Reconstructive breast surgery refers to surgical procedures to rebuild the contour of the breast, along with the nipple and areola if desired. Typically, breast reconstruction is performed following a mastectomy (i.e., the breast has been removed because of breast cancer) or lumpectomy (i.e., removal of the breast tumor and tissue surrounding it), but occasionally techniques of breast reconstruction are used to treat individuals who have an abnormal development of one or both breasts. 

This document addresses the following three areas: reconstructive breast surgery, cosmetic surgeries designed to enhance the appearance of the breast and management of breast implants.  

Note: Please see the following related document(s) for additional information: 

• SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting;
• SURG.00086 Reduction Mammaplasty.

Note: The Women's Health and Cancer Rights Act of 1998 (WHCRA) is federal legislation that provides that any individual, with insurance coverage who is receiving benefits in connection with a mastectomy covered by their benefit plan (whether or not for cancer) who elects breast reconstruction, must receive coverage for the reconstructive services as provided by WHCRA.  This includes reconstruction of the breast on which the mastectomy has been performed, surgery and reconstruction of the other breast to produce a symmetrical appearance and prostheses and treatment of physical complications of all stages of the mastectomy including lymphedemas. If additional surgery is required for either breast for treatment of physical complications of the implant or reconstruction, surgery on the other breast to produce a symmetrical appearance is reconstructive at that point as well.  The name of this law is misleading because: 1) cancer does not have to be the reason for the mastectomy; and 2) the mandate applies to men, as well as women.  WHCRA does not address lumpectomies.  Some states have enacted similar legislation, and some states include mandated benefits for reconstructive services after lumpectomy. 

Medically Necessary:  In this document, procedures are considered medically necessary if there is a significant physical functional impairment, AND the procedure can be reasonably expected to improve the physical functional impairment.

Reconstructive:  In this document, procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or congenital defect.
NOTE:  Not all benefit contracts include benefits for reconstructive services as defined by this document. Benefit language supersedes this document.

Cosmetic:  In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those that are primarily intended to preserve or improve appearance.

Medically Necessary:

Removal of implants partially or completely filled with Silicone Gel is considered medically necessary when there is documented implant rupture (i.e., using mammography, ultrasound, or MRI).

Removal of a Silicone Gel filled, Saline filled or "Alternative" implant is considered medically necessary for any of the following:

• Infection of the implant or surrounding tissue; or
• Implant exposure/extrusion; or
• Pain related to Baker Class IV capsular contracture; or
• Prior to surgical treatment of breast cancer. (Note: Implant explantation is routinely performed at the time of mastectomy. In individuals treated with breast conserving surgery [i.e., lumpectomy], a breast implant may or may not interfere with subsequent treatment, and thus explantation at the time of lumpectomy is at the discretion of the treating physician and the treated individual.)

Reconstructive: 

Breast surgery to rebuild the normal contour of the affected and the contralateral unaffected breast to produce a more normal appearance, is considered reconstructive, following a mastectomy, lumpectomy, or other breast surgery to treat breast cancer. The number of procedures and timing of these procedures varies, depending on the individualized treatment plan devised by the treating physician(s) and the individual and may be impacted by the overall treatment plan for the breast cancer itself.

Covered reconstructive procedures include any or all of the following:

1. Reconstructive surgery and implant insertion;
2. Procedures where muscle tissue is transposed from another site;
3. Reconstruction of the contralateral breast to achieve symmetry with reduction mammaplasty, augmentation mammaplasty with implants, or mastopexy;
4. Revision or removal of pre-existing breast implants placed for cosmetic purposes.

Breast surgery of both breasts is considered reconstructive following the mastectomy of both breasts.

Breast surgery to alter the contour of the breast is considered reconstructive when there are significant abnormalities related to trauma, congenital defects, infection or other non-malignant disease.  A specific example of this is Poland's syndrome which may be diagnosed when all of the following are present:

• Congenital absence or hypoplasia of pectoralis major and minor muscles; and
• Breast hypoplasia; and
• Congenital partial absence of the upper costal cartilage.

Removal of an implant (any type) with or without reimplantation is considered reconstructive when an implant, originally placed in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer for reconstructive purposes as defined above, develops a visible distortion (Baker Class III contracture).  

