Reconstructive breast surgery is defined as surgical procedures that are designed to restore the normal appearance of the breast after surgery, accidental injury, or trauma. The most common indication for reconstructive breast surgery is a prior mastectomy; in fact, benefits for reconstructive breast surgery in these patients are a mandated benefit in many states. In contrast, cosmetic breast surgery is defined as surgery designed to alter or enhance the appearance of a breast that has not undergone surgery, accidental injury, or trauma. Reduction mammoplasty is a common example of cosmetic breast surgery, but surgery to alter the appearance of a congenital abnormality of the breasts, such as tubular breasts, would also be considered cosmetic in nature.

The most common type of reconstructive breast surgery is insertion of a silicone gel-filled or saline-filled breast implant, either inserted immediately at the time of mastectomy (CPT code 19340) or sometime afterward in conjunction with the previous use of a tissue expander (19342, 19357). Local complications of breast implants are frequent and may require removal of the implant. Contracture is the most common local complication of breast implants. Contractures have been graded according to the Baker classification as follows:

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

Other types of reconstruction include nipple/areola reconstruction, nipple tattooing, and/or the use of autologous tissue, such as a transverse rectus abdominus myocutaneous flap (TRAM procedure) or a latissimus dorsi flap. In addition, mastopexy or reduction mammoplasty on the contralateral breast may be performed to achieve symmetry with the reconstructed breast.

The following policy describes different types of reconstructive breast surgery and establishes criteria for the explantation of breast implants based on whether the original implant was cosmetic or reconstructive in nature, and whether the implant is silicone gel-filled or saline-filled. Please see Rationale/Source section for further discussion.

Coverage eligibility of breast implants for the purposes of augmentation may depend on contract language. After reconstructive breast surgery on one side, insertion of an implant on the contralateral, normal side is rarely necessary to achieve symmetry.

Reconstructive breast surgery may be considered medically necessary after a medically necessary mastectomy, accidental injury, or trauma. Medically necessary mastectomies are most typically done as treatment for cancer.

Explantation of a silicone gel-filled breast implant may be considered medically necessary in all cases for a documented implant rupture, infection, extrusion, Baker class IV contracture, or surgical treatment of breast cancer.

Explantation of a ruptured saline- filled breast implant may be considered medically necessary only in those patients who had originally undergone breast implantation for reconstructive purposes. Otherwise, indications for the explantation of a saline-filled implant are similar to those of a silicone-filled implant.

Explantation of a breast implant associated with a Baker class III contracture may be considered medically necessary only in those patients who had originally undergone breast implantation for reconstructive purposes.

Reconstructive breast surgery after explantation of an implant is considered medically necessary only in those patients who had originally undergone breast implantation for reconstructive purposes.

The following indications for explantation of implants are considered not medically necessary:

• Systemic symptoms, attributed to connective tissue diseases, autoimmune diseases, etc.;
• Patient anxiety;
• Baker class III contractures in patients with implants for cosmetic purposes;
• Rupture of a saline implant in patients with implants for cosmetic purposes;
• Pain not related to contractures or rupture.

Application of the above policy regarding explantation of implants requires documentation of the original indication for implantation and the type of implant, either saline- or silicone gel-filled, and the current symptoms, either local or systemic. The following chart should facilitate determination of the medical necessity of explantation. Yes indicates that the explantation would be considered medically necessary, given the symptoms, type of implant, and original indication for implantation.

Indication/Type of Implant

*Rupture of implants requires documentation with an imaging study, such as mammography, magnetic resonance imaging, or ultrasonography. Lack of imaging confirmation of rupture in association with persistent local symptoms requires case by case consideration.

** Pain as an isolated symptom is an inadequate indication for explantation. The pain should be related to the Baker classification or a diagnosis of rupture.

