Breast implants are Class III medical devices — the FDA's highest-risk category, requiring premarket approval (PMA) backed by clinical data before any implant can be sold in the United States. That classification is the reason breast implants have generated one of the densest regulatory paper trails of any aesthetic device: original PMA applications for each new product, followed by years of supplements for manufacturing changes, design revisions, new labeling, and mandatory post-approval studies.
An analysis of 400 PMA records under FDA product codes FTR ("Prosthesis, Breast, Silicone Gel-Filled") and FWM ("Prosthesis, Breast, Saline-Filled") — spanning nine original PMA applications from 2000 through May 2026 — shows how the market consolidated around two manufacturers, how a 2019 recall reshaped the textured-implant landscape, and why a single 2024 approval was the most significant regulatory event in the category in more than a decade.
How breast implants are regulated
Unlike aesthetic energy devices, which usually reach the US through the 510(k) "substantial equivalence" pathway, every breast implant requires a PMA with clinical trial data demonstrating safety and effectiveness. Each new implant family needs its own original PMA. Once that original approval is granted, the manufacturer files supplements — for manufacturing-site or process changes, design or material modifications, labeling updates, and the post-approval studies the FDA mandates as a condition of approval.
Product code FTR covers silicone gel-filled implants; FWM covers saline-filled implants. The analysis here combines both.
The nine original PMA approvals
Across both codes, the FDA has granted nine original PMA applications for breast implant families. They map the entire modern history of the US implant market.
| PMA # | Product | Applicant | First approval | Status note |
|---|---|---|---|---|
| P990074 | Allergan saline | Allergan (AbbVie) | 2000 | Smooth saline line |
| P990075 | Mentor saline | Mentor (J&J) | 2000 | Smooth saline line |
| P020056 | Natrelle silicone | Allergan (AbbVie) | 2006 | Smooth and textured; BIOCELL textured recalled 2019 |
| P030053 | MemoryGel silicone | Mentor (J&J) | 2006 | Largest record count (78) |
| P040046 | Natrelle 410 (anatomical, highly cohesive) | Allergan (AbbVie) | 2013 | Textured; withdrawn after 2019 recall |
| P060028 | MemoryShape (anatomical) | Mentor (J&J) | 2013 | Textured; still marketed |
| P070004 | Sientra silicone | Tiger Aesthetics | 2012 | Sientra voluntarily withdrew textured line in 2019 |
| P120011 | Ideal Implant (structured saline) | Bimini Health Tech | 2014 | Baffle-layer structured saline; company restructured 2023 |
| P230005 | Motiva SmoothSilk | Establishment Labs | 2024 | First new PMA since 2013 |
The most consequential line in that table is the last one. After an eleven-year gap with no new original breast-implant PMA, the FDA approved Motiva SmoothSilk Round and Ergonomix on September 27, 2024 — the first new implant family cleared for the US market since 2013, and the first implant from a new manufacturer to enter in a generation.
Who owns the PMA landscape
By total PMA records — original approvals plus every supplement — the market is a two-company duopoly, with a long tail behind it:
| Applicant (current owner) | Total PMA records | Key brands |
|---|---|---|
| Mentor (Johnson & Johnson) | 188 | MemoryGel, MemoryShape, Mentor Saline |
| Allergan (AbbVie) | 139 | Natrelle, Natrelle 410, Allergan Saline |
| Tiger Aesthetics | 43 | Sientra |
| Bimini Health Tech | 27 | Ideal Implant |
| Establishment Labs | 3 | Motiva |
Mentor and Allergan together account for 327 of 400 records (82%). Mentor's lead reflects both its dual silicone-and-saline portfolio and the volume of post-approval activity the FDA has required of the MemoryGel and MemoryShape families. Allergan's count is lower in part because the 2019 recall removed its highest-record textured line (Natrelle 410, P040046) from active supplement filing — its last 410 record is dated 2021.
The tail tells a cautionary story. Sientra (now Tiger Aesthetics) and Ideal Implant (Bimini Health Tech) each entered as challengers and each ran into trouble: Sientra voluntarily withdrew its textured implants in 2019 alongside the broader textured-implant reckoning, and Ideal Implant's parent company underwent a financial restructuring in 2023. The Ideal Implant structured-saline device remains FDA-approved, but its trajectory is a reminder that a PMA is a license to market, not a guarantee of commercial survival.
What the 2024 Motiva approval changed
Motiva's PMA (P230005) is small in record count — three records through May 2026 — but large in significance. The implants feature a SmoothSilk surface designed for low inflammation, and the Ergonomix model uses an adaptive gel that changes shape with body position. In its US pivotal trial, Motiva reported a capsular contracture rate of roughly 0.5% at three years and a rupture rate around 0.6%, with zero reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) worldwide. More than 60,000 Motiva implants have been sold in the US since approval.
Two caveats matter. First, that safety data is early — three-year follow-up cannot match the decade-plus registries behind Mentor and Allergan smooth implants. Second, the current approval is for primary and revision augmentation in women 22 and older; Motiva is not yet FDA-approved for breast reconstruction, though Establishment Labs submitted a reconstruction PMA to the FDA in December 2025.
