Ask the Surgeon: Are Silicone Breast Implants Safe?

Ask the Surgeon: Are Silicone Breast Implants Safe?

Huge advancements in breast implant technology have made today’s silicone breast implants both more natural in look and feel, as well as extremely safe. Dr. Ali has used performed breast implant surgery using silicone implants with safe and natural results on thousands of women in Oakland County and across the metro Detroit area.

In this article Detroit area board certified plastic surgeon Dr. Ali discusses the history and the safety of silicone breast implant surgery.

FDA Approval of Breast Implants

Both saline and silicone breast implants are FDA approved, meaning that the US Food and Drug Administration considers them safe for breast augmentation and breast reconstruction. FDA-approved implants undergo extensive testing before approval to demonstrate reasonable assurance of safety and effectiveness.

The FDA has approved implants for increasing breast size, reconstruction after breast cancer surgery, and to correct or improve developmental defects or the result of a previous surgery. Additionally, research on the safety and effectiveness of both types of breast implants is always ongoing, as well, ensuring that improvements in breast implant technology are continually being made.

History of Silicone Breast Implant Surgery

Silicone implants were first used by breast surgeons in 1964 with new and imperfect technology. So, back then, some patients experienced complications. As a result, in 1992 the Food and Drug Administration (FDA) temporarily recommended that silicone implants be removed from use.

However, in 1999, the National Academy Institute of Medicine issued a report stating that diseases such as connective tissue disorders, cancer, neurological diseases, reproductive problems, or other systemic complaints or conditions “are no more common in women with breast implants than in women without implants.”

These studies also showed that there was no evidence of long-term autoimmune problems in women who underwent augmentation with silicone breast implants.

And, other exhaustive studies have shown that silicone breast implants actually have complication rates that are the same as, or in some cases lower than, saline implants.

So, in 2006 the FDA cleared silicone breast implants cosmetic use in women aged 22 and older. By 2010 breast implants were the most popular plastic surgery in the United States – with 62% of implants being silicone.

Do Breast Implants Cause Cancer?

Studies by the National Cancer Institute have also proven that there is no relationship between breast implants and breast cancer.

In the United States, approximately 1 out of 9 women (11%) will develop breast cancer. This percentage is the same for women with and without breast implants.

Today’s Silicone Breast Implant Surgery is Safe

Statistics from the American Society for Aesthetic Plastic Surgery state that roughly 1 in every 26 women in the US has breast implants – meaning that 4% of US women have improved their appearance with breast implants. In fact, about 300,000 women in the United States alone undergo breast implant surgery every year!

Doctor Ali, uses Mentor MemoryShape Gel Breast Implants – known for their natural look, realistic feel and their unparalleled safety record. Mentor Worldwide LLC, the developer of these implants and part of the Johnson & Johnson Medical Devices companies, recently announced the publication of a 10-year clinical study involving 955 breast augmentation patients in the U.S.

That 2018 study  highlighted the safety of MENTOR MemoryShape Gel Breast Implants, reporting:

  • High patient and surgeon satisfaction rates
  • Low capsular contracture, rupture and complications rates
  • No reported cases of breast implant-associated cancer

Complications of Silicone Breast Implant Surgery

As with any surgery, there is always a small risk of complication.  Infection is a risk with any surgery that can be greatly reduced with proper surgical procedures and meticulous aftercare.

Local complications and adverse reactions can also include capsular contracture, reoperation, removal, and implant rupture. However, these risks are very rare when the silicone breast implant surgery is performed by a skilled board certified plastic surgeon like Dr. Ali.

What Happens When a Breast Implant Breaks (Ruptures)?

Because of today’s improved materials from which breast implants are made, a rupture (break) in the breast implant is a very rare occurrence. However, even when a breast implant “pops” the situation is not immediately dangerous at all. What happens when a breast implant ruptures will depend upon whether the breast implant is saline or silicone.

If a saline breast implant ruptures, the “salt water” that it is filled with will simply leak out – and the implant will rapidly deflate. The body will then absorb the leaked saline solution. Since salt is a natural substance found in the body there are no health risks. However, the woman will need surgery to remove the deflated silicone shell, and replace it with a new implant so that her breasts are the same size.

It is harder to tell if a silicone breast implant ruptures. Patients you might not notice a silicone leak right away — or ever — because it is thick and leaks very slowly. The small amount of free silicone then generally tends to remain trapped in the fibrous tissue (capsule) around the implant.

