Breast Implantable prosthesis is a medical device that is implanted surgically in order to augment, reconstruct, or reshape the patient’s breast. This medical device is used for augmentation, reconstructive, and revision purposes. The implant is made up of silicone shells that contain either silicone gel or saline.
Breast implant safety is a critical topic for women to understand because implants are not lifetime devices and carry risks that can develop immediately or years after surgery. While generally safe, around 20% of silicone implants may require removal or revision within 8-10 years due to complications.
400K Women get breast implants in the US each year , 85% of patients today choose silicone over saline, 1000+Silicone implant case studies published by Dr. Stoker, 8th Gen Current generation of cohesive silicone implants
I take seriously, and I think it will be helpful to discuss breast implant safety in this blog post. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII).
A Brief History of Modern Breast Implants
Understanding where breast implants are today means understanding how far they have come. The first silicone gel implants were used in breast augmentation surgery in the 1960s. With every successive generation, the manufacturers have been making steady improvements in terms of safety, natural feeling, and durability of the implants.
1960s-Introduction of silicone gel implants in breast implant surgery.
1992-Restrictions were placed on silicone implants while comprehensive safety studies were being conducted. Saline implants gained favor during this time.
2006-Safety studies proved the safety of silicone implants. FDA lifted the ban on them, approving their usage for individuals who were at least 22 years old.
2011-The FDA identified a link between certain breast implants and BIA-ALCL, prompting further research and tighter monitoring.
2019 –Allergan voluntarily recalled its BIOCELL textured implants. Patients now have access to the 7th and 8th generation of cohesive silicone gel implants the safest and most advanced in history.
Today, women considering breast augmentation surgery have access to the most advanced implant options ever developed. At my practice in Marina del Rey, I use the latest FDA-approved silicone implants, including Sientra cohesive gel implants, which I have used in clinical trials and which are available only through board-certified plastic surgeons.
The Safety of Today’s Breast Implants
According to the American Society of Plastic Surgeons, about 400,000 women in the United States get breast implants every year. Around 300,000 of those women choose breast augmentation for cosmetic reasons, and 100,000 choose implants to reconstruct their breasts after they have mastectomies to treat or prevent breast cancer. The vast majority of these women experience no health issues related to having implants.
The older the implants, however, the more likely a complication can occur. This complication may be leakage or a condition such as capsular contracture when the capsule of scar tissue surrounding the implant becomes harder and squeezes the device. Capsular contracture can distort the implant’s appearance and cause pain.
The safety concerns that have generated the most recent discussion, however, are BIA-ALCL and BII. Let’s take a closer look at each of these conditions.
What is BIA-ALCL?
BIA-ALCL stands for breast implant-associated anaplastic large cell lymphoma. Although this cancerous tumor occurs in the breast region, it is not breast cancer. It is rather a form of rare cancer that affects the immune system, and which mostly develops in the capsule tissue or space around the implant rather than the actual breast tissues.
The first evidence of the association between BIA-ALCL and breast implants was reported by the FDA in 2011. However, several studies have shown that the occurrence of this disorder is still low. Most cases of BIA-ALCL are successfully treated when caught early.
Silicone vs. saline implants: what is the difference?
This is one of the first questions patients ask during a consultation and it is an important one. Both types are FDA-approved and widely used, but they have meaningful differences in feel, appearance, and suitability depending on your body type.
Silicone gel implants feel closer to natural breast tissue. They are less prone to rippling under the skin, which makes them especially suitable for women with less natural breast tissue. Modern cohesive silicone implants sometimes called “gummy bear” implants hold their shape even if the outer shell ruptures, because the gel is thick enough to stay in place. About 85% of patients today choose silicone for these reasons.
Saline implants are filled with sterile salt water. They have a long safety record and cost less than silicone. If a saline implant ruptures, the body safely absorbs the saltwater and the deflation is immediately visible, making it easy to detect. Saline implants are approved for patients aged 18 and older, whereas silicone gel implants are approved for those 22 and older.
It is essential to note that rupture of silicone implants occurs in what is called a “silent manner.” This means that the rupture may be invisible and unnoticeable. That is why the FDA advises that women who have silicone implants should undergo a routine MRI or ultrasound exam every two years as a precautionary measure.
The Safety of Modern Breast Implants
As per the American Society of Plastic Surgeons, about 400,000 women have breast implants implanted each year in the United States, with 300,000 for aesthetic purposes and 100,000 for breast reconstructive surgery.The vast majority of these women experience no serious health problems related to their implants.
That said, like any medical device, implants are not permanent and are not risk-free. The older an implant gets, the more likely it is that some kind of change could occur. This may be something relatively trivial, such as rippling of the implants, or something quite serious, such as capsular contracture, whereby the scar tissue around the implant thickens and contracts, leading to deformation and even pain. Capsular contracture is one of the most common reasons women return for implant revision surgery.
The two safety concerns that have received the most attention in recent years, however, are BIA-ALCL and breast implant illness. Let me explain both of these clearly.
Textured vs. Smooth Breast Implants
The surface of breast implants can be either smooth or textured. The majority of implants used in breast augmentation procedures are smooth, round implants. Anatomically shaped implants are textured to help keep them from rotating inside the implant pocket.
As the FDA continued to evaluate evidence of cases of BIA-ALCL in the U.S. and around the world, researchers found that the risk of BIA-ALCL is higher for textured implants versus smooth implants. The FDA specifically linked BIOCELL textured implants made by Allergan to the risk of developing BIA-ALCL. In July 2019, Allergan voluntarily agreed to remove these devices from the market. Because the risk was so low, the FDA did not recommend that women with these types of implants have them removed if they weren’t experiencing symptoms associated with BIA-ALCL.