Reconstructive breast surgery may consist of any of the following procedures (see also CPT codes, below):

• Immediate or delayed insertion of breast prosthesis with or without associated tissue expansion;
• Autologous reconstruction using autologous tissue, e.g., latissimus dorsi flap, transverse rectus abdominis myocutaneous flap, or free flap;
• Revision of reconstructed breast;
• Nipple/areola reconstruction and nipple tattooing when the breast reconstruction is considered eligible for coverage;
• Mastopexy or reduction mammoplasty on the contralateral breast to achieve symmetry.

BlueCard/National Account Issues

Implementation of the above policy regarding explantation of breast implants requires documentation of the original indication for implantation, the type of implant used (either silicone gel-filled or saline), and the symptoms prompting explantation.

According to some contract language, removal of a cosmetic implant may be considered a complication of a non-covered procedure and thus is not eligible for coverage.

It is anticipated that a minority of requests for implant explantation will meet the above criteria, since many explantations are performed due to anxiety on the part of the patient. Therefore, plans should consider adding the CPT codes for explantation (19328, 19330) to their prior approval/precertification lists.

Reconstructive breast surgery is considered medically necessary after a medically necessary mastectomy or after accidental trauma or injury. The most common type of reconstruction is insertion of a breast implant, either a silicone gel-filled or saline-filled prosthesis. The breast may also be reconstructed using autologous tissues, such as a free flap (19364), a latissimus dorsi flap (19361), or more commonly using a transverse rectus abdominis flap (TRAM procedure, 19367, 19369). Nipple areola reconstruction (19350) or nipple tattooing (11920) may also be considered reconstructive breast surgery. Since the purpose of reconstructive breast surgery is to restore the normal appearance of the breast, on some occasions procedures are performed on the contralateral, normal breast to achieve symmetry, such as mastopexy (19316) and reduction mammoplasty (19318). These procedures fall into the category of reconstructive breast surgery only when performed in conjunction with a contralateral mastectomy for cancer with associated reconstruction. Except for medically necessary reduction mammoplasty, these procedures are considered cosmetic in other circumstances.

Complications of breast implants are common and may require explantation. (1) Determining the medical necessity of explantation requires documentation of the type of implant and its original indication, i.e., whether reconstructive or cosmetic. The basic underlying principle is that cosmetic implants require explantation only for absolute medical indications that pose significant health consequences, while the criteria for explantation of reconstructive implants are broader. Since the purpose of reconstructive implants is the restoration of normal breast appearance, in a small subset of patients explantation may be warranted in cases of unsatisfactory aesthetic outcome.

Complications can be subdivided into local or systemic complications. Local complications include implant contracture, rupture, extrusion, or infection. Extrusion or infection are considered absolute medical indications for explantation in all cases, whether the implant was originally cosmetic or not. Documented rupture of a silicone gel–filled implant is considered an absolute indication for explantation in all cases. However, explantation of a ruptured saline implant is considered medically necessary only in the setting of prior reconstruction. Since normal saline is physiologic, rupture poses no health threat, and thus explantation would not be considered medically necessary in patients with cosmetic implants. However, a ruptured saline implant compromises the aesthetic outcome and thus explantation may be considered appropriate in cases of reconstructive implants.

Rupture of the breast implant may be difficult to document, but physical exam, mammography, ultrasonography, or magnetic resonance imaging has been used. There is no consensus on which method affords the best sensitivity and specificity. (2-4) Although it has been suggested that older implants are associated with a higher incidence of rupture, there is no consensus that screening implants for rupture is warranted. Specifically, in the hearings on breast implants by the U.S. Food and Drug Administration (FDA), held in 1992, the FDA did not recommend screening for asymptomatic ruptures. Instead, work-up for a potential rupture is typically initiated at the onset of local symptoms, such as sudden change in the size or consistency of an implant, or the development of local pain.