Removal of a saline-filled or "Alternative" implant with or without reimplantation is considered reconstructive when originally placed in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer for reconstructive purposes, as defined above, if it ruptures.

Surgery on the contralateral breast to produce a symmetrical appearance after removal of an implant and reimplantation is considered reconstructive when the implant was originally placed for reconstructive purposes in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer.

Not Medically Necessary:

Removal of a ruptured saline-filled or "Alternative" implant is considered not medically necessary since the potential adverse medical consequences of implant rupture are related to silicone gel implants only.

Removal of ANY type of breast implant is considered not medically necessary for any of the following:

• Systemic symptoms attributed to connective tissue disease, autoimmune diseases, etc; or
• Personal anxiety; or
• Pain not related to contractures or rupture; or
• The medically necessary or reconstructive criteria listed above have not been met.

Cosmetic and Not Medically Necessary:

Reimplantation of an implant inserted for cosmetic purposes only (i.e., for reasons other than a history of mastectomy, lumpectomy, treatment of breast cancer, significant abnormalities related to trauma, congenital defects, infection or other non-malignant disease) and removed as part of a medically necessary or reconstructive surgery (see above) is considered cosmetic and not medically necessary. 

Other breast procedures, (including augmentation mammaplasty/breast lift, implant repositioning, repair of inverted nipples, mastopexy) are considered cosmetic and not medically necessary except when performed as part of a covered breast reconstruction service.

The Women's Health and Cancer Rights Act of 1998 (WHCRA) mandated that reconstructive breast surgery for women and men who have undergone mastectomy be covered by their benefits for those who have opted to have breast reconstruction.  In individuals who have undergone a medically necessary lumpectomy, surgery to create a more normal anatomy is considered reconstructive.    

Removal of silicone-filled implants has been shown to be necessary when due to infection, implant exposure, or pain related to capsular contracture.  In addition, Grade IV contractures interfere with adequate mammography screening and thus, their presence has potential medical implications. Therefore, removal may be considered medically necessary.  Grade III contractures do not interfere with mammography; therefore, Grade III contractures are not considered an absolute indication for removal.  However, since Grade III contractures do have an impact on the normal appearance of the breast, removal may be appropriate for implants originally placed for reconstructive purposes, since the goal of restoration of the normal appearance of the breast is not achieved. Contracture is the most common local complication of breast implants. Contractures have been graded according to the Baker Classification which is outlined below:

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

The FDA labeling of silicone implants recommends removal of ruptured silicone implants.  Intact silicone implants are all associated with leakage of small amounts of silicone, and there has been concern that this leakage is associated with various autoimmune diseases.  The data from multiple studies is inadequate to support an association between silicone implants and autoimmune disease (Janowsky, 2000). 

In 2011, the FDA published preliminary findings and analyses of anaplastic large cell lymphoma (ALCL) in women with breast implants. As part of its analysis, the FDA conducted a thorough review of scientific literature published from January 1997 through May 2010.  From this review, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world.  In total, the FDA is aware of approximately 60 case reports of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature. Some cases have been identified through the FDA's contact with other regulatory authorities, scientific experts, and breast implant manufacturers, and it is not clear how many of these are duplicates of the ones found in the literature. The number of identified cases is small compared to the estimated 5-10 million women who have received breast implants worldwide.  Based on these data, "The FDA believes that women with breast implants may have a very small but increased risk of ALCL.  Because the risk of ALCL appears very small, FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled." (FDA, 2011; Kim, 2011).

In the case of saline-filled implants, infection, implant exposure, or pain related to capsular contracture requires implant removal.  Ruptured saline-filled implants have not been shown to pose any health risks due to the physiologic nature of saline, and their removal does not meet medical necessity criteria.

There is no medical evidence that supports the removal of breast implants for systemic symptoms, anxiety, or pain not related to contractures or rupture.  The placement or removal of an implant in a healthy woman is not considered to have any medically necessary justification and is considered cosmetic.