Despite some “myths” to the contrary, leaking silicone gel does NOT cause disease or illness. Leaking silicone does NOT cause breast cancer, reproductive problems or arthritis. However, if you become aware of a leaking silicone breast implant Dr. Ali will recommend that you have it removed and replaced. This is because, over time, a ruptured silicone breast implant may cause breast pain, breast thickening, or changes in the shape or size of the breast.

Detroit Area’s Top Breast Implant Surgeon

Dr. Ali is a Detroit area double board certified Birmingham breast implant surgeon who has performed breast augmentation surgery on thousands of women in the metro Detroit area, including Birmingham, Troy, Rochester Hills, West Bloomfield, and across Oakland County. He utilizes the latest techniques and best, state-of-the-art breast implant technologies and procedures – to ensure that your results are as safe as they are beautiful. Doctor Ali will be happy to offer you a consultation to answer all of your questions at his Birmingham office.

Feel beautiful inside and out, with breast implant surgery. And remember, financing options are also available.

Detroit Area Breast Implant Surgeon Consultation: 248-335-7200

How to Decide if You Should Have Breast Implant Surgery

How to Decide if You Should Have Breast Implant Surgery

If you are one of the millions of women who are dissatisfied with the size, shape, position, symmetry and/or the proportion of their breasts, deciding to get breast implants is an important personal decision.  Detroit area board certified plastic surgeon Doctor Ali has helped thousands of women decide if breast implants are right for them, by carefully explain the pros and cons.

In this article we give you some general information to help you make an informed choice.  However, since every women is different, Dr. Ali offers a  breast implant consultation to help you decide if breast implants are a good option for you.

Benefits Associated With Breast Implants

According to recent clinical and psychological studies, the vast majority of women who have undergone breast implant surgery have universally reported very high levels of satisfaction with their body image and the shape, feel, and size of their implants.

In his Detroit plastic surgery practice, Doctor Ali prefers a type of breast implants called MemoryShape™ Breast Implants. This type of implant is not only more natural looking than older breast implants, but also feels more realistic. MemoryShape™ Breast Implants come in a wide variety of shapes, sizes and “profiles” so that they can be matched to the patient’s body – giving her the most beautiful ideal proportions.

In a core study conducted by Mentor, the maker of the MemoryShape™ Breast Implants, 97% of the 373 primary breast augmentation patients who answered a patient satisfaction survey indicated they would make the same decision to have the breast implant surgery!

Breast Implant Statistics

Breast augmentation has continued to be the single most popular cosmetic surgeries in the US since 2006. According to the American Society of Plastic Surgeons in 2019, there were 299,715 breast augmentation procedures performed across the United States alone. This makes it even more popular in the US than liposuction!

Plastic surgeons believe that there are several reasons breast augmentation continues to be the#1 cosmetic surgery:

#1. New technologies in breast implants have made them safer than ever

#2. The cost of breast implant surgery has become more affordable in recent years

#3. Celebrities & social media have removed the stigma from breast implant surgery

#4. Women feel more empowered to take control of their bodies

#5. New surgical techniques have reduced risk and downtime of breast implant surgery

#6. New breast implant designs look more natural

#7. New breast implant materials feel more realistic

Age and Breast Implants

The FDA does not recommend breast implants for patients under 18, and board-certified plastic surgeons won’t perform breast augmentations on women under 22 since breast tissue isn’t considered fully developed until that time.

But women in good health of all ages of 22 and beyond can enjoy the benefits of breast implant surgery. In fact, approximately 7,000 women over the age of 55 get breast implants every year.

Whether breast augmentation is right for you depends on your overall general health, underlying medical conditions, lifestyle, emotional state, body type, breast size/ shape before surgery, as well as your appearance goals after surgery.

Breast Implant Before & After

One of the best ways to decide if breast implants are right for you, is to see the results beforehand! Dr. Ali now offers advanced Vectra 3D computer imaging that can show you what your implants will look like before you get them!

Additionally, you can look at our extensive gallery of breast augmentation Before & After photos, to see what a big difference in appearance breast implants can make!

Top Detroit Breast Implant Surgeon

The vast majority of women who choose to get breast implants say that their augmented breast(s) help them be more self-confident, feel better about their bodies, and give them a greater feeling of well-being.