The 2019 recall and the textured-implant reckoning
The single most important event in the recent PMA record is the July 24, 2019 worldwide recall of Allergan's BIOCELL textured breast implants and tissue expanders. The FDA requested the recall because of an association with BIA-ALCL, a rare T-cell lymphoma of the immune system that develops in the scar capsule around implants. At the time of the recall, the FDA had identified 573 unique BIA-ALCL cases worldwide; roughly 84% were linked to Allergan's BIOCELL surface, and the agency estimated BIA-ALCL was about six times more likely with BIOCELL implants than with other textured implants. Smooth implants were not part of the recall, and no BIA-ALCL cases have been definitively linked to smooth-only implants.
The recall is visible in the PMA data: Allergan's Natrelle 410 (P040046) shows no supplement activity after 2021, and the textured-implant market contracted sharply. Today, the FDA's list of approved silicone implants is dominated by smooth-shell devices — Allergan Natrelle Inspira, Mentor MemoryGel, Sientra, and Motiva — with Mentor's MemoryShape (P060028) the principal remaining textured option still marketed in the US.
What supplements reveal
Of the 400 PMA records, the largest single category is manufacturing process changes — roughly 243 records reflecting transfers between facilities, sterilization updates, and packaging revisions. About 41 record design or component changes, and roughly 36 are labeling changes that update indications or patient instructions.
The heaviest years for PMA activity were 2015–2017 (when post-approval study requirements after the 2013 silicone re-approvals generated a flood of supplements) and a renewed surge in 2024–2025 as manufacturers updated labeling around the FDA's 2021 boxed-warning and patient-decision-checklist requirements and filed new supplement activity around Motiva's launch. The decision by the FDA in 2021 to require a boxed warning, a patient device card, and a patient decision checklist on all breast implants did not itself add PMAs — but it drove a wave of labeling supplements visible in the data.
What this means for patients
"FDA approved" means a PMA with clinical data. Every breast implant sold in the US has cleared the agency's most demanding device-review pathway, with required post-approval studies that continue to generate data long after launch. That is a higher bar than the 510(k) clearance most aesthetic devices meet.
New is not automatically safer. Motiva's early capsular contracture and rupture numbers are favorable, but they are three-year data from a single manufacturer's trial. The longest-running safety data still belongs to the established smooth silicone lines from Mentor and Allergan. A surgeon's experience with a specific implant family, and the length of its real-world track record, often matter more than its approval date.
The textured-implant landscape changed permanently. The 2019 recall was specific to Allergan's BIOCELL surface. Patients with smooth implants were not affected, and the FDA does not recommend removing BIOCELL implants in people without symptoms. But anyone considering a textured implant today is choosing from a much smaller menu than existed before 2019, and BIA-ALCL symptom awareness (persistent swelling or pain) remains part of informed consent regardless of surface type.
The duopoly is loosening — slowly. A Mentor-and-Allergan market that looked permanent now has a credible third silicone entrant in Motiva, and the reconstruction indication under FDA review. More competition may eventually affect pricing and access, but the long regulatory cycles mean market impact takes years.
What to ask your surgeon
- Which specific implant family and PMA number will be used, and is it smooth or textured?
- How long has that implant family been on the US market, and what does the post-approval study data show for capsular contracture, rupture, and BIA-ALCL?
- If a newer implant (such as Motiva) is recommended, how does the surgeon weigh its early favorable data against the longer track record of established lines?
- What are the signs of BIA-ALCL (persistent breast swelling or pain) to watch for, and what is the follow-up plan?
The FDA maintains a searchable PMA database and a public list of approved breast implants with patient and physician labeling at accessdata.fda.gov, where any patient can look up the full approval history for a specific implant by PMA number or product name.
Sources
- FDA PMA Database — breast implant product codes FTR and FWM: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
- FDA Labeling for Approved Breast Implants (current approved list, by PMA): https://www.fda.gov/medical-devices/breast-implants/labeling-approved-breast-implants
- FDA Breast Implant Postmarket Safety Information (ongoing post-approval studies): https://www.fda.gov/medical-devices/breast-implants/breast-implant-postmarket-safety-information
- FDA press release: FDA requests Allergan voluntarily recall BIOCELL textured breast implants (July 2019): https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
- Allergan voluntary recall of BIOCELL textured breast implants and tissue expanders: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-voluntarily-recalls-biocellr-textured-breast-implants-and-tissue-expanders
- Establishment Labs press release: US FDA approval of Motiva SmoothSilk implants (September 27, 2024): https://investors.establishmentlabs.com/press-releases/press-releases-details/2024/Establishment-Labs-Receives-U.S.-FDA-Approval-for-Motiva-Implants/default.aspx
- Motiva SmoothSilk Summary of Safety and Effectiveness Data (SSED), P230005: https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230005B.pdf
- ASPS patient safety: Allergan Biocell device withdrawal: https://www.plasticsurgery.org/patient-safety/breast-implant-safety/allergan-biocell-device-withdrawal
Analysis sample: FDA PMA database extract dated 2026-06-10, 400 PMA records under product codes FTR (Prosthesis, Breast, Silicone Gel-Filled) and FWM (Prosthesis, Breast, Saline-Filled), spanning nine original PMA applications (P990074, P990075, P020056, P030053, P040046, P060028, P070004, P120011, P230005) and their supplements through May 2026. Analysis by AestheticMedGuide.