Note: Before considering the medical necessity for the removal of breast implants, the following questions must be answered:

1. Was the original insertion of breast implant(s) considered reconstructive or cosmetic in nature? 
   Removal of a breast implant is considered reconstructive if the breast implant, originally inserted for reconstructive purposes, is associated with a significantly altered appearance, such that the goals of reconstruction (i.e., to return the individual to a whole) are not reached.
2. What signs or symptoms are present?
   The presence of signs and symptoms related to the breast implant (for example, painful capsular contracture or rupture) may be used to establish the medical necessity for implant removal. Certain signs or symptoms (see medical necessity criteria) will establish the medical necessity of implant removal, regardless of whether the implant was originally implanted for reconstructive or cosmetic reasons.
3. What type of implant is being removed?
   The medical necessity criteria for explantation may depend on the type of implant. For example, the medical consequences of rupture of a silicone gel-filled implant differ from rupture of a saline-filled implant. The following implants are available:
   • Silicone gel-filled;
   • Saline-filled;
   • Combination implants, i.e., double lumen implants, consisting of an inner silicone-gel filled lumen surrounded by a saline-filled lumen.

Description of Technology

Reconstructive breast surgery is a surgical procedure that is designed to restore the normal appearance of a breast after a medically necessary mastectomy or other medical condition, injury or congenital abnormality.  In contrast, cosmetic breast surgery is defined as surgery designed to alter or enhance the appearance of a breast that has not undergone a medically necessary surgery, an accidental injury, or trauma.

Breast reconstruction following a mastectomy can be done immediately after or some time following a procedure to remove a breast.  In an immediate procedure, after removal of the breast tissue, the surgeon will place a breast implant in the location where the breast was removed.  This is referred to as a one-stage procedure and has no impact on the outcome of any chemotherapy treatments.  A delayed reconstruction procedure may be necessary if radiation therapy following the surgery is needed, since implants may interfere with such treatment.  In some circumstances, it is necessary to do a two-stage procedure, which involves the placement of a tissue expander to stretch the skin where an implant will be inserted.  Placement of the expander will be followed several months later by placement of an implant.  This type of procedure may be done either immediately or some time after the breast removal surgery.  Regardless of which procedure is done, the reconstruction will not interfere with the doctor's ability to detect any disease recurrence.

Another technique used in breast reconstruction involves a two-phase procedure. In the first phase, the breast mound is created, using either an implant with or without a tissue expander, or an autologous tissue reconstruction procedure with a transverse rectus abdominus musculocutaneous flap (i.e., TRAM flap), and allowed to heal. In the second phase, which begins three to six months after the first stage is completed, the breast shape is refined and the nipple-areola is created. Tattooing of the nipple and/or areola is the final stage of reconstruction, and in some cases may be delayed up to two years.

Alternative breast implants (also called combination implants):  A type of breast implant that has two compartments that contain both silicone and saline.  Some of these implants have silicone as the inner compartment and saline as the outer compartment. The saline compartment is filled at the time of surgery. Other implants in this category contain saline in the inner compartment and silicone in the outer compartment. 

Augmentation mammaplasty (also referred to as augmentation mammoplasty):  A surgical procedure in which the purpose is to enlarge the breast or breasts.

Contracture:  A condition where scar tissue forms internally around the breast implant, tightens and makes the breast round, firm, and possibly painful.  This excessive firmness of the breasts can occur soon after surgery or years later.

Contralateral:  Pertaining to the opposite side which, in the case of breasts, refers to the breast not being medically treated.

Extrusion:  A condition, where the lack of adequate tissue coverage, infection, or other conditions where skin may be weakened, results in exposure of the implant through the skin.

Mastectomy:  The surgical removal of a breast.

Mastopexy:  A surgical procedure designed to elevate sagging breasts to a normal position, often with some improvement in shape.

Poland's Syndrome:  A condition where an individual is born missing some of their chest muscles and cartilage and did not develop a breast on one side of the chest during puberty.

Prophylactic mastectomy:  A surgical procedure to remove a breast or both breasts with the purpose of reducing the risk of breast cancer in women determined to be at intermediate or high risk for developing breast cancer.

Reconstructive breast surgery:  Surgical procedures performed to correct or repair abnormal structures of the breast that are designed to restore the normal appearance of one or both breasts.

Reduction mammaplasty (also referred to as reduction mammoplasty):  A surgical procedure to decrease breast size.

Rupture:  A condition where a liquid or gel-filled breast implant bursts, allowing leakage of its contents into the surrounding tissue.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Reconstructive Breast Procedures following Breast Surgery
When services may be Reconstructive when criteria are met: 

Reconstructive Breast Procedures for Other Indications:
When services may also be Reconstructive when criteria are met:
For the procedure codes listed above; for the following diagnoses:

When services are Cosmetic and Not Medically Necessary:
For the procedures listed above, when criteria not met, or when the code describes a procedure indicated in the Position Statement section as cosmetic and not medically necessary.