Detroit area board certified plastic surgeon Doctor Ali offers a breast implant consultation to help you learn about your options and decide if breast implants are a good option for you.

Detroit Area Breast Implant Consultation: 248-335-7200

gummy-bear-breast-implants

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Choosing the Right Breast Implants: FAQs

Choosing the Right Breast Implants: FAQs

In this article Troy, MI area double board certified breast implant surgeon Dr. Ali answers some commonly asked questions about choosing breast implants.

How do I know if I should have my implants placed over or under the muscle?

Generally, you should choose submuscular (under the muscle) breast implant placement if you have saline implants, a smaller amount of natural breast tissue, or a strong family history of breast cancer.

Typically, you should choose subglandular (over the muscle) breast implant placement if you want silicone implants, have a larger amount of natural tissue, or require a breast lift.

How do I know if I need a breast lift?

Dr. Ali will offer you a consultation to determine if you will also need a breast lift at the time of your implants. However, one way to get an idea if you need a breast lift is to stand in front of a mirror and look at your nipples in relation to the natural crease beneath your breasts.

If your nipples sit lower than your breast crease, adding breast implants without a breast lift to remove excess skin will generally make them more saggy – so you will probably need a breast lift.

Should I get round or teardrop-shaped implants?

Dr. Ali will offer you a consultation to help you determine which shape of breast implants are best for you. However, generally, round implants are the most commonly used implants. Round implants are totally symmetric so that their “orientation” (placement location) is always even and symmetric. Round implants are also less expensive than teardrop implants.

Anatomic or teardrop implants, on the other hand, are not symmetrical, with a greater projection at the bottom of the implants than at the top. So in some women, they may have a tendency to rotate causing problems.

Additionally, keep their rounded shape making them look somewhat more natural when you are lying down.

Will I get more cleavage from a breast implants?

Yes, breast implants can give you more cleavage. However, it’s important to that increasing the size of your breasts is not what gives you cleavage. Cleavage is a result of the width of your chest and how close your breasts are together – not how big they are.

If your breasts are set wide on your chest, you will have more fullness after your implants, but not more cleavage. On the other hand, if your body is narrow below your shoulders and your breast implants are placed close together, you can achieve greater cleavage even with a small implant.

What cup size should I choose?

Women tend to think of breasts in terms of cup sizes, because that is how we buy our bras. But cup size is a very subjective measurement: everyone wears their bras differently and every bra manufacturer makes them differently. A woman may be a 36C in one bra and a 34D in another.

Breast implant sizes are actually measured in cc’s. Implants range from 120 to 960 cc, with 300 to 400 cc being the most common range. Implants also differ according to their height and diameter.

Your breast implant size should be proportionate to your body in both size (number of cc’s), projection (height) and width. For example, a 200cc implant may look large enough on a petite woman with a narrow chest, while it would look small on a tall woman with a wider chest area.

Dr. Ali will work closely with you during your consultation to determine the most appropriate implant size for you.

Top Troy Area Breast Implant Surgery

Dr. Ali is a double board certified plastic surgeon, who has helped thousands of women get the beautiful breasts they want with breast implant surgery. He will offer you a consultation so you can understand what the best surgical options are for you. He will take the time to carefully answer all of your questions, and make sure that you have an understanding of the best techniques for achieving your appearance goals.

Troy Area Breast Implant Surgery Consultation: 248-335-7200

Choosing Breast Implants: Shape is More Important Than Size

Breast Implants: Why Shape Is More Important Than Size  –

Breast augmentation surgery, is one of the top plastic surgery operations performed. One of the biggest decisions faced by women considering breast augmentation surgery is what size is right for you.

Board certified plastic surgeon Dr. Ali has performed several hundred breast implant surgeries, and is an expert at helping his Troy, MI area patients choose the most beautiful breasts for their body. In this article he’ll discuss how to go about making that important choice.

Don’t Think of Breast Implants in Terms of Bra Size

Speaking about specific cup sizes is not a good way to describe a patient’s desired size in the most general of terms. To  begin with, all bra manufacturers are different. Victoria’s Secret, for example, tends to run small, so you’d wear a larger cup size at Victoria’s Secret than at Lane Bryant. As there is no standardization of sizes in the bra industry, you could very well be a 36C in one style and a 34D in another.

A more accurate measurement of your breast size is to measure them in cc’s. The most commonly selected breast implant size ranges somewhere within  300 to 400cc, although breast implants can range anywhere from 120cc to 960cc. Your ideal size will be determined by the shape of your frame and body type. What appears large on a petit woman might look comparatively small on a taller woman.

The amount of breast tissue you began with prior to your breast augmentation surgery will also factor into your implant size. Dr. Ali will work closely with you to help you determine what size implant is right for you.

Shape is More Important than Size in Breast Implants

The most important thing to concern yourself with is overall shape. Generally, women desire a full look that is still proportionate to their body. In order to achieve this, your frame size, height, and weight must all be taken into consideration. There are many choices when it comes to breast implant shape. in addition to choosing between round and teardrop shaped implants, you will need to select the “projection” of the implant from your body.

During the consultation process, our patients are given a bra to wear within which we place a series of implants of varying shape and size. This helps you visualize what you’ll look like following your breast implant surgery, and aids in Board Certified Plastic Surgeon Dr. Ali determine how best to meet your needs.

Bigger Isn’t Necessarily Better in Breast Implants

While bigger breast implants are the right option for some women, there are numerous considerations all patients should consider prior to their breast augmentation surgery. Larger implants can be somewhat more obvious, and will also be heavier than a smaller implant. If you’re a particularly athletic person, smaller implants may be a better fit for your lifestyle.

But be sure to make a choice that feels right for you and makes you as comfortable in your own skin as possible.

Breast augmentation is the specialty of Board Certified Plastic Surgeon Dr. Ali, who, along with his entire staff, will aid you in determining what size is right for you. If you’re thinking about getting breast augmentation surgery, call us today for a consultation.

Top Troy, MI Area Breast Implant Surgery

Dr. Ali is a double board certified plastic surgeon, who has helped thousands of women get the beautiful breasts they want with breast implant surgery. He will offer you a consultation so you can understand what the best surgical options are for you. He will take the time to carefully answer all of your questions, and make sure that you have an understanding of the best techniques for achieving your appearance goals.

Troy, MI Area Breast Implant Surgery Consultation: 248-335-7200

Why Today’s Breast Augmentation Surgery is Better

Why Today’s Breast Augmentation Surgery is Better

It has been more than fifty years since the first breast augmentation surgery was performed, using silicone implants. Today, breast augmentation surgery is the number one most popular cosmetic surgery in the United States – with 300,000 breast augmentations performed in 2017 alone. This represents a 3% increase over 2016.

One of the reasons breast implant surgery continues to grow in popularity is the improvements made in both the implant materials and the surgical procedures over the last several years.

In this article we share 3 reasons why today’s breast augmentation surgery is better, making it easier than ever before to get the breasts you have always wanted.

While there are lots of different factors that go into getting the beautiful results you want, these three benefits of modern breast augmentation surgery make it

New Breast Augmentation Materials are More Natural

Substantial improvements have been made recently in breast implant technologies – making them both more natural and more durable than ever before.

In 2017, silicone breast implants were used in 87% of all breast augmentation surgeries. While saline implants accounted for 13% of all breast augmentations

The new generation of so-called “gummy bear” breast implants are shaped like a teardrop. The sloped shape – with more fullness at the bottom – is virtually indistinguishable from the contours of a natural breasts.

Made from High-strength cohesive (HSC) silicone gel, these newer implants remain soft and natural-feeling to the touch – just like real breasts.

They even “squish” when pressed against another person – when hugging or being intimate rather than feeling hard like previous breast implants.

New Breast Implant Materials are Sturdier & More Stable

High-strength cohesive (HSC) silicone gel is also breakthrough technology in breast implants because it is the strongest type of silicone on the market. This means that the breast implants far sturdier than they were before, and less prone to breakage or leakage.

When earlier versions of silicone breast implants were damaged the clear gel inside would slowly create leak into the body. Newer silicone implants holds their shape and do not leak if ruptured.

New Breast Augmentation Surgical Techniques are Better

Breast surgeons now have a much better and  more advanced understanding of how to minimize complications from breast augmentation surgery.

With new advances in surgical techniques there is lower risk of infection, capsule contracture, rippling and other complications.

For example, the Keller funnel now allows the surgeon to “fold and slip” the silicone implant into place (kind of like a pastry bag) through a smaller incision. Not only does this procedure minimize scarring, but it also reduces the risk of infection.

