FDA Issues Urgent Safety Warning on RF Microneedling: What Long Beach Patients Need to Know

Hello, My Dears –

If you’ve been following the world of medical aesthetics lately, you may have heard some concerning news. On October 15, 2025, the FDA issued an urgent safety communication about radiofrequency (RF) microneedling: a treatment that many of us have come to trust for skin rejuvenation, particularly for the neck and décolletage.

As the director and founder of Novel U Wellness in Long Beach, and as a board-certified internist, I believe it’s my responsibility to help you understand exactly what this warning means, how to stay safe, and why choosing the right provider has never been more important.

Understanding RF Microneedling for Neck and Décolletage Treatment

Before we dive into the FDA warning, let me explain what RF microneedling actually is, because it’s quite different from traditional microneedling that you might be familiar with.

RF microneedling, which we offer through our Agnes RF microneedling technology here at Novel U Wellness, combines the benefits of traditional microneedling with the power of radiofrequency energy. The treatment uses ultra-fine needles that penetrate the skin while simultaneously delivering controlled radiofrequency heat into the deeper dermal layers.

This dual-action approach is particularly effective for treating the delicate skin of the neck and décolletage, which are the areas that often show the first signs of aging with crepey texture, fine lines, and loss of firmness. The RF energy stimulates collagen production at a deeper level than traditional microneedling alone, resulting in significant skin tightening and rejuvenation.

At Novel U Wellness, we’ve seen remarkable results using Agnes RF for neck rejuvenation, décolletage smoothing, and overall skin texture improvement. The technology is sophisticated and, when used properly, highly effective.

The FDA’s Safety Communication: What You Need to Know

The FDA released a safety communication warning healthcare providers and patients about serious complications associated with RF microneedling devices. These aren’t minor side effects. The FDA has received reports of:

• Thermal burns ranging from superficial to deep dermal burns requiring surgical intervention
• Permanent scarring that can be devastating when the goal was to improve skin appearance
• Lipoatrophy (fat loss under the skin) creating hollowing or indentations, particularly noticeable in the neck and facial areas
• Disfigurement with lasting changes to appearance
• Nerve damage causing numbness, pain, or altered sensation

I want to be completely transparent with you: while not everyone who undergoes RF microneedling experiences these complications, the FDA felt compelled to issue this warning because they’re seeing enough reports to warrant serious attention.

Why These Complications Occur: The Critical Role of Expertise

Here’s what I find most important about this FDA warning: it emphasizes that RF microneedling is a medical procedure, not simply a cosmetic treatment. This distinction matters enormously. The complications reported to the FDA appear to be related to specific factors:

Device Settings and Parameters: RF microneedling devices have multiple adjustable settings, such as: needle depth, energy levels, pulse duration, and the number of treatment passes. For delicate areas like the neck and décolletage, where skin is thinner and more sensitive, these parameters must be precisely calibrated. Too aggressive settings can cause thermal injury to underlying tissues.

Operator Training and Experience: This is where my medical training becomes crucial. As a board-certified internist with extensive training in facial and neck anatomy, I understand not just how to operate the device, but also the intricate anatomy beneath the skin, where nerves run, where blood vessels are located, how different skin types respond to heat, and how skin thickness varies across different treatment areas.

The American Academy of Dermatology emphasized in their response to the FDA warning that board-certified physicians undergo rigorous training in facial and neck anatomy, including the precise location of nerves and muscles. This expertise is critical for minimizing risks, especially when treating areas like the neck and décolletage where the skin is more delicate.

Patient-Specific Factors: Your individual skin type, thickness, previous treatments, medications, and underlying health conditions all affect how your skin responds to RF energy. This is why we conduct thorough consultations before any RF microneedling treatment at Novel U Wellness.

How We Ensure Safety at Novel U Wellness

I want you to know exactly how we approach RF microneedling safety here in our Long Beach practice, particularly for neck and décolletage treatments where precision is paramount.

Comprehensive Consultation: Before any RF microneedling procedure, we conduct a detailed assessment of your skin type, medical history, current medications, and treatment goals. We discuss both the benefits and realistic risks specific to your situation.

Agnes RF Technology: We use the Agnes RF system, which utilizes insulated microneedles that deliver RF energy precisely where it’s needed while protecting surrounding tissue. This technology allows for accurate, controlled treatment—particularly important for delicate areas like the neck.

Customized Treatment Parameters: I personally adjust every treatment parameter based on your individual skin characteristics and the specific area being treated. The settings I use for décolletage treatment differ from those for facial areas, taking into consideration the patient’s skin thickness and sensitivity.

Medical Setting and Protocols: All our RF microneedling procedures are performed in our fully equipped medical spa with proper sterile techniques and established protocols for managing any complications should they arise.

Post-Treatment Monitoring: We provide detailed aftercare instructions and maintain close follow-up to ensure optimal healing and results.

What This Means for Your Neck and Décolletage Treatment

If you’ve been considering RF microneedling for your neck or décolletage, or if you’ve already had the treatment, here’s my guidance:

If You’re Considering Treatment: Don’t let this FDA warning scare you away from a potentially transformative procedure. Instead, use this information to make informed decisions. Ask potential providers:

• What specific device do they use?
• How many neck and décolletage RF microneedling procedures have they performed?
• What training and certification do they have?
• How do they customize treatment parameters for delicate areas?
• What is their complication rate and how do they handle adverse events?

If You’re Scheduled for Treatment: Have an open conversation with your provider about this FDA warning. A good provider (and I consider myself one) will welcome these questions and provide thorough, honest answers about how we prevent complications.

If You’ve Had Treatment and Have Concerns: If you’re experiencing unusual pain, signs of burns, increasing redness or swelling, numbness, or any changes that concern you, seek medical attention immediately. Don’t wait and hope it resolves. These complications can worsen without proper intervention.

The Bottom Line: Expertise Matters

RF microneedling, including treatments for the neck and décolletage, can be performed safely and effectively when done by experienced, properly trained healthcare providers in appropriate medical settings.

Experts who commented on the FDA warning noted that RF microneedling is “overwhelmingly safe and effective in skilled hands.”

This is not a procedure where you should shop based on price alone or choose convenience over expertise. This is a medical procedure that requires medical knowledge, anatomical understanding, and technical skill.

Your Safety Is My Priority

At Novel U Wellness, your safety is always our top priority. Yes, we want you to achieve beautiful results, such as smoother, firmer skin on your neck and décolletage, a more youthful appearance – but never at the expense of your wellbeing. This FDA warning serves as an important reminder that medical aesthetics, while incredibly rewarding, must always be approached with the respect and caution that any medical procedure deserves.

If you’re interested in RF microneedling for your neck, décolletage, or any other area, I invite you to schedule a consultation. We’ll take the time to thoroughly assess your skin, discuss your goals, review all available treatment options, and create a personalized plan that prioritizes both your results and your safety.

You can reach us at Novel U Wellness in Long Beach by visiting our website at NovelUWellness.com or calling 562-349-0239. Let’s work together to help you look and feel your absolute best! And remember: knowledge is power! Being informed allows you to make the best decisions for your aesthetic journey.

Wishing You Light and Love,

Dr. Shahnoos

Board-Certified Internal Medicine
Director, Novel U Wellness & Med Spa
Long Beach, California