RecruitingOBSERVATIONAL

Post-market Prospective Clinical Study of Nagor Perle Mammary Implants

This study is investigating a new range of smooth silicone breast implants, known as Nagor Perle implants. Many people have breast implant surgery for cosmetic reasons or after breast cancer removal. It's very important to track how safe and effective these medical devices are over a long period. This research aims to gather information over 10 years about how these implants perform. They will specifically look for common problems that can develop, such as the tissue around the implant hardening (called capsular contracture) or the implant rupturing. The study will also keep an eye on any other issues that might come up. This long-term follow-up helps ensure that patients and doctors have clear information about the safety and lasting quality of these implants.

At a glance

Status

Recruiting

Sponsor

GCA (Eurosilicone)

Enrolment target

Start

01 Jun 2024

Estimated completion

01 Sep 2038

Breast Reconstruction Breast Reconstruction Following Mastectomy Breast Revision Breast Augmentation Breast Reconstruction With Silicone Implants Breast Reconstruction After Mastectomy Breast Reconstruction Surgery Breast Implants

What is this study about?

This study is all about a new type of breast implant called Nagor Perle. These are smooth, gel-filled implants. People choose to have breast implants for different reasons, like to change the size or shape of their breasts (cosmetic surgery) or to rebuild a breast after an operation to remove it, often due to cancer (reconstructive surgery). It's really important to know that medical devices like breast implants are safe and work well over time.

The main goal of this study is to see how these new Nagor Perle implants perform over a long time, specifically 10 years. Doctors want to understand any potential problems that might happen, such as the tissue around the implant becoming hard (that's called capsular contracture) or the implant itself breaking. These kinds of problems can sometimes take years to show up, which is why a long study like this is so important. They will also be looking out for any other issues that might arise.

By following patients for a whole decade, researchers can build a complete picture of the implants' safety and effectiveness. This information is key for making sure that patients choosing breast implants can feel confident about their decision, and that doctors have the clearest possible understanding of the long-term results.

Key takeaways

Studies a new type of Nagor Perle silicone breast implant.
Aims to check safety and performance over 10 years.
Focuses on common implant issues like hardening or rupture.
Participants must be women aged 18-65 having Nagor Perle implants.
Requires follow-up appointments for 10 years after surgery.

Who may be eligible?

This study is looking for women aged between 18 and 65 years old. You might be considered if you are having breast implant surgery with the Nagor Perle implant for specific reasons. This includes women having breast reconstruction after a mastectomy (even if you've had radiotherapy) or cosmetic breast enlargement. It also includes women having revision surgery, which means replacing or adjusting existing implants. You must be able to attend all the follow-up appointments required by the study.

There are also some reasons why you might not be able to join. For example, if your Body Mass Index (BMI) is above a certain level (BMI over 30 for cosmetic surgery or over 32 for reconstruction). If you have certain health conditions like an autoimmune disease, problems with wound healing, a weakened immune system, or if your breast tissue doesn't have good blood flow, you won't be able to take part. Also, if you've recently been in another medical study involving drugs or chemicals, have a known allergy to silicone, or if your doctor thinks you have active cancer in the breast that won't be completely removed during surgery, you wouldn't be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged between 18 and 65?
Are you having a Nagor Perle breast implant for cosmetic reasons, reconstruction after mastectomy, or revision surgery?
Are you able to attend follow-up appointments for 10 years after your surgery?
Do you have a healthy immune system and no severe long-term health conditions that affect healing?
Is your Body Mass Index (BMI) within the study's limits (e.g., not over 30 for cosmetic surgery)?
Have you not participated in a non-cancer-related drug study in the last 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have your breast implant surgery with the Nagor Perle implant. Before your operation, you'll have an initial check-up. After your surgery, you will need to attend follow-up appointments. These appointments are scheduled at 12 months after your surgery, and then again after 3, 5, 8, and 10 years. During these visits, doctors will check how you are doing, how the implants are performing, and look for any issues or complications. There isn't any extra medication involved with this study; it's focused on observing the long-term effects of the implants themselves. The total duration of your involvement in the study will be 10 years.

Potential risks and benefits

Taking part in this study helps doctors understand more about the long-term safety and performance of these new breast implants, which can benefit future patients. However, as with any surgery, there are potential risks, and breast implants specifically can lead to complications such as the tissue around them hardening or the implant rupturing. The study's purpose is to monitor these and other potential issues over time. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NHS Manchester
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is 'capsular contracture'?

Capsular contracture is when the scar tissue that naturally forms around a breast implant becomes hard and tight. This can sometimes cause pain or change the shape of the breast.

Why does the study last 10 years?

Some problems with breast implants, like hardening or breaking, can take many years to appear. The 10-year follow-up helps doctors understand these long-term effects completely.

Will I have extra doctor visits if I join?

Yes, you'll have specific follow-up appointments beyond your usual care, at 12 months, and then at 3, 5, 8, and 10 years after your surgery.

Can I still join if I've had radiotherapy for breast cancer?

Yes, for breast reconstruction after a mastectomy, you can still be considered even if you've had radiotherapy.

What if I decide I don't want to be in the study anymore?

You can choose to leave the study at any time. This won't affect the medical care you receive.

How to find out more

Clinical Affairs Manager

perle10pmcf@gcaesthetics.com +44 (0)1236 780780 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.