Are Silicone Breast Implants Safe?

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Dr. Sophie Bartsich is one of the top plastic surgeons in New York City. Her award-winning research is focused on cosmetic breast surgery and is dedicated to the development of better breast implants. Her recently published article, “Déjà Vu: Silicone Breast Implants Have A Complicated History, But Are They Safe Now?” explores the questions surrounding silicone implants through the eyes of her experience not only as a physician, but as a woman.

Dr. Bartsich refers to the recent findings of the The University of Texas MD Anderson Cancer Center’s Plastic Surgery Department, which conducted the most extensive study ever among women who have silicone breast implants. The purpose of the study was to judge the relationship between silicone and certain autoimmune disorders, as well as other chronic illnesses. By surveying women with the implants, the hope was to find out if they were more likely to develop these illnesses than women without silicone in their breasts. While the study’s results were slightly uncertain due to inherent weaknesses, the findings strongly indicated that the illnesses were in fact related to breast implants filled with silicone gel.

A Difficult Background

From the early 1960s to the 1990s, most breast augmentations were done using silicone gel implants. The soft contour and natural feel made them the easy, popular choice over saline implants. However, rising concerns about the effects of implant leakage and reports of silicone causing various illnesses led to the removal of silicone implants from the market until 2006. During this time, saline was the filler of choice for most breast augmentation patients. But, when silicone gel was finally reintroduced to plastic surgery consumers, women embraced it because the implants were safer and better than ever. Today, it is still a favorite option as the “gummy revolution” has further improved the safety of silicone implants.

A Surgeon’s Experience With Silicone Gel

Dr. Bartsich underwent her surgical training at some of Manhattan’s most prestigious academic institutions. She performed many cosmetic and reconstructive breast augmentations using different types of implants. During those years, there was just one design for saline implants – which basically made them feel and act like a water balloon. When it came to instruction about the safety of silicone gel implants, she recalls,

“We were taught that these implants should be periodically monitored for rupture, since a ruptured silicone implant often looks and feels no different than one that is intact. But there was not much concern for general wellness in these patients.”

The vast majority of breast augmentation patients were willing to deal with the bother of routine monitoring if it meant they could have a better looking implant. Dr. Bartsich describes her patients as “very aware and motivated women, highly active and pressed for time.” When consulting with patients interested in silicone gel implants, she explained the risk of silent rupture and the necessity of MRIs. When the question came up about how often the implants would need to be replaced, Dr. Bartsich admits there was no easy answer. Most of her patients still ended up choosing silicone gel implants over saline implants.

Gaining Deeper Perspective

Performing many different types of implant revision surgeries over the course of several years has given Dr. Bartsich a fresh perspective on the effects of silicone gel on the body. Witnessing first hand what happens to implants anywhere from 5-46 years old has allowed her to advise her breast augmentation patients wisely. She has even performed surgery on patients whose MRI results indicated their implants were obviously ruptured, when in reality they were perfectly intact. She says,

“I no longer tell patients, “If they’re not bothering you, leave them alone,” as I had been taught. And I no longer expect that the MRI has the answer; I trust my exam and clinical judgment… I treat the patient, not the problem.”

Are Silicone Implants Safe or Not?

Like other plastic surgeons, Dr. Bartsich is often asked about the safety of silicone breast implants. It’s a question she has spent time researching and talking about with her patients. Some women report vague symptoms of unwellness when they have silicone gel in their body after an implant breaks. Others say they “just felt better” after they had their silicone implants removed. It’s hard to ignore the recurring testimonials of women with silicone gel implants who have felt a negative change in their health. Dr. Bartsich says, “One would argue that where there’s smoke, there’s fire, but we still don’t have definitive proof of what the problem might be nor how deep it runs.”

Beauty Without Compromise

With the sticky history of silicone gel implants, it’s easy to see why women would be torn when trying to choose between the peace of mind offered by saline breast implants and the beauty of silicone implants. Dr. Bartsich has had the internal debate herself, “I always imagined that if there were a saline implant that looked and felt comparable to silicone, it would be very welcome in our community. The Ideal Implant, with a structured multi-chamber design, saline fill, and perky contour, provides that low-maintenance possibility.”

