silicone are not known.  At the same time, the FDA panel acknowledged that asymptomatic rupture may be present in up to 4 % of women with silicone implants, but the FDA specifically did not recommend screening for asymptomatic ruptures.

Rupture of silicone implants can be subdivided into 2 categories: (i) intra-capsular and (ii) extra-capsular.  After implantation, a reactive fibrous capsule is formed around the implant.  If the extruded silicone is contained by this fibrous capsule the rupture is termed intra-capsular.  If the silicone gel is extruded beyond the capsule, the rupture is termed extra-capsular.  Extra-capsular silicone can induce granulomatous reaction and can occasionally migrate to the axillary lymph nodes, producing a lymphadenopathy, which can mimic cancer.  Clinically, extra-capsular ruptures are often associated with a change in size and consistency of the breast.  Extra-capsular ruptures can usually be identified on mammography or other imaging studies.  Explantation of these implants is clearly indicated.

The health consequences of intra-capsular ruptures are uncertain since theoretically the silicone is contained within the fibrous capsule.  Furthermore it is known that intact implants routinely “bleed” microscopic silicone particles, which are also contained within the fibrous capsule.  Nevertheless, an intra-capsular rupture can evolve to an extra-capsular rupture and the FDA has indicated that ruptured implants, whether intra-capsular or extra-capsular, should be explanted as well.
 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
19328
19330
19370
19371
Other CPT codes related to the CPB:
19120 - 19126
19316 - 19380
Other HCPCS codes related to the CPB:
L8020 - L8039 Breast prostheses
L8600 Implantable breast prosthesis, silicone or equal
ICD-9 codes covered if selection criteria are met:
174.0 - 175.9 Malignant neoplasm of breast
611.71 Mastodynia
996.54 Mechanical complication due to breast prosthesis
996.69 Infection and inflammatory reaction due to other internal prosthetic device, implant, or graft
Other ICD-9 codes related to the CPB:
279.4 Autoimmune disease, not elsewhere classified
238.3 Neoplasm of uncertain behavior of breast
611.72 Lump or mass in breast
V10.3 Personal history of malignant neoplasm of breast
V16.3 Family history of malignant neoplasm of breast
V45.71 Acquired absence of breast


The above policy is based on the following references:
  1. Chung KC, Greenfield ML, Walters M. Decision-analysis methodology in the work-up of women with suspected silicone breast implant rupture. Plast Reconstr Surg. 1998;102(3):689-695.
  2. Cook RR, Curtis JM, Perkins LL, Hoshaw SJ. Rupture of silicone-gel breast implants. Lancet. 1998;351(9101):520-521.
  3. Peters W. Rupture of silicone-gel breast implants. Lancet. 1998;351(9101):521.
  4. Cooper C, Dennison E. Do silicone breast implants cause connective tissue disease? BMJ. 1998;316(7129):403-404.
  5. Hadden WE. Silicone breast implants: A review. Australas Radiol. 1998;42(4):296-302.
  6. Beekman WH, van Straalen WR, Hage JJ, et al. Imaging signs and radiologists' jargon of ruptured breast implants. Plast Reconstr Surg. 1998;102(4):1281-1289.
  7. Middleton MS. Magnetic resonance evaluation of breast implants and soft-tissue silicone. Top Magn Reson Imaging. 1998;9(2):92-137.
  8. Archer RR. Breast implants. Plast Reconstr Surg. 1997;100(2):555.
  9. Claman HN. Autoimmunity after silicone breast implants. Ann Allergy Asthma Immunol. 1997;79(2):89-90.
  10. Pollock H. Breast capsular contracture. Plast Reconstr Surg. 1997;100(6):1619-1620.
  11. Brown SL, Silverman BG, Berg WA. Rupture of silicone-gel breast implants: Causes, sequelae, and diagnosis. Lancet. 1997;350(9090):1531-1537.
  12. Chung KC, Wilkins EG, Beil RJ Jr, et al. Diagnosis of silicone gel breast implant rupture by ultrasonography. Plast Reconstr Surg. 1996;97(1):104-109.
  13. Egilman DS, Stubbs C. Evaluating the health risks of breast implants. N Engl J Med. 1996;335(15):1154-1156.
  14. Rosenbaum J. The American College of Rheumatology statement on silicone breast implants represents a consensus. Arthritis Rheum. 1996;39(10):1765.
  15. Karns ME, Cullison CA. Breast implants and connective-tissue disease. JAMA. 1996;276(2):101-103.
  16. Mogelvang C. Breast implants. Plast Reconstr Surg. 1995;96(1):236.
  17. Bestler JM. Ruptured breast implant. Plast Reconstr Surg. 1995;96(1):234-235.
  18. Guyen JM, Lairy G, Fleurette F. Silicone gel breast implants [summary]. Paris, France: L'Agence Nationale d'Accreditation d'Evaluation en Sante (ANAES); 1996. 
  19. Health Council of the Netherlands Gezondheidsraad (GR). Health risks of silicone breast implants [summary]. Den Haag, The Netherlands: GR; 1999.
  20. Agencia de Evaluacion de Tecnologias Sanitarias (AETS). Health risks posed by silicone implants in general, with special attention to breast implants (Public report) [summary]. Informe de Evaluacion de Tecnologias Sanitarias No. 23, IPE-00/23. Madrid, Spain: AETS; 2000.
  21. Framarin A. Evaluation of techniques for detecting breast implant rupture. AETMIS 02-01 RE. Montreal, QC: Agence d'Evaluation des Technologies et des Modes d'Intervention en Sante (AETMIS); 2002.
  22. Janowsky EC, Kupper LL, Hulka BS. Meta-analysis of the relation between silicone breast implants and the risk of connective tissue diseases. N Engl J Med. 2000;342(11):781-790.
  23. Symmons DPM. Review: Silicone breast implants do not increase the risk of connective tissue diseases. Evid Based Med. 2000;5:189.
  24. Fischbacher C. Cosmetic breast augmentation. STEER: Succint and Timely Evaluated Evidence Reviews. Bazian Ltd., eds. London, UK: Wessex Institute for Health Research and Development (WIHRD), University of Southampton; 2003;3(1):1-11.
  25. Spear SL, Howard MA, Boehmler JH, et al. The infected or exposed breast implant: Management and treatment strategies. Plast Reconstr Surg. 2004;113(6):1634-1644.
  26. UK National Health Service, Department of Health (DoH). Breast implants. Information for women considering breast implants. London, UK: DoH; 2004. Available at: http://www.dh.gov.uk/assetRoot/04/01/45/74/04014574.pdf. Accessed February 15, 2006.
  27. Tuli R, Flynn RA, Brill KL, et al. Diagnosis, treatment, and management of breast cancer in previously augmented women. Breast J. 2006;12(4):343-348.
  28. Wong CH, Samuel M, Tan BK, Song C. Capsular contracture in subglandular breast augmentation with textured versus smooth breast implants: A systematic review. Plastic Reconstruct Surg. 2006;118(5):1224-1236.
  29. McIntosh SA, Horgan K. Breast cancer following augmentation mammoplasty - a review of its impact on prognosis and management. J Plast Reconstr Aesthet Surg. 2007;60(10):1127-1135.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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