Detroit Area Breast Augmentation Surgeon

If you have questions about the latest developments in breast implant surgery, please schedule a consultation with award-winning Detroit area plastic surgeon Dr. Ali.

The vast majority of women who choose to get breast implants say that their augmented breast(s) help them feel more self-confident, feel better about their bodies, and/or give them a greater feeling of well-being.

Detroit area board certified plastic surgeon Doctor Ali offers a breast augmentation consultation to help you learn about your options and decide if breast implants are a good option for you.

Detroit Area Breast Augmentation Consultation: 248-335-7200

How Plastic Surgeons Make Breast Implants Look Natural (Part 2)

How Detroit Plastic Surgeon Dr. Ali
Makes Breast Implants Look Natural (Part 2)

All breast implant surgery alters the size and shape of a woman’s breasts – but it is the skill of the plastic surgeon that results in the breasts looking natural. Women who were dissatissfied with their breast and opted for breast implants almost universally experience greater self-confidence while looking and feeling their best.

Detroit plastic surgeon Dr. M. Azhar Ali has performed more than 2,500 breast augmentations at his Amae Plastic Surgery Center.

As a double board certified plastic surgeon,  Doctor Ali has become an expert at creating realistic looking and feeling breast implants. In this two part article he shares the recommendations he gives to his patients who desire more natural-looking breast implants.

CLICK HERE for PART 1 of Making Breast Implants Look Natural

Method of Breast Implant Surgery

The way the breast implants are surgically implanted can also affect how natural and attractive that the new breasts look and feel, according to Detroit area plastic surgeon Dr. Ali.

For example, he typically suggests that going under the armpit and placing the implant under the muscle will give the most realistic appearance. However, the type of procedure he uses depends on the woman’s natural breast size and shape, as well as the amount of existing breast tissue.

The size of the implant also matters. For example, larger breast implants cannot be placed by way of the armpit; they must be inserted the through the fold of the breast or areola.

Breast Implant Type

Dr. Ali says that while silicone and saline are both FDA approved, silicone gel implants tend to feel more natural when compared to saline. Silicone gel tends to mimic the natural consistency of breast tissue.

Doctor Ali typically prefers Mentor MemoryShape® Breast Implants for their natural shape, feel, and excellent variety of sizes and silhouettes. These emulate the silhouette of a natural breast, with their teardrop shape. ANd they are filled with a cohesive gel uniquely formulated to retain this natural breast shape.

Realistic Breast Implant Expectations

“During a consultation, I will ask the patient what she expects from breast implants,” says Dr. Ali. “Does she want larger breasts, or to fill them out following childbirth? How pert does she want them to be, and what does she want her cleavage to look like?”

Detroit area plastic surgeon Dr. Ali advises all patients considering breast implants to keep their expectations realistic if they want more natural looking breas implants.

To help with expectations, Dr. Ali recommends that patients bring to their consultation a series of photographs that depict the outcome they expect. Dr. Ali also offers his patients several before and after images that can help his patients visualize what the after effects will look like.

He warns that every woman’s body is different and that a certain size and type of implant may look different on one woman when compared to another. That’s where the doctor’s experience and expertise come into play.

A top plastic surgeon can recommend the best breast implants type, size and method to ensure the patient’s satisfaction. Choosing a highly experienced and qualified board certified surgeon like Doctor Ali is the best way to ensure natural looking and feeling breast implants.

Top Detroit Area Breast Implant Surgeon

If you have questions about the latest developments in natural looking and feeling breast implant surgery, please schedule a consultation with award-winning Detroit area plastic surgeon Dr. Ali.

The vast majority of women who choose to get breast implants say that their augmented breast(s) help them feel more self-confident, feel better about their bodies, and give them a greater feeling of well-being.

Detroit area board certified plastic surgeon Doctor Ali offers a breast implant consultation to help you learn about your options and decide if breast implants are a good option for you.

Detroit Area Breast Implant Consultation: 248-335-7200

Which Celebrities Admit to Breast Enhancements?

Celebrity Breast Enhancement Quotes

If you’re considering having breast enhancement surgery, you’re in good company. Plenty of Hollywood’s most famous celebrities have already done so – to improve their careers and their self-esteem.

Today we’ll take a look at some of the entertainment industry’s most outspoken advocates of breast implant surgery. Some of them may surprise you!