IDEAL IMPLANT® Structured Breast Implants are for women who want beautiful, natural-feeling augmented breasts without having to worry about keeping up with MRIs and the potential risks that come with silicone gel leakage. Many of Dr. Bartsich’s breast augmentation patients choose the IDEAL IMPLANT for those very reasons. She believes in educating her patients on all of their options for breast implants so they can make the decisions that best suit their needs.

We’ve Come So Far, But Questions Remain

The current market for breast implants has a wide variety of options. Silicone gel implants and saline implants have both come a long way in terms of safety, look, and feel. The IDEAL IMPLANT offers an alternative to each, addressing patients’ desires for both beauty and security. The fact that we are revisiting the potential health risks associated with silicone breast implants is enough to concern women and plastic surgeons alike. Dr. Bartsich says, “The truth is that if it were me, I wouldn’t want a ruptured implant in my body… And as a woman, I also know that sometimes not feeling well is hard to explain and even harder to prove.”

Dr. Bartsich continues her research to pursue the answers that her breast augmentation patients need to make informed choices. Her article, “Déjà Vu: Silicone Breast Implants Have A Complicated History, But Are They Safe Now?” considers the questions at the forefront of the minds of women considering breast implants. She states,

“As a surgeon, I try to keep current with the latest data so I can accurately represent the facts. As a woman, I always consider what I would want someone to tell or offer me if I were the one having the consultation. As a patient, I weigh the risks and benefits of every choice I make, and what it might mean in the future. And as a physician, I have to feel good about what I did for someone today.”

Considering breast implants in New York City? Contact Dr. Sophie Bartsich today to discuss your options. Simply call 212-717-9200, or visit www.doctorsophie.com. Dr. Bartsich’s office is located at 960 Park Avenue, New York, New York 10028. Call today for more information on IDEAL IMPLANT® Structured Breast Implants.

Why Choose IDEAL IMPLANT Breast Implants?

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Educate Yourself on Saline, Silicone Gel, and IDEAL IMPLANT® Structured Breast Implants

Before your breast augmentation, you should review your choices. You can choose your surgeon, type of incision, whether your implant is placed above or below the muscle, and, most importantly, what type of breast implant is used. Saline breast implants, silicone gel breast implants, and IDEAL IMPLANT breast implants all offer unique benefits and compromises. Before you meet with a board-certified plastic surgeon you should educate yourself on the different types of breast implants currently available. Knowing more about each type will help you make an informed decision and ensure you get the best outcome.

The History of IDEAL IMPLANT Breast Implants

The IDEAL IMPLANT Structured Breast Implant was created by Dallas-based board-certified plastic surgeon Dr. Robert Hamas. He explains, “The idea came from listening to my patients. I realized that women want a breast implant that combines the benefits of both saline and silicone gel implants without having to accept the well-known compromises associated with each of them.” After the initial idea was in place Dr. Hamas and his team started research and development. Dr. Hamas said, “over the years, our team has refined the implant design and manufacturing quality. We will soon complete our ten-year clinical trial with over 500 women.” The FDA and Health Canada approved the implant in November 2014 with sales beginning in September 2015. To review the FDA’s summary of safety and effectiveness data (SSED) visit this page. Since coming on the market the IDEAL IMPLANT has become a popular alternative to silicone gel because they offer the same beautiful results with added peace of mind.

Survey Data on Benefits and Compromises of Breast Implants

Breast implants offer women the opportunity to increase their self-esteem and love their bodies. But for some women this can come with a cost. Dr. Hamas’ patients were not alone in not wanting to accept the compromises associated with saline and silicone gel breast implants. A 2017 independent survey of 933 women found the following points:

  • 98% of women reported they would be somewhat concerned to constantly concerned about silent rupture with silicone gel implants, with 73% saying they would be very concerned or constantly concerned.
  • 89% of women said that they would be less likely to choose a silicone gel implant after learning that the FDA recommended regular MRI scans to check for silent rupture with silicone gel implants.
  • 89% of women reported that if the overall performance of the implant is similar, they would prefer an implant where rupture could be detected by looking at the breast.
  • 91% of women reported that if the overall performance of the implant is similar, they would prefer saline coming into contact with their tissue in case of rupture over silicone gel.

