Are silicone prostheses bad for your health?

Silicone breast prostheses have been a topic of extensive research and discussion within the medical community and among the public. The safety of silicone breast implants has been scrutinized since their introduction, leading to various studies and regulatory reviews. Here’s what current research and expert consensus indicate regarding the health implications of silicone prostheses:

FDA Approval and Monitoring

The U.S. Food and Drug Administration (FDA) has approved silicone breast implants for breast augmentation in women aged 22 and older and for breast reconstruction in women of any age. The approval followed rigorous reviews of the scientific evidence concerning the safety and effectiveness of these devices. The FDA continues to monitor the safety of silicone implants through post-approval studies and adverse event reports.

What are the risks of having a silicone prosthesis?

Silicone prostheses, commonly used for breast reconstruction or augmentation, are generally considered safe. However, like any medical device or surgical procedure, they come with potential risks and complications. It's essential to be well-informed about these risks when considering a silicone prosthesis. Here are some of the concerns and potential complications associated with silicone breast prostheses:

Capsular Contracture: One of the most common complications is capsular contracture, where the scar tissue or capsule that naturally forms around the implant tightens and squeezes the implant. This can cause the breast to feel hard and may cause discomfort or change the breast's appearance.

Implant Rupture or Leakage: Silicone implants can rupture or leak. While modern silicone gel is more cohesive and less likely to leak into the body than older types, a rupture can still occur, often without symptoms ("silent rupture"). An MRI is recommended periodically to check for ruptures in silicone implants.

Breast Pain and Changes in Sensation: Some individuals may experience breast pain or changes in nipple and breast sensation following surgery, which can be temporary or permanent.

Infection and Bleeding: As with any surgery, there is a risk of infection and bleeding. Proper surgical technique and post-operative care are crucial to minimize these risks.

Implant Displacement: The implant may move from its original position, which can affect the appearance of the breast and may require additional surgery to correct.

Anaplastic Large Cell Lymphoma (BIA-ALCL): A rare but serious risk associated with breast implants is Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma (cancer of the immune system). It is not breast cancer, but a cancer that develops in the fluid and scar tissue around the implant.

Autoimmune Symptoms: Some individuals report experiencing symptoms similar to autoimmune diseases, such as fatigue, joint pain, and muscle aches, after receiving silicone breast implants. Research is ongoing to better understand the relationship between breast implants and these symptoms, sometimes referred to as "breast implant illness," although a direct causal link has not been firmly established.

Necessity for Future Surgeries: Breast implants are not lifetime devices, and future surgeries may be required to replace or remove the implants, whether due to complications, changes in breast appearance over time, or personal preference.

Screening Mammography Challenges: Breast implants can make mammography more challenging, potentially obscuring breast tissue and making it harder to detect breast cancer. Inform your radiologist about your implants before the screening.

It's important for individuals considering silicone breast prostheses to discuss all potential risks and benefits with a qualified plastic surgeon. A thorough consultation can help ensure that you make an informed decision that aligns with your health and aesthetic goals.

What is silicone disease?

"Silicone disease" is a term sometimes used to describe a range of symptoms purportedly experienced by individuals with silicone breast implants. These symptoms are believed by some to be related to the body's reaction to silicone, a synthetic material used in various medical devices, including breast implants. However, it's important to note that "silicone disease" is not a medically recognized condition, and the existence of a syndrome directly caused by silicone implants remains controversial within the medical community.

Reported Symptoms

Individuals who report suffering from "silicone disease" describe a variety of symptoms that mimic autoimmune or connective tissue disorders, including:

• - Chronic fatigue
• - Muscle and joint pain
• - Cognitive impairment (memory and concentration difficulties)
• - Skin rashes and hair loss
• - Dry eyes and dry mouth
• - Gastrointestinal problems
• - Increased susceptibility to infections

Scientific Evidence and Controversy: The relationship between silicone breast implants and systemic illness has been the subject of extensive research and debate. Several large-scale studies and reviews by reputable organizations, including the Institute of Medicine (now the National Academy of Medicine) and the U.S. Food and Drug Administration (FDA), have found no conclusive evidence linking silicone breast implants to autoimmune diseases or the broad array of symptoms described by some as "silicone disease."

However, some individuals with silicone breast implants continue to report experiencing these health issues, leading to ongoing debate and further research into what is sometimes referred to as "breast implant illness" (BII). BII encompasses a wide range of systemic symptoms reported by patients with either silicone or saline breast implants, not attributed to a specific autoimmune or systemic disease.

Medical Response and Recommendations: Due to the reported symptoms, some individuals choose to have their breast implants removed. Some report an improvement in symptoms after removal, while others do not. Medical professionals and researchers continue to study breast implants' potential effects on health to better understand the experiences of affected individuals.

The FDA recommends that individuals with breast implants monitor their health and implants, be aware of the signs of complications, and regularly consult with their healthcare providers. They also emphasize the importance of informed consent, ensuring that individuals considering breast implants are fully informed of the potential risks and benefits.

While "silicone disease" as a distinct medical syndrome is not recognized, the experiences of those reporting symptoms are taken seriously by the medical community, and ongoing research aims to provide clearer answers and guidelines for care.

Silicone prosthesis infection, what causes it?

An infection related to a silicone prosthesis, like a breast implant, can occur when bacteria or other pathogens infiltrate the area around the implant. This can happen during the surgical implantation process or postoperatively, even years after the surgery. The risk of infection is a concern with any type of surgery, and specific factors contribute to the risk associated with silicone prostheses. Here are the primary causes and contributing factors to silicone prosthesis infections:

Surgical Procedure: The most common time for bacteria to access the surgical site and potentially cause an infection is during the surgical procedure itself. Despite sterile techniques and precautions, the risk of contamination can never be entirely eliminated.

Contamination During Surgery: Bacteria from the skin's surface or the surgical environment can come into contact with the implant or the surgical site, leading to infection.

Biofilm Formation: Bacteria can adhere to the surface of the silicone implant and produce a biofilm, a protective layer that makes it difficult for the body's immune system and antibiotics to eradicate the infection. Biofilm-associated bacteria are a leading cause of chronic infections related to prostheses.

Postoperative Care: Improper postoperative care, including inadequate wound care, can increase the risk of infection. It's crucial to follow all post-surgery care instructions provided by the healthcare team to minimize this risk.

Immune System Status: Individuals with weakened immune systems, whether due to medical conditions (such as diabetes or immune-suppressing diseases) or certain medications, are at a higher risk of developing infections.

Subsequent Surgical Procedures: Any additional surgeries, especially those involving the same area as the prosthesis, can increase the risk of introducing bacteria and causing an infection.

Capsular Contracture: While not a direct cause of infection, capsular contracture (the formation of tight scar tissue around the implant) can complicate an existing infection or make it more challenging to treat.

Symptoms and Treatment: Symptoms of a silicone prosthesis infection can include redness, swelling, pain, fever, and discharge from the surgical site. If an infection is suspected, it's crucial to seek medical attention promptly. Treatment typically involves antibiotics to fight the infection. In some cases, especially if the infection does not respond to antibiotics or if there is a biofilm present, surgical removal of the implant and infected tissue may be necessary.

Preventive measures, including meticulous surgical technique, careful patient selection, and thorough pre- and postoperative care, are key to minimizing the risk of infection associated with silicone prostheses.

Rupture of the breast prosthesis, is it possible?

Yes, the rupture of a breast prosthesis is possible and can occur with both saline and silicone gel-filled implants. A rupture happens when the outer shell of the implant breaks or develops a tear, leading to the leakage of the filling material. The causes, symptoms, and management of a rupture can vary depending on the type of implant and the nature of the rupture.

Causes of Prosthesis Rupture

- Wear and Tear: Over time, the implant's shell can weaken and eventually rupture due to the natural aging process of the material.

- Physical Impact: Traumatic events, such as a car accident, forceful impact during sports, or a fall, can cause the implant to rupture.

- Surgical Error: Improper handling during implant surgery or during subsequent surgical procedures on the breast can damage the implant.

- Capsular Contracture: Severe capsular contracture, where the scar tissue that naturally forms around the implant contracts and squeezes it, can sometimes lead to rupture.

- Overfilling or Underfilling: In the case of saline implants, incorrect filling (either too much or too little saline) can stress the shell and lead to rupture.

Symptoms of Rupture

- Saline Implants: A rupture in saline implants typically becomes noticeable fairly quickly as the saline solution leaks out and is absorbed by the body, leading to a noticeable decrease in size and change in shape of the affected breast.

- Silicone Implants: Silicone implant ruptures are often referred to as “silent ruptures” because the silicone gel may remain within the implant capsule or the surrounding tissues, making it less noticeable. Some women experience symptoms such as pain, firmness, swelling, or changes in breast shape, but others may not notice any symptoms.

Diagnosis and Management

- Diagnosis: For silicone implants, regular monitoring through MRI scans is recommended to detect silent ruptures. For saline implants, a rupture is usually evident through physical examination.

- Management: The recommended treatment for a ruptured implant is surgical removal, possibly accompanied by replacement with a new implant. In the case of silicone implants, any leaked silicone gel that has escaped the capsule will also be removed during surgery.

It's important for individuals with breast implants to have regular follow-up appointments with their healthcare provider. They should also be aware of the signs of a rupture and seek medical advice if they suspect their implant has ruptured. Early detection and management of a rupture can help prevent further complications.

Contracture: when does rejection of the silicone prosthesis occur?

Capsular contracture is not technically a "rejection" of the silicone prosthesis by the body, but rather a common complication that can occur with breast implants, both saline and silicone. It involves the formation of a thick, fibrous capsule of scar tissue around the implant, which can contract and squeeze the implant, leading to various degrees of firmness, shape distortion, discomfort, or pain in the breast. This process can occur at any time but is more common in the months following the implant surgery.

