CurrentCignaPolicy 0048

Breast Implant Removal (Medical Coverage Policy)

Defines medical necessity criteria for removal of silicone or saline breast implants, management of the implant capsule (capsulotomy/capsulectomy), and subsequent implantation of a new FDA-approved breast implant; lists indications considered medically necessary, not medically necessary, and coding guidance.

Policy Summary

PayerCigna

PolicyBreast Implant Removal (Medical Coverage Policy)

Policy CodePolicy 0048

Change TypeAnnual review — revised policy statements (4/15/2026)

Effective DateApr 15, 2026

Next Review DateJan 15, 2027

Key ActionDocument imaging confirmation of silicone implant rupture or extrusion (mammography, ultrasound, or MRI) and document clinical indications (e.g., reconstruction association, infection treatment failure, or Baker Grade IV) to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Revised policy statement for removal of either a saline-filled or silicone gel-filled breast implant when associated with breast reconstruction and removal of a silicone gel-filled breast implant when there is a confirmed rupture/extrusion on imaging.

Clarified an indication for removal of implant (annual review note).

9Medically necessary indications listed

9CPT codes referenced

1Material policy change in 2026

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8FDA PMA device references

Coverage Summary

Overview: This policy (effective 4/15/2026, last reviewed 4/15/2026, next review 1/15/2027) defines medical necessity criteria for removal of saline or silicone gel breast implants, management of the implant capsule (capsulotomy/capsulectomy), and conditions under which replacement with a new FDA‑approved implant is considered medically necessary. The policy lists specific covered indications (reconstruction-associated removal, imaging-confirmed silicone rupture/extrusion, interference with cancer care, infection not responsive to medical management, extrusion, Baker Grade IV contracture, tissue necrosis, confirmed BIA‑ALCL or BIA‑SCC, and current use of Allergan BIOCELL textured implants) and specifies numerous exclusions (including cosmetic indications and prophylactic removal of intact implants).

Policy metadata and quick facts

Effective date2026-04-15

Last review2026-04-15

Next review2027-01-15

Policy numberCigna 0048

StatusCURRENT

SubjectBreast implant removal and replacement

Medical Necessity Criteria

Medically Necessary: Removal associated with breast reconstruction following mastectomy or lumpectomy

Removal of EITHER a saline-filled OR silicone gel-filled breast implant and/or surgical management of the implant capsule (including capsulotomy, capsulorrhaphy, partial or complete capsulectomy) when associated with breast reconstruction following mastectomy or lumpectomy is considered medically necessary for ANY indication, including for the purpose of producing a symmetrical appearance of the nondiseased breast.

ALL of the following

Removal of EITHER a saline-filled OR silicone gel-filled breast implant and/or surgical management of the implant capsule (including capsulotomy, capsulorrhaphy, partial or complete capsulectomy) when associated with breast reconstruction following mastectomy or lumpectomy is considered medically necessary for ANY indication, including for the purpose of producing a symmetrical appearance of the nondiseased breast.

Medically Necessary: Removal of ruptured silicone gel-filled implant

The removal of a silicone gel-filled breast implant with or without capsular revision (partial or complete capsulectomy) is considered medically necessary when rupture of the implant and/or extrusion of the implant contents have been confirmed on imaging studies.

ALL of the following

Not Medically Necessary / Cosmetic

The following are considered not medically necessary and/or cosmetic unless associated with breast reconstruction following mastectomy or lumpectomy:

ANY of the following

Removal of an intact silicone gel-filled breast implant when performed solely for suspected autoimmune disease, connective tissue disease, breast implant illness, or breast cancer prevention
Removal of a ruptured saline-filled implant in the absence of one of the medically necessary indications listed above
Rupture/deflation of saline implant alone without other indications is not medically necessary
Removal of any type of breast implant performed solely to treat psychological symptomatology or psychosocial complaints

Coding

Considered Medically Necessary (implant removal / capsulectomy) when criteria metCPTCovered

19328	Removal of intact breast implant
19330	Removal of ruptured breast implant, including implant contents (eg, saline, silicone gel)
19370	Revision of peri-implant capsule, breast, including capsulotomy, capsulorrhaphy, and/or partial capsulectomy
19371	Peri-implant capsulectomy, breast, complete, including removal of all intracapsular contents

Considered Medically Necessary (implant insertion / replacement) when criteria metCPTCovered

19325	Breast augmentation with implant
19342	Insertion or replacement of breast implant on separate day from mastectomy

Considered Not Medically Necessary / Cosmetic (codes listed as not medically necessary unless associated with reconstruction)CPTNot Covered

19316	Mastopexy
19328	Removal of intact breast implant
19330	Removal of ruptured breast implant, including implant contents (eg, saline, silicone gel)
19342	Insertion or replacement of breast implant on separate day from mastectomy