These survey results give insight into how women really feel about silicone gel breast implants and why an alternative is needed. Below we discuss these compromises in more detail, as well as how the IDEAL IMPLANT addresses these issues.

Natural Looking Results

In order to get natural looking breast implants you need an implant that doesn’t collapse, wrinkle, or ripple. Real breasts don’t do any of those things, and the goal of breast implants is to provide you with breasts that are as close to the real thing as possible. Saline implants are often cited as looking unnatural under the skin because the saline is not thick enough to provide stability to the implant.

This problem was addressed with the invention of silicone gel implants, which are filled with thick, sticky silicone gel. While silicone gel does a good job of giving women beautiful, natural looking results, they can’t offer the same peace of mind that saline breast implants do. The IDEAL IMPLANT breast implants are structured saline implants, which means even though they are filled with saline they moves similarly to silicone gel implants. Board-certified plastic surgeon Dr. Paul Loewenstein says the IDEAL IMPLANT, “has a very natural look and feel. The rippling that you sometimes see with the saline implants just hasn’t been an issue.” Dr. Hamas explains why the internal structure helps by saying, “in addition to providing support, the internal structure of the IDEAL IMPLANT controls movement of the saline, it behaves like a silicone gel implant.”

Peace of Mind

Saline breast implants and the IDEAL IMPLANT Structured Breast Implants can give women peace of mind because, unlike silicone gel, saline is naturally absorbed by the body if the implant ruptures. Additionally, a rupture can be detected by simply looking at the breasts. However, Dr. Hamas explains that the IDEAL IMPLANT differs from other saline filled implants because of the internal structure. He states, “it has a series of nested shells, three-to-five depending on the size, with two seperate lumens, or chambers. Because there are two chambers the implant won’t go flat if one chamber deflates so, unlike a saline implant, a replacement can be scheduled electively.”

A silicone gel implant requires an MRI to diagnose a rupture, a procedure that is expensive and not always accurate. In fact, New York City board-certified plastic surgeon, Dr. Sophie Bartsich explains, “I’ve found that sometimes MRIs are not actually very reliable. In some instances, a patient’s MRI said the silicone gel implant had ruptured, and then when I went in to operate on it, it actually hadn’t. I’ve had one or two patients where an MRI showed the implant wasn’t ruptured, but based on my clinical exam I really thought there was a concern, so I went in and it turned out it was ruptured.” From survey results and hearing from his own patients Dr. Hamas has realized “informed, health conscious women want to know what is going on inside their body.” Peace of mind is not possible if you are constantly worried about the status of your breast implants. Thanks to the IDEAL IMPLANT women can have beautiful, natural looking results with peace of mind.

What You Need to Know About Implant Rupture

You may be reading information about the compromises of breast implants and wondering, “how likely is it that my breast implants will rupture?” The answer depends on which breast implants you choose. Each FDA approved breast implant has undergone clinical trials, part of which measures the implant rupture rate. You can read the FDA reports and statistics here, or visit our Breast Implant Comparison page here to learn more about the specific rates of complications with certain breast implants. Dr. Hamas tells us, “most people do not know that the cumulative rupture rates of silicone gel implants over 10 years are very high: 9-24% in the MRI Cohorts for primary augmentation.” The seven-year FDA core clinical data for the IDEAL IMPLANT breast implants shows a rupture risk only of 1.8%. This number shows us that with the IDEAL IMPLANT you are much less likely to need a revision due to implant rupture. Dr. Larry Nichter, a board-certified plastic surgeon in Newport Beach, California says of the IDEAL IMPLANT, “it’s incredibly safe and so there’s far fewer lifetime surgeries with an IDEAL IMPLANT Structured Breast Implant, compared to traditional silicone-gel implants.”

