Breast Implant Safety
Information for Patients Considering Breast Implants
As a potential breast enlargement patient you need to consider the potential risks and consequences that sometimes can occur with the surgery you are seeking. Breast Augmentation surgery carries risk just like any surgical procedure would do. The common risks are infection, seromas, excessive bleeding or reaction to the anaesthetic.
Our experienced surgeons will discuss the risks of breast implant surgery with all patients in detail at their initial consultation.
All of our breast implant patients are registered with the Breast and Cosmetic Implant Registry (BCIR) which allows them to be contacted should any complications involving their implants occur. We are dedicated to providing all of our patients with up-to-date information regarding breast implants including any notices from The British Association of Aesthetic Plastic Surgeons (BAAPS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS).
The main risks to consider related to Breast Implants are detailed below;
Breast Implant Illness
Some patients report symptoms such as fatigue, cognitive dysfunction (brain fog, memory loss), muscle aches, joint pain following the insertion of breast implants. This is being referred to as Breast implant Illness (BII). BII is characterized by chronic negative health effects. Symptoms are widespread and can be related to the chronic foreign body response and inflammation.
Capsular Contracture
Capsular Contraction is the body’s natural reaction to foreign objects and only turns into a complication if you feel like your implants are being squeezed and you start experiencing some discomfort.
After surgery, your body begins to naturally surround the implant with a layer of scar tissue. This tissue is called a “capsule” because it encapsulates (or surrounds) the implant. Sometimes, for a number of reasons, the capsule can tighten and squeeze the implant—this is called capsular contracture. It can cause the breast to feel hard, look misshaped, and can sometimes be painful.
Yes, it is treatable, although it may require additional surgery. Your surgeon can discuss this with you in more detail.
It is one of the most common reasons for reoperation, and is also a risk factor for implant rupture. As part of your initial clinical assessment your surgeon will take steps to reduce your chance of developing capsular contracture. The severity of capsular contracture is graded using the four-grade Baker scale; Grade I capsular contracture is the least severe and Grade IV is the most severe.
Breast Implant Rupture
An implant rupture is a tear or hole in the breast implant shell. When this occurs in a silicone gel-filled implant, the gel may remain in the shell, leak into the tissue (or capsule) that forms around the implant or spread beyond the capsule. Breast implant ruptures can be caused by a variety of causes such as; excessive trauma to the chest, extreme capsular contracture, or damage by surgical instruments.
The symptoms of implant rupture that a woman may notice include: decreased breast size, changes in breast shape, pain or tenderness and swelling. In some cases, a “silent rupture” may occur and the woman will experience no changes to the way the implant looks or feels. This type of rupture is diagnosed by magnetic resonance imaging (MRI), and this may be recommended as part of your post-surgery medical examinations.
Yes, it is. The removal of silicone gel-filled breast implants is recommended. Your surgeon will diagnose if your implant has ruptured and determine if you should have it replaced or removed. At The Private Clinic you are initially provided with 3 years cover for higher grades of capsular contracture and breast implant rupture that may require further treatments. For additional peace of mind, ask your co-ordinator for more details.
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
BIA-ALCL is Breast Implant-Associated Anaplastic Large Cell Lymphoma, a rare type of cancer that can arise around breast implants placed for either reconstructive or cosmetic indications. Currently, the cause of BIA-ALCL is not clearly understood.
BIA-ALCL is rare and the true incidence is hard to estimate.
MHRA (The UK Regulator for Medical Devices) has estimated incidence of BIA-ALCL, based on confirmed cases where surgery occurred in the UK, is 1 per 16,500 implants sold.
References: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) – GOV.UK (www.gov.uk)
BIAALCL has been associated with both saline and silicone implants, round and anatomical implants, all gel types, all types of implant texturing, and all projections and sizes, as well as breast implants that have been used for both reconstructive and cosmetic purposes.
Presently no specific risk factors have been identified by health bodies around the world that are studying this disease. However, factors such as breast implant texture, genetics, and bacteria have been implicated and are presently undergoing further study. Breast implants have different surface textures, including smooth or textured. For cases reported to date, BIAALCL has been seen most often in patients with textured implants. Your consultant can provide more information at your consultation and please do not hesitate to ask any question you may have.
When diagnosed early BIAALCL can be successfully treated, by removing the breast implant and surrounding scar capsule. However, additional treatment may be necessary depending on the individual and whether the disease has spread throughout the body. As with all cancers it is important to be diagnosed and treated as early as possible.
At The Private Clinic we advise it is good health practice to self-examine breasts regularly and we would recommend that all patients with breast implants to do this. Should anything such as a swelling of the breast—often caused by fluid building up around the implant, or other symptoms which includes pain, lumps, and unevenness between breasts be detected an appointment to see your surgeon or GP should be made as soon as possible.
