{"entity":{"id":"external-breast-prostheses","kind":"technology","name":"External breast prostheses, mastectomy bras and nipple prostheses","aka":["Breast form","Breast prosthesis","Silicone breast form","Mastectomy bra","Post-mastectomy camisole","Nipple prosthesis","Adhesive breast prosthesis","American Breast Care","Trulife"],"tldr":"A breast form worn inside a bra after mastectomy instead of, or before, reconstruction. They come in silicone, foam and fibre, stick-on and pocket versions, and as stick-on nipples; American insurers cover replacements on a set schedule.","summary":"The FDA classes external breast prostheses as class I devices under 21 CFR 878.3800, product codes KCZ (used with adhesive) and NOJ (no adhesive). American billing codes describe the range: L8000 a mastectomy bra with pockets, L8001 and L8002 bras with an integrated form, L8015 a post-mastectomy camisole with a fibre-filled form, L8020 a mastectomy form, L8030 and L8031 silicone prostheses without and with integral adhesive, L8032 and L8033 reusable and custom nipple prostheses and L8035 a custom prosthesis moulded to the patient. A health plan policy that follows the Medicare coverage rules (OSU Health Plan) gives the expected useful life as two years for a silicone prosthesis, six months for fabric, foam or fibre forms and three months for a nipple prosthesis. The NHS Drug Tariff Part IX lists no breast prostheses. Firms registered with the FDA for these codes include American Breast Care and Anita Dr. Helbig (KCZ) and Trulife and Thuasne (NOJ).","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"FDA product code KCZ: external breast prosthesis used with adhesive","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=KCZ"},{"label":"FDA product code NOJ: external breast prosthesis, no adhesive","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NOJ"},{"label":"OSU Health Plan: external breast prostheses policy, HCPCS L8000 to L8039","url":"https://osuhealthplan.com/sites/default/files/2022-12/external_breast_prosthesis.pdf"},{"label":"openFDA registration and listing: firms listing product code NOJ","url":"https://api.fda.gov/device/registrationlisting.json?search=products.product_code:NOJ&limit=100"},{"label":"openFDA registration and listing: firms listing product code KCZ","url":"https://api.fda.gov/device/registrationlisting.json?search=products.product_code:KCZ&limit=100"}],"tags":["devices-gaps-2026-11"],"related":["knitted-knockers"],"cancers":["breast-cancer"],"sections":["supportive-care","devices"],"technologies":["breast-implants","rejuv-rehab-assistive-devices","nipple-areola-tattooing","pneumatic-compression-lymphoedema"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["mastectomy","breast-reconstruction"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, NHS Drug Tariff Part IX, FDA, maker and society pages)","editedOn":"2026-11-04"},"principle":"A weighted silicone gel or lightweight form shaped like a breast, held in a bra pocket or attached to the chest wall with adhesive, restores symmetry and balance after mastectomy.","strengths":["No surgery; can be worn soon after the wound heals","Weighted forms help posture and bra fit"],"limitations":["Heat, sweating and skin irritation with adhesive forms","Replacement depends on insurer or NHS service rules"]},"route":"/technologies/external-breast-prostheses/","neighbours":{"collection":[{"id":"knitted-knockers","kind":"collection","name":"Knitted Knockers","route":"/collections/knitted-knockers/"}],"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"technology":[{"id":"breast-implants","kind":"technology","name":"Breast implants for reconstruction (silicone gel, saline and shaped cohesive gel)","route":"/technologies/breast-implants/"},{"id":"nipple-areola-tattooing","kind":"technology","name":"Nipple and areola tattooing after breast surgery","route":"/technologies/nipple-areola-tattooing/"},{"id":"pneumatic-compression-lymphoedema","kind":"technology","name":"Pneumatic compression pumps for lymphoedema (Flexitouch, Lympha Press, Hydroven)","route":"/technologies/pneumatic-compression-lymphoedema/"},{"id":"rejuv-rehab-assistive-devices","kind":"technology","name":"The devices that do the restoring, and who pays for them","route":"/technologies/rejuv-rehab-assistive-devices/"}],"term":[{"id":"breast-reconstruction","kind":"term","name":"Breast reconstruction","route":"/terms/breast-reconstruction/"},{"id":"mastectomy","kind":"term","name":"Mastectomy","route":"/terms/mastectomy/"}]}}