Anna Faris on Her Breast Enhancement

When faced with the decision of whether or not to proceed with breast enhancement surgery, adorable actress Anna Faris stated it all came down to one basic question: how she would look in a bikini.

According to an interview with Woman’s Health, the Overboard and House Bunny star stated that while she, “never, ever thought” about getting breast enhancement surgery, she changed her mind when she turned 30.

“I was always a negative-A cup, so when I was 30, I was getting a divorce, I had just finished House Bunny, and I’d sold another movie, all of these new things were happening to me, so I got my breasts done.” Regarding how she felt regarding her choice to get breast enhancement surgery, Faris stated that, “it was … awesome.”

“I never, ever thought I’d do something like that,” she went on, explaining that she “always thought plastic surgery was caving to ‘the man,’ you know? But it came down to a really simple thing: I wanted to fill out a bikini.”

Kourtney Kardasian on Her Breast Enhancement Surgery

In an episode of Keeping Up with the Kardiashians, Kim Kardashian casually let it slip that her sister, Kourtney, had undergone a breast enhancement surgery in her younger years.

“I have had breast implants,” Kourtney Kardashian stated in a 2010 episode of Nightline. “But it’s so funny, ‘cause it’s not a secret, I could care less” who knows.

Iggy Azalea on Her Breast Enhancement Surgery

“I love them so much I had to talk about them…” the Australian rapper told E! about her breast enhancement in a 2015 interview.

“I’d feel better not to have some secret,” she said. “It’s much freer to say it and then you don’t have to worry someone will dig it up.”

NeNe Leakes on Her Breast Enhancement Surgery

In an interview with People, the Real Housewives of Atlanta star stated that she has had liposuction, a nose job, and breast enhancement surgery (with a lift!)

“I still wanted to look like NeNe, the black woman that I am, but a better version.”

Kaley Cuoco on Her Breast Enhancement Surgery

When speaking with Woman’s Health Magazine, Big Bang Theory star Kaley Cuocostated that her breast enhancement surgery was, “the best thing I ever did.”

The actress went on to state that, “As much as you want to love your inner self, I’m sorry, you also want to look good…I don’t think you should do it for a man or anyone else, but if it makes you feel confident, that’s amazing!”

Naya Rivera on Her Breast Enhancement Surgery

In her book, Sorry Not Sorry, the former Glee star opened up about receiving breast enhancement surgery shortly after becoming an adult.

“People have a lot of opinions about plastic surgery, but more than 10 years after I got my boobs, they still make me happy when I look in the mirror.”

Best Detroit Breast Enhancement Surgery

Women who choose to get breast surgery – including breast enhancement surgery, breast lift surgeryor breast reconstruction surgery – universally report that their new breasts help them feel more self-confident, feel better about their bodies, and give them a greater feeling of well-being!

Top rated Detroit area board certified plastic surgeon Doctor Ali offers the same stunning breast enhancement results that the stars get in Beverly Hills.

Schedule a breast enhancement surgery consultation with Doctor Ali to learn about your options, and decide if breast enhancement surgery is right for you.

Detroit Area Breast Enhancement Surgery Consultation: 248-335-7200

History of Silicone Breast Implant Regulation (Part 1)

History of Silicone Breast Implant Regulation (Part 1)

Most board certified plastic surgeons, like Detroit’s Dr. Ali, now prefer silicone breast implants for their patients because of their natural look and feel, and excellent safety record.

In this two part article Detroit area breast implant surgeon Dr. Ali discusses the regulations that have affected silicone breast implants over the years – ensuring patient safety.

Silicone Breast Implant Regulation: 1960s

Gel-filled silicone breast implants were introduced to the U.S. in 1962, and in common use by 1964.

This new technology was imperfect at first. In large part this was due to lack of study or regulation on this new technology.

But thanks to advancements in technology, rigorous scientific testing, and intensive regulation by the FDA, silicone breast implants are now very safe.

Silicone Breast Implant Regulation: 1970s

Before 1976 breast implants were not highly regulated. In 1976 the U.S. Congress passed the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Under this law, breast implants were considered “Class II” (moderate risk) medical devices – and as such they had to comply with general controls and performance standards.

At that time the FDA reviewed new breast implants through a process called the 510(k) Premarket Notification process, like any other Class II products.