Find a Surgeon Who Offers the IDEAL IMPLANT Today

After years of listening to patients, conducting research, and developing the IDEAL IMPLANT, Dr. Hamas explains, “The IDEAL IMPLANT is the alternative to silicone gel that women want. Natural feel, only saline inside for peace of mind, no silent ruptures, and no FDA recommended MRIs.” If you are ready to begin your breast augmentation journey you can start by finding a board-certified plastic surgeon who offers the IDEAL IMPLANT Structured Breast Implant. The IDEAL IMPLANT is only offered by board-certified plastic surgeons to ensure quality, safety, and the best possible outcome for your breast augmentation. Visit our surgeon finder page here to find one near you.

Breast Implant Surgery: Finding the Ideal Implants for You

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Picking the Ideal Implants For You

Before making an appointment with your plastic surgeon to discuss a breast augmentation, educate yourself on the three different types of implants, risks, complications, and what to expect during surgery. Picking breast implants is a decision that will have a lasting impact on your lifestyle and your confidence. Thoroughly researching breast implants before you see a surgeon will allow you to ask the right questions and make informed decisions which will lead to a better outcome physically, mentally, and emotionally. Visiting our Breast Implant Education Center is a great step to getting your breast implant surgery questions answered.

A Brief History of Breast Implants

Like many devices in the history of medicine, the road to developing the ideal implants for women has been rocky. Before modern-day implants, doctors were injecting women with a variety of materials including goat’s milk, ground rubber, and silk fabric. According to researchers Walter Peters and Victor Fornasier, paraffin injections and liquid silicone injections have been among the most popular choices from the 1890s up until modern implants began to be used in the 1960s. However, they caused many issues in unsuspecting patients ranging from painful lumps to death. Injections often traveled to other parts of the body such as the abdomen or armpits. One of the important facts to note in this history is the lack of regulation before the 1970s. In the US, Congress passed the Medical Device Amendment in 1976 which opened the door for regulators to ensure devices such as breast implants were tested and approved for safety before being placed on the market. To learn more about this history of breast implants read our post on the subject.

The Three Types of Modern Breast Implants

The breast implants you will encounter at your board-certified surgeon’s office are no longer injectables or hazardous substances but properly tested medical grade devices. Here is a brief overview of the three types of breast implants you should consider before your breast implant surgery.

    • Silicone Gel: the FDA approved silicone gel implants in 2006 after a lengthy testing and approval process. Silicone gel filled implants are comprised of a silicone shell filled with silicone gel. The gel inside is thick, sometimes giving these implants the nickname “gummy-bear” implants. Many women love the look and feel of these implants, and they have enjoyed popularity. However, a recent survey found that women do have concerns about the possibility of the implant rupturing without their knowledge, known as a “silent rupture.”  While the silicone gel implant is safe when intact, the FDA does recommend removing a ruptured silicone gel implant including the shell and any leaked silicone, so it does not become misshapen, cause discomfort, or migrate. However, the only way to detect a silent rupture is with an MRI, which is why the FDA also recommends women with silicone gel implants get an MRI at three years post-op, then every two years for the life of the implant.
    • Saline: saline breast implants have a silicone shell filled with sterilized salt water (saline).  These implants were the only implants approved by the FDA between 1992 and 2006. Women enjoy the peace of mind that comes with saline breast implants because the body naturally absorbs saline in the case of a rupture. There is no need for repeated MRIs as a rupture will be immediately evident, and nothing will migrate and need to be removed like silicone gel. However, because saline is less dense than breast tissue, these implants tend to look and feel unnatural and can cause ripples under the skin.
  • The IDEAL IMPLANT® Structured Breast Implant: the FDA approved the new technology found in the IDEAL IMPLANT after years of research, testing, and clinical trials. It was developed by a plastic surgeon to address the compromises women feel they have to make when choosing between saline implants and silicone gel implants for their breast implant surgery. The IDEAL IMPLANT is a saline filled implant with an outer silicone shell and a baffle structure inside that controls the flow of saline. The result is an implant that has structure and stability, fewer ripples, a natural look, a natural feel and peace of mind.

What Complications and Risks Should You Know About?