BIA-ALCL symptoms: when to call your doctor
Breast implants of any type it is important to know the warning signs of BIA-ALCL. Contact your doctor promptly if you notice any of the following things in your Body:
- Unexplained breast enlargement
- Persistent breast pain
- A lump in the breast or armpit
- A skin rash on or near the breast
- Unusual hardening of the breast
- A large, sudden accumulation of fluid
These symptoms can appear months or even years after getting implants. Do not wait to see if they resolve on their own. Early diagnosis of BIA-ALCL is associated with much better outcomes. If you are not experiencing symptoms, continue your regular MRI or ultrasound monitoring every 2 years.
What Is BII?
The emergence of BIA-ALCL has also highlighted an unrelated condition called breast implant illness, or BII. This condition includes a collection of physical and emotional symptoms that women believe are linked to their breast implants. Researchers evaluating the link between implants and women with these symptoms have not defined BII as a specific diagnosis. The symptoms may occur at any time after getting implants, including years later.
These symptoms include:
- Joint and muscle pain
- Chronic fatigue
- Memory and concentration problems
- Breathing problems
- Sleep disturbance
- Rashes and skin problems
- Dry mouth and dry eyes
- Anxiety
- Depression
- Headaches
- Hair loss
- Gastrointestinal problems
- Skin rash
- Dry mouth and eyes
Even though it is uncertain whether breast implants cause these symptoms, several studies indicate that some women see most of their symptoms improve partially or completely after having their implants and capsules removed.
Implant complications to know
In addition to BIA-ALCL and BII, there are some other potential complications of breast implants that a woman should be aware of. None of these issues are linked to any particular manufacturer; they can happen in general. Here are two of the most frequent ones:
Capsular contracture: The scar tissue forms around the implant and makes it stiff and tight, causing hardness and pain in the area of your breasts. This is the most common reason for revision surgery.
Rupture or leakage: With age, the outer layer of the implant may get a hole. Ruptures of saline implants occur visibly, while ruptures of silicone implants may occur silently and need MRI to diagnose.
Implant rippling: The margins of the implant are either visible or palpable as ripples underneath the breast. More frequently seen in saline implants or women with less breast tissue.
Implant displacement: The position of the implant moves from where it is supposed to be. In some cases, it can be rectified without replacing the implant.
Sensory changes: Some patients may face temporary or permanent sensory alterations in the breast or nipples due to surgery
Breast implant safety checklist
Whether you are considering breast augmentation for the first time or already have implants, there are concrete steps you can take to protect your health and get the most from your results.
Choose a board-certified plastic surgeon with specific experience in breast augmentation not a cosmetic surgeon trained in another specialty
Ask your surgeon which implant type silicone or saline, smooth or textured is right for your body and goals
Get an MRI or ultrasound every 2 years if you have silicone implants even if you have no symptoms
Attend all scheduled follow-up appointments so any changes can be detected early
Contact your surgeon immediately if you notice any new breast swelling, pain, lumps, or skin changes
FDA’s breast implant risk page to stay informed the FDA updates this regularly as new data becomes available
Frequently asked questions
Are breast implants safe in 2025?
Yes ,today’s breast implants are the safest they have ever been. The current 7th and 8th generation of cohesive silicone gel implants are rigorously tested and FDA-monitored. The vast majority of patients experience no serious complications. As with any medical device, regular monitoring and choosing an experienced, board-certified surgeon significantly reduce your risk.
How long do breast implants last?
Breast implants are not considered lifetime devices. Most implants last 10 to 20 years, though some women keep them longer without issue. The older the implant, the higher the chance of a complication such as rupture or capsular contracture. Regular monitoring helps detect any changes early.
What is the difference between BIA-ALCL and breast cancer?
BIA-ALCL is not breast cancer. It is a rare cancer of the immune system found in the fluid or scar tissue around the implant not in the breast tissue itself. It is most strongly associated with textured implants and is typically very treatable when caught early. Breast cancer develops in breast tissue and is unrelated to implants.
Should I have my breast implants removed if I have no symptoms?
If you have no symptoms, removal is generally not recommended. The FDA advises monitoring with regular MRI or ultrasound scans every 2 years. If you have Allergan BIOCELL textured implants and are concerned, consult your surgeon but removal is a personal decision, not a blanket requirement
What is rapid recovery breast augmentation?
Rapid recovery breast augmentation is a specialized technique developed by Dr. Stoker that allows most patients to return to normal daily activities within 24 to 48 hours compared to the standard 2-week downtime. It uses precise muscle-sparing techniques and long-acting local anesthetics to minimize discomfort and accelerate recovery.
Can breast implants affect mammograms?
Yes , implants can make mammograms slightly harder to read. Always tell your mammography technician that you have implants before your scan. They will use special displacement techniques to image as much breast tissue as possible. Additional views may be needed. This does not mean you should skip mammograms they remain an important part of breast health monitoring.
What age can I get breast implants?
The FDA recommends that saline implants be used on those who are 18 years old or more, and that silicone gel implants be inserted into patients at 22 years old or above. This is a minimum requirement; your surgeon must also assess whether you’re mentally and physically ready for the operation.
Refrences
Stoker Plastic Surgery -https://www.drstoker.com/plastic-surgery/breast/breast-augmentation/
The American Board of Plastic Surgery-https://www.abplasticsurgery.org/
American Society of Plastic Surgeons-https://www.plasticsurgery.org/news/plastic-surgery-statistics
https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants