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FDA product code FWM · class 3 · General, Plastic Surgery
Prosthesis, breast, inflatable, internal, saline: medical device reports filed with FDA
118,312 reports carry this product code, 1992–2026; 30 brands with a page.
- 118,312
- reports with this product code
- 0.5% of all MAUDE reports
- 9,047
- reports, 12 months to August 2026
- 8,991 in the 12 months before
- 2.3%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code FWM is FDA's classification for "Prosthesis, breast, inflatable, internal, saline" (general, Plastic Surgery panel), a class 3 device. 118,312 medical device reports carry this product code, 0.5% of the MAUDE database, from March 1992 to August 2026.
9,047 reports arrived in the 12 months to August 2026, close to the 8,991 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (95.1%), malfunction (2.3%) and other (2.2%). 30 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Brands with this product code
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Allergan Costa Rica | 60,382 | 51% |
| Mentor Texas | 40,213 | 34% |
| Mentor | 2,324 | 2% |
| Biosil | 1,588 | 1.3% |
| Ideal Implant | 1,521 | 1.3% |
| Pip | 1,310 | 1.1% |
| Mcghan Medical | 850 | 0.7% |
| Allergan | 767 | 0.6% |
| Mentor Worldwide | 521 | 0.4% |
| American Heyer-Schulte | 406 | 0.3% |
| Dow Corning | 97 | 0.1% |
| Medical Engineering | 15 | 0% |
| Sientra | 2 | 0% |
| Allergan Pringy | 1 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Fluid/blood leak | 43,483 | 36.8% |
| Material rupture | 37,015 | 31.3% |
| Device appears to trigger rejection | 7,557 | 6.4% |
| Explanted | 6,758 | 5.7% |
| Deflation, cause unknown | 4,707 | 4% |
| Patient-device incompatibilitythe device did not suit the patient | 4,612 | 3.9% |
| Replace | 2,886 | 2.4% |
| Deflation problem | 1,547 | 1.3% |
| Migrationthe device moved from where it was placed | 1,190 | 1% |
| Rupture, cause unknown | 909 | 0.8% |
| Implant, removal of | 786 | 0.7% |
| Insufficient device problem information | 593 | 0.5% |
| Leak/splashthe device leaked | 479 | 0.4% |
| Malposition of device | 338 | 0.3% |
| Device issuea problem with the device | 260 | 0.2% |
| Unintended deflation | 224 | 0.2% |
| Migration or expulsion of device | 208 | 0.2% |
| Device remains implanted | 181 | 0.2% |
| Peeled/delaminated | 175 | 0.1% |
| Other (for use when an appropriate device code cannot be identified) | 173 | 0.1% |
Questions about prosthesis, breast, inflatable, internal, saline reports
What is product code FWM?
FDA's classification code for "Prosthesis, breast, inflatable, internal, saline", class 3, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.
How many reports carry this code?
118,312 reports through August 2026, 9,047 of them in the latest 12 months.
Which brands appear most often?
Style 68 Saline Filled Breast Implant (36,335), MENTOR Smooth Round Moderate Profile (16,249), UNK Mammary Implant (14,360), MENTOR Smooth Round Moderate Plus Profile (6,558) and UNK Saline Implant (6,334). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.