According to the FDA, the most common complications with breast augmentations are implant rupture, capsular contracture, reoperation, and removal. Reoperation and removal can occur due to a variety of reasons such as rupture or dissatisfaction with results. Removal may or may not be followed by replacement. It is important to note that breast augmentation is surgery and comes with the same risks and complications that occur with any other surgery. Your doctor can further explain risks and complications you should be aware of, including infection and problems with anesthesia. Different implant types and brands have their own statistics on the rate and risk of reoperation, removal, rupture, and capsular contracture. Choosing an implant with statistically lower risks means a decreased chance of complications that can lead to discomfort and removal. Read below for more information about implant rupture and capsular contracture, including important statistics.

Implant Rupture

An implant rupture is when the outer shell of an implant tears. With saline implants, this causes deflation as the saline flows out and is naturally absorbed by surrounding tissue. A rupture in a saline implant is immediately detectable because of total deflation. With the IDEAL IMPLANT® Structured Breast Implant, a rupture is still easily detectable, but the structured layers and two lumens inside mean the deflation will not be total. In silicone gel filled implants, the silicone gel may stay close to the tear or stick to the surrounding tissues. To remove ruptured implants the surgeon must remove the shell, and in the case of silicone gel implants, the surgeon must also remove any silicone gel stuck to the tissues. Removal surgery for silicone gel implants that have ruptured or had capsular contracture may include a capsulectomy, where the surgeon removes the thickened scar tissue surrounding the breast implant. To confirm a tear or hole in a silicone gel filled implant, your doctor will order an MRI. Some women with silicone gel implants may have had a tear or hole for several years without knowing it, which is why the FDA recommends regular MRIs for these women. The FDA recommends removal of all types of implants that have torn, even if the implant is not causing symptoms. See the table below for the rupture risk of some of the top silicone gel brands and the IDEAL IMPLANT® Structured Breast Implant.

Brand Name Rupture Risk for Primary Augmentation*
 

Allergan gel

Mentor gel

Sientra gel

IDEAL IMPLANT

7.4%

3.4%

5.4%

1.8%

*FDA Core clinical trial results for primary augmentation; 7-year for IDEAL IMPLANT and Allergan; 6-year for Mentor and Sientra since 7-year results not published.

Capsular Contracture

According to the FDA, capsular contracture is “the hardening of the breast area around the implant. It can occur in the tissue surrounding one or both implants. This hardening causes the tissue to tighten, which can be painful.” Capsular contracture can happen any time after your breast implant surgery. In many cases, your doctor will recommend removal and replacement. See the table below for the capsular contracture risk of some of the top silicone gel brands and the IDEAL IMPLANT® Structured Breast Implant.

Brand Name Capsular Contracture Risk for Primary Augmentation*
  

Allergan gel

Mentor gel

Sientra gel

IDEAL IMPLANT

16.2%

9.8%

10.0%

6.3%

*FDA Core clinical trial results for primary augmentation; 7-year for IDEAL IMPLANT and Allergan; 6-year for Mentor and Sientra since 7-year results not published.

To read more about implant types and common complications visit this post.

What Will Breast Implant Surgery Entail?

Before your surgery, gather information on what to expect before, during, and after the procedure. Knowing what will happen to your body will allow you to prepare mentally, physically, and emotionally, leading to a better outcome.

Before Surgery

Before your surgery, you will meet with a surgeon and choose the ideal implants for your body, desired results, and lifestyle. If you desire a natural look and natural feel, your doctor will most likely recommend the IDEAL IMPLANT® Structured Breast Implant, or a silicone gel filled implant. If you are concerned about the cost or hassle of repeated MRIs, or you feel uncomfortable with silicone gel, make sure your doctor offers the IDEAL IMPLANT so you can choose a saline-filled implant with a natural look and natural feel. Your surgeon should talk you through the procedure and answer any questions you have. If your surgeon ever makes you feel uncomfortable or refuses to answer important questions, consider looking for a new surgeon. For more information on finding the right surgeon read our post here.  

