FDA-Approved Since 1997: The 27-Year History of Gel Injections for Arthritis

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Introduction: This Treatment Has a Longer History Than Most Medications You Take

When patients hear about “gel shots” or viscosupplementation for knee arthritis, many assume it’s a newer, unproven treatment. Some worry they’re being offered something experimental.

The reality is quite different.

Hyaluronic acid injections received their first FDA approval in May 1997—the same year the first Harry Potter book was published and Tiger Woods won his first Masters. Nearly three decades later, these injections have one of the longest safety track records of any arthritis treatment still in use today.

This isn’t a treatment looking for evidence. It’s a treatment backed by 27 years of real-world use, 110+ clinical trials, and continuous FDA post-market surveillance.

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The First FDA Approvals (1997)

May 1997: Hyalgan Leads the Way

Hyalgan’s approval marked a turning point for arthritis treatment in America. The product had already been used successfully in Europe and other countries, and FDA approval opened the door for US patients to access this non-surgical option.

August 1997: Synvisc Follows

Within months of Hyalgan’s approval, Synvisc entered the market with a different approach—a cross-linked hyaluronic acid designed to provide longer-lasting joint lubrication.

These two 1997 approvals established viscosupplementation as a legitimate, FDA-regulated treatment category that would grow significantly over the following decades.

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The Evolution of Formulations

The Multi-Injection Era (1997-2009)

Early hyaluronic acid products required a series of injections—typically 3 to 5 weekly visits—to complete a treatment course. While effective, this created challenges for patients with transportation difficulties, busy schedules, or limited access to healthcare facilities.

The Single-Dose Revolution (2009-Present)

In 2009, Synvisc-One changed the treatment landscape by delivering the full therapeutic dose in a single injection. This innovation dramatically improved convenience for patients and opened viscosupplementation to those who couldn’t commit to multiple weekly visits.

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Current FDA-Approved Products

A Comprehensive Landscape

Today, patients and physicians have access to 15+ FDA-approved hyaluronic acid injection brands, offering a range of formulations, molecular weights, and treatment schedules.

Why So Many Options?

The variety of FDA-approved products reflects different approaches to the same goal: restoring joint lubrication. Products vary by:

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Manufacturing: Rooster Comb vs. Bacterial Fermentation

Two Approaches, Same Goal

HA injections are manufactured using one of two methods, each with distinct characteristics:

Which Is Better?

Clinical studies show no significant difference in effectiveness between avian-derived and fermented products. The choice primarily matters for patients with specific allergies. Both manufacturing methods produce pharmaceutical-grade hyaluronic acid that meets FDA standards.

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The 27-Year Safety Record

What Continuous FDA Oversight Means

By the Numbers

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What This Means for You

Reassurance for the Skeptical Patient

If you’ve been hesitant about gel injections because they seem “new” or “experimental,” the evidence tells a different story:

Questions to Ask Your Doctor

If you’re considering gel injections, the history of FDA approval shouldn’t be a concern. Better questions to discuss with your provider include:

1. Which specific product do you recommend for my situation?
2. Is a single-injection or series right for me?
3. Do you use imaging guidance (fluoroscopy or ultrasound) for injection accuracy?
4. What results have your patients typically experienced?
5. How does my insurance cover this treatment?

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Frequently Asked Questions

Are gel injections FDA-approved?

Yes. Hyaluronic acid injections have been FDA-approved since May 1997, when Hyalgan received the first approval. Today, 15+ brands are FDA-approved for knee osteoarthritis.

How long have gel injections been available?

Hyaluronic acid injections have been available in the United States for 27 years, since their first FDA approval in 1997. They were used in Europe even earlier.

Are these injections considered experimental?

No. With 27 years of FDA approval, 110+ clinical trials, and over 50 million doses of Hyalgan alone administered worldwide, viscosupplementation is a well-established treatment with extensive real-world evidence.

Why are there so many different brands?

Multiple manufacturers have developed different formulations to address various patient needs—single-dose convenience, different molecular weights, and options for patients with bird allergies (fermented products). All FDA-approved brands meet rigorous safety and efficacy standards.

Does Medicare cover gel injections?

Yes. Medicare Part B has covered hyaluronic acid injections for knee osteoarthritis continuously since 1997 when medically necessary. Coverage requires a diagnosis of knee OA and typically documentation of failed conservative treatment.

Which came first—Synvisc or Hyalgan?

Hyalgan was FDA-approved first (May 1997), followed by Synvisc (August 1997). Both have been available for over 27 years.

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References

1. FDA Premarket Approval Database. Device Approvals for Viscosupplementation Products. FDA

2. Fidia Pharma USA. Hyalgan Prescribing Information and Clinical Data.

3. Sanofi. Synvisc and Synvisc-One Product History and Prescribing Information.

4. FDA MAUDE Database. Post-Market Surveillance for Viscosupplementation Devices. FDA MAUDE

5. Centers for Medicare & Medicaid Services. National Coverage Determination for Viscosupplementation.

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Related Resources

Treatment Overview

• The FDA-Approved Treatment 80% of Patients Have Never Heard Of
• The Clinical Evidence: What 6,000+ Patients Show
• What Is Viscosupplementation?

Insurance and Coverage

• Does Medicare Cover Gel Injections? 2026 Guide
• Why 30% of Insurance Plans Don’t Cover Gel Injections
• Prior Authorization for Gel Injections: What You Need to Know

Brand Information

• Synvisc: Brand Overview
• Euflexxa: Brand Overview
• Hyaluronic Acid Injections: Treatment Guide