Referenced FDA PMA / device listings (informational)mixed

P990075	Mentor Corporation Saline-filled and Spectrum Breast Implants (PMA)
P120011	Puregraft Serene Breast Implant formerly Ideal Implant Saline-filled Breast Implant (PMA)
P040046	Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-filled Breast Implant (PMA)
P060028	MemoryShape Breast Implants (PMA)
P030053	Mentor MemoryGel Silicone Gel-filled Breast Implants (PMA)
P020056	Allergan Natrelle saline-filled breast implants (PMA)
P990074	Allergan Natrelle Silicone-Filled Breast Implants (PMA)
P070004	Sientra Silicone Gel-Filled Breast Implants (PMA)

Provider Actions & Documentation Requirements

Documentation Required

Imaging confirmation for silicone implant rupture

For removal of a silicone gel–filled implant due to rupture, imaging confirmation (mammography, ultrasound, or MRI) demonstrating rupture and/or extrusion is required to meet medical necessity.

CPT 19330

Documentation Required

Indication documentation for infection or contracture

When removal is being requested for infection or capsular contracture, document failure, contraindication, or intolerance to medical management (including antibiotics) for infection, and document Baker Grade IV when using capsular contracture as the indication.

Affected codes: 19370
Affected codes: 19371

Background and Evidence

Background: Breast implants (saline and silicone gel) differ by shell surface (smooth vs textured), shape, profile and filler and are regulated by the FDA as class III devices under the PMA process. Clinically significant complications that may necessitate explantation include capsular contracture (which can be severe enough to meet Baker Grade IV), infection that fails medical management, implant extrusion or tissue necrosis, rupture of silicone implants with potential extracapsular silicone migration, and interference with cancer diagnosis or treatment.

Oncologic and rare malignancy concerns: rare peri‑implant malignancies such as BIA‑ALCL and BIA‑SCC have been reported; diagnosis and management rely on imaging, cytology/pathology, and en‑bloc capsulectomy with implant removal when confirmed.

Imaging role: MRI can be medically necessary to confirm suspected silicone gel‑filled implant rupture when mammography or ultrasound are inconclusive; imaging confirmation of rupture/extrusion is required by the policy to support removal of silicone gel‑filled implants for rupture.

FDA device and regulation context: the FDA requires updated labeling (including a boxed warning, patient decision checklist, and rupture‑screening recommendations), has issued safety communications about BIA‑ALCL and reports of SCC/various lymphomas in the capsule, and has restricted or recalled certain textured devices (e.g., Allergan BIOCELL) because of lymphoma risk.

Key evidence references

FDA safety communicationsFDA safety communications and labeling updates re: BIA-ALCL and BIA-SCC; FDA does not recommend prophylactic removal in asymptomatic patients

Revision History

4/15/2026material_revisionLatest

Annual Review dated 4/15/2026: Revised policy statements clarifying indications for implant removal, including removal of either a saline-filled or silicone gel-filled breast implant when associated with breast reconstruction and removal of a silicone gel-filled breast implant when there is a confirmed rupture/extrusion on imaging; wording clarifications on removal of intact silicone-gel filled implants and cosmetic exclusions. (Marked as material)

1/15/2025annual_review

Annual Review dated 1/15/2025: Clarified an indication for removal of implant; no prior policy statement changes noted.

1/15/2024annual_review

Policy Summary

PayerCigna

PolicyBreast Implant Removal (Medical Coverage Policy)

Policy CodePolicy 0048

Change TypeAnnual review — revised policy statements (4/15/2026)

Effective DateApr 15, 2026

Next Review DateJan 15, 2027

SourceLink

On This Page

Rupture of silicone gel-filled breast implant and/or extrusion of implant contents has been confirmed on imaging (mammography, ultrasound, or MRI).

Imaging confirmation (mammography, ultrasound, or MRI) is required.

Removal of the silicone gel-filled implant with or without capsular revision (partial or complete capsulectomy) is performed.

Medically Necessary: Removal for other specified indications

The removal of EITHER a silicone gel-filled OR saline-filled breast implant, with or without capsular revision (partial or complete capsulectomy), is considered medically necessary for at least ONE of the following indications:

ANY of the following

The implant is interfering with diagnostic evaluation of a suspected breast cancer.
The implant is interfering with adequate treatment of known breast cancer (e.g., obstructing radiation therapy).
Acute, persistent, or recurrent local or systemic infection secondary to a breast implant when there is failure, contraindication, or intolerance to medical management, including antibiotics.
Current exposure of a breast implant (implant extrusion).
Baker Grade IV capsular contracture.
Tissue necrosis secondary to the implant.
Confirmed diagnosis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Current use of Allergan BIOCELL textured breast implants and tissue expanders.
Confirmed diagnosis of breast implant-associated squamous cell carcinoma (BIA-SCC).