During Surgery

Breast implant surgery typically takes a few hours and, as long as there are no complications, you should be able to go home the same day. During the operation, you will be put under general anesthesia or IV sedation. Your surgeon will make one of the following incisions to place the breast implant:

    • Inframammary – under the breast fold
    • Transaxillary – under the arm
  • Periareolar – around the nipple

Silicone gel filled implants are pre-filled to a predetermined size. Saline implants are placed and then filled by the surgeon with the desired amount of saline. Because they are not pre-filled, the IDEAL IMPLANT, can fit through a smaller incision site. Your surgeon will place the implants either below the chest wall muscles (submuscular) or above them (subglandular). Your surgeon will then close the incision with tape, stitches, or glue.

Post-Op

Breast implant surgery typically does not require an overnight stay at the surgery center or hospital. Be sure you have a friend or family member available to bring you home, which should be an hour or so after surgery. Your breasts will be wrapped with gauze and a bandage or support bra. It is important to follow all your surgeon’s post-op instructions for the best possible outcome. Wear your support bra and rest for as long as your surgeon recommends, take any medication prescribed, and be aware of the signs of infection. Call your doctor immediately if you have any concerns, or visit the ER if you believe it is an emergency. After the first week, the worst of the pain should be gone, but swelling and soreness will remain for a few weeks. Following your surgeon’s instructions for limiting activities, exercising, and follow-up visits will ensure you end up with the ideal implants for years to come.

To learn more about what to expect from a breast augmentation visit this page.

How to Choose a Doctor

How do you know you’re choosing an experienced, compassionate surgeon who will help you through this process? Asking the right questions during your initial consultation will help you determine if a plastic surgeon is the right one for you. Your breast augmentation is a decision that will affect you physically, emotionally, and mentally for many years to come. Make sure you have a surgeon who listens to and responds to your questions and concerns. Keep in mind the following when interviewing a plastic surgeon.

    • Is your surgeon board-certified? Being certified by the American Board Of Plastic Surgery means your surgeon is kept to a higher standard of care and stays up to date with safe and effective methods of surgery. To learn more about the American Board Plastic Surgery visit their website.

For a checklist of questions, you should ask your surgeon, print this FDA Checklist.  

To find a board-certified surgeon in your area, visit the IDEAL IMPLANT plastic surgeon finder.

How Much Does Breast Implant Surgery Cost?

Breast implants vary based on the office you choose, the implant you choose, and your location. Because it is a cosmetic procedure insurance companies typically do not cover the surgery or any complications that may arise as a result of the operation. Despite this, many women feel like it is the best money they have spent because of the increased self-esteem they have. When calculating your costs don’t forget to add the following:

    • MRIs: if you choose a silicone gel implant the FDA recommends an MRI every two years to check for a “silent rupture”. Most insurance companies do not cover this procedure.
  • Rupture Risk, Capsular Contracture Risk: all breast implants are at risk of a rupture or causing capsular contracture, but some have a higher risk than others. Look at the statistics when choosing breast implants to make an educated decision. Don’t let your surgeon push you toward a specific implant if the risk factors make you concerned. Make sure you have money put aside in case you need a reoperation.

Your Life Beyond Breast Implant Surgery

Breast implants can give you more confidence and self-esteem, but getting them shouldn’t be a spur of the moment decision. When you educate yourself about the options, the risks, and what to expect you will be able to enjoy your new body for years to come. It all starts with picking the ideal implants for you. For more information about breast implants visit IDEAL IMPLANT today.

The History of Breast Enhancement Surgery

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Breast enhancement surgery has come a long way since women and their surgeons first started experimenting. According to research published in the Journal of Plastic Surgery by Walter Peters and Victor Fornasier, women have had anything from paraffin to silk fabric to glazier’s putty injected into their breasts.  However, the sometimes terrifying history of breast enhancement surgery taught doctors and researchers some important lessons and thankfully women can now receive safe and effective breast enhancements from board-certified surgeons.