Contracture is a more subjective finding, which is graded according to the Baker classification. (5) Baker classification ranges from Grade I, describing a normal implant, to Grade IV, which describes an implant that is hard, cold, painful, tender, and distorted. Grade IV contractures interfere with adequate mammography screening, and thus their presence constitutes a health risk. (6) Therefore, explantation may be considered medically necessary in all cases, regardless of whether the implant was originally inserted for cosmetic or reconstructive purposes. Grade III contractures, which describe firm, palpable implants, do not interfere with mammography; therefore, explantation of these implants is not considered an absolute indication for explantation. However, since Grade III contractures have an impact on the normal appearance of the breast, explantation may be appropriate in implants inserted for reconstructive purposes, since the goal of restoration of the normal appearance of the breast is not achieved.

Potential systemic complications of implants, most prominently various connective tissue diseases or chronic fatigue syndrome, have been hotly debated for the past 5 years. In particular, it has been hypothesized that leakage of silicone, due either to an implant rupture or to “bleeding” of silicone through an intact capsule, may incite an autoimmune response with the development of systemic symptoms. However, to date, large epidemiologic studies have not demonstrated that women with breast implants are overrepresented among all those with connective tissue disease. (7-10) In addition, there are inadequate empiric studies to demonstrate that removal of breast implants is associated with resolution of systemic symptoms.

Patients with cosmetic implants may develop breast cancer. While lumpectomy can be accomplished without removal of the implant, in general, explantation as an adjunct to surgical treatment for breast cancer would be considered medically necessary. However, explantation is not necessary in patients who are undergoing chemotherapy or radiation therapy for breast cancer.

Once an implant has been removed, patients who have originally undergone reconstructive implantation are candidates for additional reconstructive breast surgery, either insertion of another breast implant, or for autologous reconstruction of the breast, as described above. Patients who have originally undergone implantation of a cosmetic breast implant are not candidates for additional reconstructive breast surgery after explantation.

References:

1. Gabriel SE, Woods JE, O’Fallon WM et al. Complications leading to surgery after breast implantation. N Engl J Med 1997; 336(10):677-82.
2. Samuels JB, Rohrich RJ, Weatherall PT et al. Radiographic diagnosis of breast implant rupture: current status and comparison of techniques. Plast Reconstr Surg 1995; 96(4):865-77.
3. Netscher DT, Weizer G, Malone RS et al. Diagnostic value of clinical examination and various imaging techniques for breast implant rupture as determined in 81 patients having implant removal. South Med J 1996; 89(4):397-404.
4. Chung KC, Wilkins EG, Beil RJ Jr. et al. Diagnosis of silicone gel breast implant rupture by ultrasonography. Plast Reconstr Surg 1996; 97(1):104-9.
5. Baker JL. Augmentation mammoplasty. In: Symposium on Aesthetic Surgery of the Breast. Owsley JQ, Peterson RA (eds). St. Louis: Mosby, 1978.
6. 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.
7. Gabriel SE, O’Fallon WM, Kurland LT et al. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 1994; 330(24):1697-702.
8. Hennekens CH, Lee IM, Cook NR et al. Self-reported breast implants and connective-tissue disease in female health professionals. A retrospective cohort study. JAMA 1996; 275(8):616-21.
9. Sanchez-Guerrero J, Colditz GA, Karlson EW et al. Silicone breast implants and the risk of connective-tissue disease and symptoms. N Eng J Med 1995; 332(25):1666-70.
10. Silverman BG, Brown SL, Bright RA et al. Reported complications of silicone gel breast implants: an epidemiologic review. Ann Intern Med 1996; 124(8):744-56.

Source:

A search of the literature was completed through the MEDLINE database from January 1994 through May 1997. The search strategy focused on references containing the following words:

– Breast implants

Breast implants, removal
Breast reconstruction surgery
Contractures, breast implant
Implants, removal from breast
Latissimus dorsi flap
Reconstruction, breast
Removal of breast implants
Rupture, breast implant
TRAM procedure
Transverse rectus abdominis myocutaneous flap