Breast Implant Removal or Revision 
When services may be Medically Necessary or Reconstructive when criteria are met: 

When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met, for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as not medically necessary.

Peer Reviewed Publications:

1. Brown SL, Pennello G, Berg WA, et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol. 2001; 28(5):996–1003.Contant CM, Menke-Pluijmers MB, Seynaeve C, et al. Clinical experience of prophylactic mastectomy followed by immediate breast reconstruction in women with hereditary risk of breast cancer (HB(O)C) or a proven BRCA1 and BRCA2 germ-line mutation. Eur J Surg Oncology. 2002; 28:627-632.
2. Diana M, Robb GL, Talavera F, et al.  Breast Reconstruction: Nipple-Areola Reconstruction. Updated July 15, 2011. Available at: http://www.emedicine.com/plastic/topic144.htm.  Accessed on July 12, 2012.
3. Deutsch MF, Robb GL, Talavera F, et al.  Breast Reconstruction:  Free Flap Breast Reconstruction. Updated May 2, 2011.  Available at: http://www.emedicine.com/plastic/topic140.htm.  Accessed on July 12, 2012.
4. Gabriel SE, Woods JE, O'Fallon WM, et al. Complications leading to surgery after breast implantation. N Engl J Med. 1997; 336:677-682.
5. Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective tissue diseases in female health professionals.  A retrospective cohort study.  JAMA. 1996; 275(8):616-621.
6. Henriksen TF, Fryzek JP, Holmich LR, et al. Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors.  Ann Plast Surg. 2005; 54(4):343-351.
7. Holmich LR, Fryzek JP, Kjoller K, et al. The diagnosis of silicone breast implant rupture: clinical findings compared with findings at magnetic resonance imaging.  Ann Plast Surg. 2005; 54(6):583-589.
8. Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Eng J Med. 2000; 342:781-790.
9. Kim B, Roth C, Chung KC, et al.  Anaplastic large cell lymphoma and breast implants: a systematic review.  Plast Reconstr Surg. 2011; 127(6):2141-2150.
10. Lipworth L, Tarone RE, McLaughlin JK. Breast implants and fibromyalgia: a review of the epidemiologic evidence. Ann Plast Surg. 2004; 52(3):284-287.
11. Mathes SJ. Breast implantation: The quest for safety and quality, NEJM. 1997; 336(10):718-719.
12. McLaughlin JK, Lipworth L, Murphy DK, Walker PS. The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence. Ann Plast Surg. 2007; 59(5):569-580.
13. 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.
14. Song JW, Kim HM, Bellfi LT, Chung KC.  The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis.  Plast Reconstr Surg. 2011; 127(3):1029-1044.
15. Weiss PR. Breast reconstruction after mastectomy. Am J Managed Care. 1997; 3(6):932-937.
16. Zion SM, Slezak JM, Sellers TA, et al. Re-operations after prophylactic mastectomy with or without implant reconstruction. Cancer. 2003; 98(10):2152-2160.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Society of Plastic and Reconstructive Surgeons Citizens' Petition to the Food and Drug Administration submitted by the American Society of Plastic and Reconstructive Surgeons which requests that silicone gel-filled implants remain available because the device is necessary for the public health. Nov. 29, 1991. Arlington Heights, Ill.
2. American Society of Plastic Surgeons (ASPS).  Practice parameter:  Treatment Principles of Silicone Breast Implants.  March 2005.  Available at:  http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/evidence-practice/TreatmentPrinciplesofSiliconeBreastImplants.pdf.  Accessed on July 12, 2012.
3. American Society of Plastic Surgeons (ASPS). Breast augmentation in teenagers. Policy statement. Approved December 2004.  Available at:  http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/key-issues/Policy-Statement-on-Breast-Augmentation-in-Teenagers.pdf.   Accessed on July 12, 2012.   
4. Baker JL. Augmentation mammaplasty. In Owsley JG, Peterson RA, eds: Symposium on Aesthetic Surgery of the Breast. St. Louis: Mosby, 1978.
5. Centers for Medicare and Medicaid Services. National Coverage Determination for Breast Reconstruction Following Mastectomy. NCD #140.2. Effective January 1, 1997; revised October 3, 2003. Available at:    http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=64&ncdver=1&bc=AgAAQAAAAAAA&. Accessed on July 12, 2012.
6. National Cancer Institute.  Women with silicone breast implants have no increased risk of death from most causes.  April 27, 2001. Available at: http://www.cancer.gov/newscenter/silicone-mortality.  Accessed on July 12, 2012.
7. NCCN Clinical Practice Guidelines in Oncology™. © 2012. National Comprehensive Cancer Network Clinical Practice guidelines in Oncology.  For additional information visit the NCCN website: http://www.nccn.org/index.asp.   Accessed on July 12, 2012.
   • Breast Cancer (V1.2012).  Revised January 20, 2012.
8. The Women's Health and Cancer Rights Act (WHCRA), §713; October 21, 1998. Available at:  http://www.cms.gov/HealthInsReformforConsume/Downloads/WHCRA_Statute.pdf.  Accessed on July 12, 2012.
9. U.S. Food and Drug Administration (FDA).  Regulatory History of Breast Implants in the U.S.  Available at:  http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064461.htm.  Accessed on July 12, 2012. 
10. U.S. Food and Drug Administration (FDA).  Study of silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women.  Published in May 2001.  Page last updated May 2009.  Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064382.htm.  Accessed on July 12, 2012
11. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH).  Update on the Safety of Silicone Gel-Filled Breast Implants. June 2011.  Available at:  http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf.  Accessed on July 12, 2012.
12. U.S. Food and Drug Administration (FDA).  Guidance for industry: Saline, Silicone Gel, and Alternative Breast Implants.  November 17, 2006.  Available at:  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071228.htm.  Accessed on July 12, 2012.
13. U.S. Food and Drug Administration (FDA).  Center for Devices and Radiological Health (CDRH).  Executive Summary:  Silicone Gel-Filled Breast Implants General Issues Panel.  August 30-31, 2011.  Available at:  http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM269639.pdf.  Accessed on July 12, 2012.
14. U.S. Food and Drug Administration (FDA). Labeling for Approved Breast Implants. Updated March 9, 2012.  Available at:   http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063743.htm.  Accessed on July 12, 2012.
15. U.S. Food and Drug Administration (FDA).  Information on Breast Implants and Anaplastic Large B-cell Lymphoma.  June 22, 2011.  Available at:  http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm.  Accessed on July 12, 2012.