Causes and Risk Factors

The exact cause of capsular contracture is not fully understood, but several factors may increase the risk:

- Bacterial contamination at the time of surgery, which may lead to a subclinical infection and an increased immune response.

- Hematoma or seroma (accumulation of blood or fluid around the implant) following surgery, which can lead to inflammation and scar tissue formation.

- Implant placement and type: Subglandular placement (above the chest muscle) and certain types of implant surfaces may have higher rates of capsular contracture.

- Previous radiation therapy to the chest area can increase the risk.

- Genetic factors: Some individuals may be more prone to developing excessive scar tissue.

Stages of Capsular Contracture

Capsular contracture is classified into four grades, according to the Baker scale:

- Grade I: The breast is normally soft and appears natural in size and shape.

- Grade II: The breast is a little firm but appears normal.

- Grade III: The breast is firm and appears abnormal.

- Grade IV: The breast is hard, painful to the touch, and appears abnormal.

Prevention and Treatment

While there's no guaranteed way to prevent capsular contracture, certain surgical techniques and post-operative practices can reduce the risk:

- Antibiotic prophylaxis to minimize bacterial contamination.

- Using textured implants may reduce the incidence compared to smooth implants, although the choice of implant type depends on individual factors and surgeon preference.

- Submuscular implant placement (under the chest muscle) has been associated with a lower risk of contracture compared to subglandular placement.

- Post-operative massage and breast exercises might be recommended by some surgeons to keep the capsule flexible, although its effectiveness is debated.

Treatment for capsular contracture typically involves surgery to remove the scar tissue and often to replace the implant. In some cases, changing the implant placement (e.g., from subglandular to submuscular) may be recommended. In severe cases, some individuals may opt for implant removal without replacement.

It's essential for individuals with breast implants to have regular follow-up care and to report any changes in the feel or appearance of their breasts to their healthcare provider promptly. Early intervention can help manage symptoms and prevent progression.

Can you have a mammogram with a silicone implant?

Yes, you can have a mammogram with a silicone implant, but it's important to inform the mammography technician that you have breast implants before the examination. Breast implants can obscure mammogram images because the silicone or saline within the implant may hide some of the breast tissue, making the detection of breast cancer more challenging.

To accommodate this, technicians use special techniques and additional views called implant displacement views or Eklund views. These techniques push the implant back against the chest wall and pull the breast tissue forward, allowing for a clearer view of the breast tissue in front of the implant. This method improves the ability to detect any abnormalities within the breast tissue.

However, there's a slight risk that the pressure applied during the mammogram could cause the implant to rupture, although this is rare. The benefits of mammography, a key tool in breast cancer screening, generally outweigh this minimal risk.

When do I need to change my Breast Prosthesis?

The need to replace or change a breast prosthesis, such as a silicone breast implant, can arise for various reasons. While modern breast implants are designed for durability, they are not considered lifetime devices. Knowing when to consider replacing them is important for maintaining your health and satisfaction with the results. Here are some situations when you might need to change your breast prosthesis:

Implant Rupture or Leakage: If an implant breaks or leaks, it needs to be replaced. Silicone implant ruptures may be "silent," meaning they don't always present immediate symptoms, so regular monitoring through MRI or ultrasound is recommended. Saline ruptures are noticeable due to a visible decrease in breast size.

Capsular Contracture: This occurs when the scar tissue that naturally forms around the implant tightens and squeezes the implant, causing discomfort or altering the appearance of the breast. Severe cases may require surgery to remove the capsule and replace the implant.

Cosmetic Concerns: Over time, you may decide that you want a different size, shape, or type of implant due to changes in preference or body shape. Additionally, aging and gravity can affect the appearance of breasts, leading to a desire for a change or a lift.

Implant Displacement or Malposition: Implants can sometimes shift from their original position, leading to asymmetry or an unnatural appearance. Surgery may be needed to adjust or replace the implants.

Breast Tissue Changes: Pregnancy, weight fluctuations, and aging can alter the breast tissue surrounding the implant, potentially necessitating a change in the implant or additional surgery to achieve the desired aesthetic outcome.

Device Complications: Although less common, issues like implant wrinkling, rippling, or folding can occur, which might prompt a desire for replacement.

Health Recommendations or Concerns: New information or recommendations from health authorities or your physician about the type of implant you have may lead to a decision to replace your implants.

Lifespan of the Implant: Manufacturers typically suggest that breast implants can last around 10 to 20 years, but this can vary widely among individuals. Regular check-ups with a healthcare provider can help determine the condition of the implants and whether they should be replaced.

It's essential to have regular follow-ups with your surgeon or healthcare provider after getting breast implants. These visits can help detect any potential issues early and keep you informed about the health and status of your implants. If you experience any discomfort, changes in breast appearance, or concerns about your implants, consult with a qualified plastic surgeon to discuss the best course of action.