BIA-ALCL has been associated with both saline and Silicone implants, round and anatomical implants, all gel types, all types of implants texturing and all projections and sizes, as well as breast implants that have been used for both reconstructive and cosmetic purposes.
Guidance for patients regarding textured implants:
The Private Clinic follows the latest UK regulatory advice from the Medicines and Healthcare Products Regulatory Authority (MHRA) and the British Association of Aesthetic Plastic Surgeons (BAAPS). Based on this advice and other relevant agencies, we regularly review the types of breast implants we offer to patients. The British Association of Aesthetic Plastic Surgeons advises that concerned patients need not take any action at this stage. They should continue their routine follow up with their healthcare professional and discuss any questions they have about their breast implants. There is no need to remove or exchange any current implants based on the most up-to-date scientific data available. Indeed, unnecessary surgery may cause additional harm in a small number of patients. We advise any patients with new symptoms such as swelling or pain to contact their implant surgeon for specific advice, otherwise, they should make a routine appointment with their GP when available to discuss their concerns. We would encourage women to continue to self-examine their breasts as a matter of good health. Should you notice any changes, feel any discomfort, or have any other concerns then please contact The Private Clinic and we will arrange for you to see your surgeon or consult your General Practitioner (GP).The majority of patients in the UK with breast implants will have textured surface implants in their breasts. According to all the latest scientific data these remain safe devices and there is no indication for any woman to consider removing or replacing their implants. Patients should continue with any planned follow-up they have arranged.
Additional information regarding breast implants and BIA-ALCL can be found on the following sites:
Medicines and Healthcare products Regulatory Agency
https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl
British Association of Aesthetic and Plastic Surgeons
https://baaps.org.uk/patients/safety_in_surgery/breast_implant_safety.aspx
Association of Breast Surgery
https://associationofbreastsurgery.org.uk/clinical/bi-alcl
Gov.uk
https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl
Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group Statement
Statement from PRASEAG on breast implants and guidance for patients
Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants
Date Issued: September 8, 2022
The U.S. Food and Drug Administration (FDA) are informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. Currently, the incidence rate and risk factors for squamous cell carcinoma and various lymphomas in the capsule around the breast implants are unknown.
The FDA believes that occurrences of SCC or various lymphomas in the capsule around the breast implant are rare but we believe that all patients considering breast implants should be aware of the reports.
If you have breast implants, you do not need to change your routine medical care or follow-up. We recommend that patients continue to monitor their breast implants and if there are any abnormal changes in their breasts or implants to promptly contact your surgeon or clinic.
If you do not have symptoms, the FDA does not recommend the removal of breast implants because of this safety communication.
For more information please see; https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda
Update Issued: 8th March 2023
The U.S. Food & Drug Administration (FDA) has provided an update on their previous reports of squamous cell carcinoma (SCC) in the scar tissue (capsule)
that can form around breast implants.
The FDA continues to believe that occurrences of SCC in the capsule around the breast implant are rare. The cause, incidence and risk factors remain unknown.
The advice still remains as above, patients with breast implants are to monitor their breast implants and contact their clinic or surgeon should they notice any changes. Patients considering breast implants will be provided with information regarding squamous cell carcinoma and various lymphomas in the capsule around breast implants during their consultation.
For more information please see: https://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication
Update Issued: 18th July 2023
A joint statement from the Association of Breast Surgery (ABS), the British Association of Aesthetic Plastic Surgeons (BAAPS), the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) has been released on the topic of Breast Implant Associated Squamous Cell Carcinoma and other Breast Implant Associated Lymphomas.
The statement provides information on what is known and recommended for practice in the United Kingdom following the USA Food and Drug Administration (FDA) safety alert previously released in September 2022.
The advice remains as above, patients with breast implants are to monitor their breast implants and contact their clinic or surgeon should they notice any changes. Patients considering breast implants will continue to be provided with information regarding squamous cell carcinoma and various lymphomas in the capsule around breast implants during their consultation.
See the report here: https://baaps.org.uk/media/press_releases/1878/joint_statement_on_breast_implant_associated_squamous_cell_carcinoma_and_other_breast_implant_associated_lymphomas
Update August 2023
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released a statement detailing cases where squamous cell carcinoma (SCC) and different types of lymphoma have been found in the fibrous capsule that forms around breast implants.
MHRA has not recommended any new guidance but has detailed that they will be closely monitoring for cases in the UK. They will also continue to work closely with other regulators across the world and seek advice from independent expert groups such as the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) where appropriate.
