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.

The Private Clinic does not currently use any brand of textured implants. 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.

Capsular Contracture

What is 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.

Is Capsular Contracture Treatable?

Yes, it is treatable, although it may require additional surgery. Your surgeon can discuss this with you in more detail.

What else should I know about Capsular Contracture?

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

What is an 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.

What are the symptoms of Breast Implant Rupture?

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.

Is an Implant Rupture Treatable?

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. This cover period can be extended with our unique Extended Aftercare Scheme for additional peace of mind, ask your co-ordinator for details.

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.

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

What is 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.

Is BIA-ALCL Common?

BIA-ALCL is rare and the true incidence is hard to estimate. To date, the estimated incidence rates in scientific literature range from 0.03% to 0.003%, or 1 in 3,817 to 1 in 30,000. Current MHRA (The UK Regulator for Medical Devices) estimates that the rate is 1 in 24,000.

What types of implants are associated with BIA-ALCL?

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.

What causes BIA–ALCL?

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.

How is BIA–ALCL treated?

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.

What are the symptoms that I should look out for?

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.

What types of implants are associated with BIA-ALCL?

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 French Government has decided to ban certain textured implants how does this affect me?

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.

Where can I find further information about BIA-ALCL?

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

INFORMATION REFERENCES

  • Campanale A, Boldrini R, Marletta M. 22 Cases of Breast Implant- Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health. Plast Reconstr Surg. 2018;141(1):11e-9e.
  • Loch-Wilkinson A, Beath KJ, Knight RJW, Wessels WLF, Magnusson M, Papadopoulos T, et al. Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk. Plast Reconstr Surg. 2017;140(4):645-54.
  • Doren EL, Miranda RN, Selber JC, Garvey PB, Liu J, Medeiros LJ, et al. U.S. Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Plast Reconstr Surg. 2017;139(5):1042-50
  • MHRA Guidance Breast implants and Anaplastic Large Cell Lymphoma (ALCL) Published 26 July 2017. Last updated 26 November 2018

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