Primitive Methods

The history of medicine is often filled with torturous procedures performed on patients who assume their doctor has their health and safety in mind, and breast augmentation is no different. As Peters and Fornasier discovered, injections were popular in many of the breast augmentations of the 19th and 20th centuries. Unfortunately for patients, the doctors experimenting with these materials, which included things like glass balls and epoxy resin, didn’t take the time to listen to patients or think through how the foreign objects might affect them. Peters and Fornasier say “As complications unfolded, physicians followed the pattern of first blaming the technique and the lay people doing the injections. Then, individual patient susceptibility, and finally the material itself, were blamed for the adverse effects that resulted. Poor outcomes made patients distrustful.”

Silicone Injections

Beginning in 1944 doctors started replacing the popular paraffin injections with liquid silicone injections. These silicone injections are not the same as the silicone-gel implants of today. Silicone gel implants used in today’s breast enhancement surgery are surrounded by a silicone shell to keep the gel in place. According to Peters and Fornasier, liquid silicone injections caused many of the same issues as paraffin injections: “migration of silicone to other parts of the body, inflammation, discoloration, and the formation of granulomas, ulceration and fistulae.” Despite its widespread use until the 1990s, liquid silicone has never been approved by the FDA to use as an injection for cosmetic purposes.

Silicone Gel Breast Implants

The first silicone gel breast implants were developed in 1962 by plastic surgeons Frank Gerow and Thomas Cronin. After the initial breast enhancement surgery trials, the implants went through a number of revisions. While these implants were certainly safer than their predecessors, the FDA still did not issue an approval and the implants dealt with numerous safety issues. By 1992 the FDA issued a voluntary moratorium on silicone gel breast implants while they reviewed the safety of the devices on the market. A few months later the FDA approved several Pre-Market Approval applications from major silicone gel breast implant manufacturers. In 2006, after extensive study of the safety of silicone-gel breast implants, the FDA finally approved the implants for women 22-years-old and older. If you visit a board-certified plastic surgeon today to discuss breast enhancement surgery, you will likely see these implants as they are some of the most popular options on the market. Despite the safety of these implants when intact (not ruptured), the FDA recommends women whose implants have ruptured get the implants and any silicone that has leaked into surrounding tissue removed, whether or not the patient is experiencing complications.

Saline Implants

Saline implants, which consist of a silicone shell filled with sterilized salt water, have been available for breast enhancement surgery since 1964. After the FDA pulled silicone-gel implants from the market in 1992, saline implants became the only safe option for women seeking breast augmentation. The FDA has approved their use in women aged 18-years and older. Saline-filled breast implants continue to be used, particularly by women who feel uncomfortable with silicone gel implants and the risk of a “silent rupture” (when an implant rupture is not apparent to the naked eye and an MRI is required to detect it, a concern only with silicone gel implants). The major drawback to saline-filled implants is the lack of viscosity. Because saline is closer to the viscosity of water than breast tissue, these implants have been known to ripple, buckle, or otherwise look unnatural. This is especially true if the recipient does not have much breast tissue or fat in between the skin and the implant. However, in case of a rupture, the saline is harmlessly absorbed by the body.

Is There a Better Option for Breast Enlargement Surgery?

When silicone gel breast implants were finally approved women had two options: the natural feel of silicone gel or the peace of mind of saline. While both silicone gel and saline implants are safe and approved by the FDA, a recent survey has found that women still worry about a “silent rupture” of silicone gel implants and what that could mean for their future. In fact, in the survey, which included over 900 female respondents, 98% of those surveyed said they would feel somewhat concerned to constantly concerned about the possibility of a silent rupture. Finally, after years of listening to patient’s concerns, dealing with unnatural looking saline implants, and ruptured silicone gel implants, Dr. Robert Hamas decided to develop another option.

The IDEAL IMPLANT: What is it?

Dr. Hamas, a plastic surgeon and the inventor of the IDEAL IMPLANT® Structured Breast Implant, decided to find a solution for women who want the natural look of silicone gel and the peace of mind of saline. In 2006 he founded Ideal Implant Incorporated and began the process of developing an implant to address what women want and need for their breast enlargement surgery. The IDEAL IMPLANT is a saline-filled implant with a silicone shell and multiple internal layers of baffle shells to control the amount of saline that flows throughout the implant. Because the saline is controlled more than single shell saline implants, the IDEAL IMPLANT is stable and does not ripple easily, giving it a natural, beautiful appearance. After ten years of development, refinement, and clinical trials, the FDA approved the IDEAL IMPLANT® Structured Breast Implant for women 18-years-old and older.

