GC Aesthetics 10-year Clinical Study

At Manchester Private Hospital, we look to push the envelope in medical research. Right now, we’re excited to be part of a cutting-edge clinical trial sponsored by GC Aesthetics®, a Dublin-based medical equipment manufacturer. This trial, for their latest PERLE™ silicone breast implants, aims to gather vital data on the safety and performance of these implants over the next decade.

Leading the charge is our very own Dr Nabilla Nasir, a top-notch consultant breast and oncoplastic surgeon dedicated to ensuring the safety and effectiveness of these implants for women across the UK. In this post, we delve into the importance of this study and what it means for the future of breast implant technology.

The Importance of Clinical Studies for Breast Implants

Clinical studies are the backbone of medical innovation. They make sure medical devices, like breast implants, are safe and effective. Long-term studies that follow strict guidelines are especially important for implants because they stay in the body for years. We need to know how they hold up over time and if there are any long-term risks.

This is especially important after the PIP scandal. PIP (Poly Implant Prothese) is a medical device manufacturing company founded in 1991. They started by making hydrogel and saline implants, but by 1997, they switched to silicone implants – a far more expensive material. To cut costs, they began using a cheaper, unapproved industrial-grade silicone. Things quickly went downhill.

By 2009, surgeons in France noticed these implants were failing at twice the industry average. When they ruptured, the silicone caused inflammation and scarring, raising fears of other harmful effects. By this time, PIP had sold over 2 million implants, and the problems kept coming in. It was so bad that by 2011, governments advised women to remove their PIP implants as a safety measure.

In 2012, the PIP founder was arrested, sent to prison, fined, and banned from working in medical services or running a company. This scandal caused a complete overhaul of medical device regulations in the UK and the rest of Europe. These new rules, i.e., the European Medical Devices Regulation (MDR), ensure high safety standards and restore trust. Post-marketing surveillance studies are crucial to making sure another scandal does not happen. It forces manufacturers to follow the strictest guidelines and be certain their devices, like implants, do not harm patients.

The PERLE Silicone Breast Implants

The PERLE™ silicone implant from GC Aesthetics® is an innovative choice for both aesthetic and reconstructive breast procedures. They are available in a wide range of profiles and sizes to meet the many needs and aesthetic goals of every woman.

Here’s what makes PERLE™ implants stand out:

BioQ™ Surface Technology: This tech makes the surface considerably smooth with a roughness of just five μm and is nearly free of cavities. This unique design means:

• Lower friction, making it easier to place
• Less tissue damage during surgery, leading to less inflammation
• Less fluid collection and bacterial adhesion, lowering the risk of capsular contracture

GCA® Ultra-link™ Shell Layer: This layer enhances the implant’s integrity so it can withstand high compressive forces while remaining soft and resistant to fractures.

GCA® 360 Barrier Layer: This layer is a new addition. It minimises silicone gel diffusion, further reducing the potential for capsular contracture.

Emunomic™ Breast Tissue Dynamic Gel: This proprietary gel mimics natural breast tissue. It offers better projection, fullness, and firmness that look just like natural contours in both standing and lying-down positions. Also, the implant is 100% gel-filled to minimise wrinkling.

All in all, the advanced features of PERLE™ implants ensure not only aesthetic satisfaction but also long-term reliability. By incorporating cutting-edge technologies and materials, GC Aesthetics is setting a new standard in breast implant quality and performance.

The GC Astehtics 10-Year Study

This 10-year study, sponsored by GC Aesthetics®, is prospective, multi-centre, observational, and non-comparative. This means it looks forward, involves multiple locations, and observes outcomes without comparing to other treatments.

During the study, investigators will monitor the performance of these implants over a decade to understand their safety, effectiveness, and duration. Along with this main goal, this study is also going to assess the likelihood of common breast implant complications, such as:

• Accidental rupture of implants in surgical pockets
• Delayed healing
• Granuloma, hematoma, early onset seroma
• Asymmetry, displacement of implant, ptosis
• Infection, pain, vein inflammation
• Scar tissue around the implant (capsular contracture), causing
• firmness and discomfort
• Calcium deposits
• Rupture of gel implants
• Wrinkling and folds
• Sensation changes
• Breast implant illness (BII)
• Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

Clinical Study at Manchester Private Hospital

Manchester Private Hospital is proud to participate in this important study. Leading the trial at our hospital is Dr. Nabilla Nasir, a consultant breast and oncoplastic surgeon with impressive credentials:

• Qualifications: MBBS, BSc, FRCS
• Professional Memberships: British Medical Association, Fellow of the Royal College of Surgeons of England (FRCS), Full Member of the General Medical Council (GMC), Medical Protection Society
• Expertise: Oncoplastic breast-conserving surgery, breast reconstruction, breast augmentation, breast reduction/uplift (mastopexy), correction of asymmetry, and revision procedures.

Dr Nasir has been a Consultant at Manchester Foundation Trust since 2011 and is driven to improve the quality of care for women with breast-related diseases. Her thorough approach ensures a low complication rate and patient-centred care.

Not only has Dr Nasir published extensively in peer-reviewed journals, but she also plays a vital role in medical education, serving as a faculty member for surgical courses. Experienced surgeons like Dr. Nasir are fundamental in the success of clinical studies. Their expertise and dedication ensure the study meets high standards of safety and best outcomes for patients.

Conclusion

Long-term clinical studies are central components of our medical system. They prevent us from repeating medical mistakes of our past and ensure innovations like the PERLE™ silicone breast implants are both safe for women across the UK and the world.

As we stand at the forefront of this vital research, Manchester Private Hospital is thrilled to participate in the GC Aesthetics® 10-year study. The PERLE implants, with their advanced technology and design, represent a significant step forward in breast implant safety and performance.

If you are interested in learning more about this study or participating, reach out to our dedicated team today.