Medically Necessary Removal Criteria (excerpts and clarifications reflected in revision)

Following removal of a breast implant, the subsequent surgical implantation of a new U.S. Food and Drug Administration (FDA)-approved breast implant is considered medically necessary when criteria below are met. Replacement of an implant after removal is considered medically necessary only when associated with breast reconstruction following mastectomy or lumpectomy, or for creation of symmetry as described.

ANY of the following

Breast reconstruction of a diseased or affected breast following mastectomy or lumpectomy.
Creation of a symmetrical appearance in the contralateral/nondiseased breast following mastectomy or lumpectomy in the opposite breast.
Replacement of an implant following removal is NOT medically necessary when performed solely for cosmetic reasons or for indications listed as not medically necessary (e.g., solely to treat psychological symptomatology, solely to improve appearance, solely because of shifting or migration of the implant, mastopexy following implant removal) unless associated with breast reconstruction following mastectomy or lumpectomy.

Removal performed solely to improve appearance

Removal performed solely because of shifting or migration of the implant (in absence of other signs/symptoms such as significant capsular contracture, persistent infection, or silicone rupture)

Removal of the implant in the opposite/contralateral breast, unless criteria are otherwise met for that breast implant

Replacement of an implant following removal (i.e., replacement is considered not medically necessary/cosmetic unless associated with reconstruction following mastectomy or lumpectomy)

Mastopexy following implant removal (considered not medically necessary/cosmetic unless associated with reconstruction following mastectomy or lumpectomy)

Any other indication not otherwise mentioned above as covered

Definitions summary: key terms used in the policy include the Baker grading system for capsular contracture (with Baker Grade IV indicating severe, painful, hard, misshapen breasts), BIA‑ALCL (breast implant–associated anaplastic large cell lymphoma, a rare non‑Hodgkin lymphoma associated with implants), BIA‑SCC (breast implant–associated squamous cell carcinoma, a rare peri‑implant malignancy), and Rupture/Extrusion (imaging‑confirmed) (rupture of the implant and/or extrusion of implant contents demonstrated on mammography, ultrasound, or MRI required to support certain coverage for silicone implant removal).

Regulatory and prophylactic removal guidance: per FDA safety communications and labeling updates, the FDA does not recommend prophylactic removal of breast implants in asymptomatic patients solely due to concerns about developing BIA‑ALCL, BIA‑SCC, or other lymphomas; implant removal is generally reserved for patients with signs or symptoms or imaging/pathology confirmation.

Affected codes: 19328

Affected codes: 19330

Billing Rule

Use appropriate covered diagnosis/procedure codes

Providers must use the most appropriate diagnosis and procedure codes as of the date of service; claims for services not accompanied by covered codes under this policy will be denied as not covered.

19325
19328
19330
19342
19370
19371
19316

Documentation Required

Imaging confirmation for rupture/extrusion

Document imaging evidence (e.g., mammography, ultrasound, or MRI) demonstrating rupture and/or extrusion to support medical necessity for removal of silicone gel–filled implants. Absence of imaging confirmation risks denial of the claim.

Documentation Required

Associate removal with reconstruction

When claiming removal under the reconstruction-associated indication, document that the implant removal and any capsular procedure are associated with breast reconstruction following mastectomy or lumpectomy.

Systematic review on BII (Trabilsy et al., 2025)Reviewed 48 studies: 49% reported BII-associated symptoms; methodological limitations; some symptom improvement/resolution after explantation reported

Key FDA PMA/device listingsExamples: Mentor P990075; Puregraft P120011; Natrelle P040046/P020056; MemoryGel P030053; Sientra P070004 (listed as informational)

PROFILE Registry and reportingPROFILE Registry and FDA case reporting recommended for BIA-ALCL cases

FDA safety communication (2022/2023)Reports of SCC and various lymphomas in peri-implant capsule; rare; FDA advises against prophylactic removal in asymptomatic patients

Baker Grade IV: severe capsular contracture producing a hard, misshapen, tender and painful breast; Baker Grade IV contracture is a listed medically necessary indication for implant removal and/or capsulectomy.

BIA‑ALCL: breast implant‑associated anaplastic large cell lymphoma is a rare non‑Hodgkin lymphoma linked to implants; typical presentation includes delayed swelling, seroma, mass or pain around the implant and diagnosis requires cytology/pathology (CD30 positive) and is managed with explantation and total capsulectomy.

BIA‑SCC: breast implant‑associated squamous cell carcinoma is a very rare peri‑implant malignancy reported in the capsule; presentation can mirror BIA‑ALCL (delayed seroma, mass, contracture) and standard treatment reported is explantation with en‑bloc capsulectomy.

Rupture/Extrusion (imaging‑confirmed): evidence on imaging (mammography, ultrasound, or MRI) demonstrating implant rupture and/or extrusion of implant contents; required documentation to support removal of silicone gel‑filled implants for rupture/extrusion.

Annual Review dated 1/15/2024: No changes to policy statement.