New Technology: Good or Bad?

Now in 2018 women have three options for their breast enlargement surgery: saline breast implants, silicone gel breast implants, and the IDEAL IMPLANT® Structured Breast Implant. But, given the rough history of breast augmentation, how can you be sure these implants are safe? New technology wasn’t always a good thing in the past, which is evidenced by looking at the variety of materials doctors used to insert and inject into their patients. Fortunately, the medical community has become more regulated and has more accountability, which results in more safety for consumers. Today, with research, FDA clinical trials, and years worth of data, we don’t have to be in the dark about new technologies like the IDEAL IMPLANT. Breast implant research and trials today are transparent and nothing like the experiments of the past. With the extensive data and FDA trial requirements, women today can have confidence in newer technology. You can even review the summary of safety and effectiveness data for the IDEAL IMPLANT® Structured Breast Implant from the FDA.

Where to find the IDEAL IMPLANT

The focus of IDEAL IMPLANT has always been addressing the safety and concerns of breast enlargement surgery patients. The majority of IDEAL IMPLANT is owned by plastic surgeons who shared Dr. Hamas’s concern for women and desire to offer more options. Because of this, IDEAL IMPLANT only partners with board-certified plastic surgeons. To find a surgeon near you use the surgeon finder feature on the IDEAL IMPLANT website.

Choosing breast implants is a big decision that will affect you for years to come. For more information about the IDEAL IMPLANT® Structured Breast Implant, visit the IDEAL IMPLANT website or make an appointment with a board-certified surgeon today.

History of Breast Implants

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Sometimes knowing where we have come from in the past helps us appreciate where we are today. The history of breast augmentation shows that breast implants have come a long way from their beginnings. A little background gives understanding to how revolutionary the IDEAL IMPLANT® Structured Breast Implant is for women today.

First Attempts with Augmentations

In 1890, Austrian doctor Dr. Robert Gersuny started the first breast augmentations by injecting his patients with paraffin wax. The results were not so pretty, as his patients experienced infections and lumps in their breasts. Then in 1895, Doctor Vincenz Czerny, also from Austria, experimented with the first implant idea by using a benign tumor from the back of his patient and placing it in the breast where another tumor in the woman had been removed! From this precarious start, through the turn of the century until the 1950’s, surgeons experimented with a variety of breast implant materials.  These materials included fat from the patient, glass balls, wool, sponges, ivory, even ox cartilage. Although proven safety was lacking, women still seemed willing to undergo pain, injection needles, and experiments to enlarge their bust size or fix asymmetrical breasts.

Breast Implants Change Everything

A new idea for breast implants came to a young doctor when he went to get a bag of blood from the hospital’s blood bank. Blood that had been stored in glass jars was now being held in plastic bags, and he noticed how it felt similar to the tissue of a woman’s breast. A team of doctors lead by Dr. Thomas Cronin developed the first silicone gel-filled breast implants in 1961, and the design of these implants stayed relatively unchanged over the next 30 years. However, in the 80’s, women became increasingly concerned about the safety of silicone gel-filled implants, so implants filled with saline began to grow in popularity, even though they had a less-natural feel.

The Best of Both Worlds

For decades, women wanting breast implants could choose saline filled implants that often rippled and felt unnatural, or they could choose silicone gel filled implants and worry about the risks of a silent rupture. Faced with this dilemma, a plastic surgeon designed breast implants that gave women the natural feel of silicone gel, yet with the safety of saline. The resulting IDEAL IMPLANT is the next level of technology offering women a structured saline filled implant that feels natural without the worry of silent rupture that occurs with silicone gel implants.

Find a board certified plastic surgeon in your area who can tell you more about breast augmentation cost, procedure, and implant choices. With the perfect breast implants, you can start to make your own history. Learn more today.