The Regulatory History of Breast Implants in the U.S. and Why They Are Safer Today

Name: Brian Bassiri-Tehrani MD PLLC
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Regulatory History of Breast Implants in the U.S.

April 26, 2026

Why Breast Implants Are Among the Most Studied Medical Devices

Breast implants are among the most studied medical devices in the United States, with decades of ongoing clinical research, post-approval surveillance, and FDA oversight aimed at understanding long-term safety and outcomes¹.

The Early Years: Breast Implants Before FDA Oversight

The story of breast implant regulation in the U.S. reflects the evolution of modern medical device oversight itself. Silicone gel breast implants were first introduced in the early 1960s, long before the FDA had formal authority to regulate medical devices². At that time, implants entered the market without the kind of clinical trials or safety data that would be required today, a reality that would later shape decades of regulatory scrutiny.

1976: The Birth of Modern Medical Device Regulation

Everything changed in 1976, when Congress passed the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. This legislation created the modern framework for device regulation and initially placed breast implants into Class II, allowing them to remain on the market under a “grandfathered” status².

Rising Safety Concerns and FDA Reclassification in the 1980’s

However, as concerns about implant safety began to emerge in the 1980s, the FDA reclassified breast implants as Class III devices in 1988, requiring premarket approval (PMA), which is the most rigorous level of review for medical devices².

1992 FDA Moratorium on Silicone Breast Implants

By 1991, the FDA convened advisory panels to evaluate silicone gel implants, concluding that manufacturers had not provided sufficient safety data². This culminated in a pivotal moment in 1992, when the FDA effectively placed a moratorium on silicone implants for cosmetic use. Their conclusion was clear: there was not enough evidence to support unrestricted use². Silicone implants remained available only under controlled clinical studies or for specific indications such as breast reconstruction, marking one of the most restrictive periods in implant history.

The Era of Clinical Trials and Evidence-Based Approval

Over the next decade, the FDA required extensive clinical trials and long-term data collection. This period fundamentally reshaped how implants were studied, shifting toward evidence-based approval and ongoing surveillance. In 2000, saline implants became the first to receive formal FDA approval after clinical trials demonstrated acceptable safety profiles.

2006: Reintroduction of Silicone Implants with Strict Oversight

A major turning point came in 2006, when the FDA approved silicone gel implants from Allergan and Mentor for the first time since the moratorium. Importantly, this approval came with strict conditions: manufacturers were required to conduct large, long-term post-approval studies to better understand complications and durability over time². This marked the beginning of a new era of continuous monitoring rather than one-time approval.

Ongoing FDA Monitoring and Long-Term Safety Data

In the years that followed, the FDA continued to refine its oversight as new data emerged. Advisory panel meetings, updated safety communications, and ongoing post-market studies became standard³. By 2011, the FDA was reviewing long-term outcomes and reinforcing the importance of continued data collection, acknowledging that understanding implants is an evolving process².

2019–2021: Increased Transparency, Recalls, and Patient Protections

More recently, regulatory actions have focused on transparency and patient education. In 2019, the FDA requested a recall of certain textured implants (Biocell) due to their association with a rare lymphoma (BIA-ALCL)⁴. In 2021, the FDA strengthened safety requirements further by mandating boxed warnings and patient decision checklists for each breast implant manufacturer to ensure fully informed consent⁵.

Breast Implants Today: Continuous Monitoring and Evolving Safety

Today, breast implants remain one of the most closely monitored devices in medicine. The FDA continues to collect real-world data, track complications, and require ongoing studies even after approval. This continuous cycle of evaluation reflects an important reality: the regulatory history of breast implants is not static. Rather, it is a living process, shaped by science, patient outcomes, and a commitment to improving safety over time. Because of the long regulatory history of breast implants in the U.S., today’s newest generation implants are among the safest ever with the lowest risks to date.