1. American Cancer Society (web site).  Information regarding the Women's Health and Cancer Rights Act.  Available at: http://www.dol.gov/ebsa/publications/whcra.html.  Accessed on July 12, 2012.
2. American Cancer Society:  Breast Reconstruction after Mastectomy.  Updated September 1, 2009.  Available at:  http://www.cancer.org/Cancer/BreastCancer/MoreInformation/BreastReconstructionAfterMastectomy/index.  Accessed on July 12, 2012.
3. American Cancer Society: Information and Resources for Cancer.  Available at: http://www.cancer.org/Search/index?QueryText=breast+cancer&x=50&y=23.  Accessed on July 12, 2012.
4. American Society of Plastic Surgeons (ASPS). Breast Implants.  Available at:   http://www.surgery.org/consumers/procedures/breast/breast-implants.  Accessed on July 12, 2012.
5. American Society of Plastic Surgeons: Breast reconstruction.  Available at: http://www.plasticsurgery.org/Patients_and_Consumers/Procedures/Reconstructive_Procedures/Breast_Reconstruction.html.  Accessed on July 12, 2012.
6. National Cancer Institute: Breast cancer.  Available at: http://www.cancer.gov/cancertopics/types/breast.  Accessed on July 12, 2012.
7. National Library of Medicine. Medical Encyclopedia. Mastectomy.  Available at:   http://www.nlm.nih.gov/medlineplus/mastectomy.html.  Accessed on July 12, 2012.
8. National Library of Medicine. Breast Reconstruction. Updated May 28, 2011. Available at: http://www.nlm.nih.gov/medlineplus/breastreconstruction.html.  Accessed on July 12, 2012.

Augmentation Mammaplasty
Breast Implants
Breast Lift
Breast Procedures
Mammoplasty
Mastopexy
Reconstructive Breast Surgery