Silicone Breast Implant Regulation: 1980s

In the early 1980s, the FDA began to identify certain local complications and adverse outcomes of these older silicone breast implants. Some reports even described cancer and connective tissue disease in a small number of women with breast implants.

As concerns arose about the safety of silicone breast implants rose, the FDA reclassified breast implant into “Class III” (higher-risk), which requires premarket approval. Breast implant manufacturers now had to provide data demonstrating the breast implants were safe and effective BEFORE they could be sold.

CLICK HERE for Part 2 of The History of Silicone Breast Implant Regulation

Troy, MI Area’s Top Breast Implant Surgeon

Dr. Ali is a Troy area double board certified breast implant surgeon who has performed breast augmentation surgery on thousands of women in the metro Detroit area, including Birmingham, Troy, Rochester Hills, West Bloomfield, and across Oakland County. He utilizes the latest techniques and best, state-of-the-art breast implant technologies and procedures – to ensure that your results are as safe as they are beautiful. Doctor Ali will be happy to offer you a  consultation to answer all of your questions at his Birmingham office.

Feel beautiful inside and out, with breast implant surgery. And remember, financing options are also available.

Troy, MI Area Breast Implant Surgeon Consultation: 248-335-7200

History of Silicone Breast Implant Regulation (Part 2)

History of Silicone Breast Implant Regulation (Part 2)

Most board certified breast surgeons, like Detroit’s Dr. Ali, now prefer silicone breast implants for their patients because of their natural look and feel, and excellent safety record.

In this two part article Troy, MI area breast implant surgeon Dr. Ali discusses the regulations that have affected silicone breast implants over the years – ensuring patient safety.

CLICK HERE for Part 1 of The History of Silicone Breast Implant Regulation

Silicone Breast Implant Regulation: 1990s

In 1992, the FDA still had concerns that the breast implant manufacturers were not adequately addressing public concerns about certain complications. At that time a higher incidence of implant rupture and silicone leakage was being seen.

So, the FDA removed all silicone breast implants from sale in the US, and required all manufacturers to submit premarket approval applications that contained detailed data on safety and effectiveness.

However, in the meantime, the FDA did allow manufacturers to provide silicone breast implants for reconstruction after mastectomy, correction of congenital deformities, or replacement of existing implants. So, the manufacturers enrolled women who received silicone breast implants for medical (not cosmetic) purposes in performance and safety studies.

Then in 1999, the Institute of Medicine (IOM) released a detailed report compiling the results of all of these published and ongoing studies on breast implants, called Safety of Silicone Breast Implants.

This report concluded that there was no evidence that silicone breast implants caused systemic health effects such as cancer or autoimmune disease. And while it did identify rare local complications (which included rupture, pain, capsular contracture, disfigurement, infection, and repeat surgeries) silicone breast implants were now recognized as generally safe.

Silicone Breast Implant Regulation: 2000s

After years of studies and technological improvements, the FDA approved silicone gel-filled breast implants in November 2006.

As with any surgery, there is always a small number of possible local complications and adverse outcomes. However, the FDA concluded that the benefits and risks of breast implants were sufficiently well understood for women to make informed decisions about their use.

Initially, in 2006, the FDA only approved Mentor’s MemoryGel Silicone Gel-Filled Breast Implants and Allergan’s∗ Natrelle Silicone Gel-Filled Breast Implants – followed six years later by Sientra’s Silicone Gel Breast Implants.

Silicone Breast Implant Regulation: 2010s

Advanced technologies in breast implant look, feel and safety continued to be developed. And in 2013 Mentor’s MemoryShape and Allergan Natrelle 410 Highly Cohesive Breast Implants were approved.

Today these five breast implants remain the only 5 breast implants that are FDA approved for use in the US.

Troy, MI Area’s Top Breast Implant Surgeon

Dr. Ali is a Troy area double board certified Birmingham breast implant surgeon who has performed breast augmentation surgery on thousands of women in the metro Detroit area, including Birmingham, Troy, Rochester Hills, West Bloomfield, and across Oakland County. He utilizes the latest techniques and best, state-of-the-art breast implant technologies and procedures – to ensure that your results are as safe as they are beautiful. Doctor Ali will be happy to offer you a consultation to answer all of your questions at his Birmingham office.

Feel beautiful inside and out, with breast implant surgery. And remember, financing options are also available.

Troy, MI Area Breast Implant Surgeon Consultation: 248-335-7200