Gummy Bear Implants Seen to Create a New Trend

In March 2012, the US Food and Drug Administration has finally approved gummy bear breast implants (from implant manufacturer Sientra) after several years of clinical trials.  Meanwhile, the new devices have already been around for 10 years in Europe.

Compared to earlier versions of silicone implants, gummy bear implants have a more cohesive silicone gel that even if their shell is cut in half, the filling would not leak.  And with this characteristic, many plastic surgeons around the world believe that the new devices are probably safer than other types of breast implants.

Plastic surgeons coined the term “gummy bear” because the implants’ soft but firm structure is somewhat similar to the sweet candy.

Leading Los Angeles plastic surgeon Dr. Tarick Smaili believes the recently approved breast implants may further push the popularity of breast augmentation surgery in the country.  Last year, the procedure ranked first on the list of the most commonly performed cosmetic plastic surgeries.

In terms of advantages, Smaili said that gummy bear implants are “quite notable” particularly when it comes to safety.

“With the cohesive silicone gel, the possibility of rupture and leak is close to nothing.  Another advantage is that the implant is form-stable and would not lose its shape,” Smaili said.

And because the risk of leak is almost not a concern, regular MRI screening is no longer needed.  (This is a requirement for women with traditional silicone breast implants because their somewhat fluid gel would seep out in the event of rupture.)

Another advantage, Smaili said, is the lower risk of capsular contracture which happens when the surrounding scar tissue squeezes the implant shell to the point that it causes breast deformity, pain, and other complications.

The newest implant is also called “type 5 gel” because it is the fifth generation silicone implant in the market since 1962.  Meanwhile, silicone implants currently produced by Allergan and Mentor fall under the category of “type 4 gel” which is cohesive but not form-stable.

But because gummy bear implants are firmer than the earlier versions of silicone implant, they require a longer incision. Fortunately, patients can choose from four incision sites which are designed to make the scar less visible.

Another consideration is the risk of rotation.  Since the implants come in teardrop shape, they may result to deformity in case they rotate inside the breast pocket (though the textured or “grainy” surface can prevent this problem from happening).

Pricing for Breast Augmentation

Breast augmentation ranked first in the most commonly performed cosmetic plastic surgery last year, with about 307, 000 procedures conducted in the US, or an increase of 4 percent since 2010.

The price for breast augmentation varies, sometimes significantly because it is affected by the surgeon’s fee, location of the surgical center or hospital, and type of implant used during the surgery.  Meanwhile, patients should always bear in mind that the cost should not be the sole factor when choosing a doctor.

Nevertheless, the most expensive breast augmentation plastic surgeon does not necessarily mean that he is the best one to conduct the surgery.

If the surgery uses saline breast implants, the average cost is around $7,000—this already includes all the pre- and post-operative visits, anesthesiologist, surgical facilities, and body garments.  But if the procedure uses silicone implant, the price would be $800 to $1,000 higher.

Silicone is more expensive than saline implant because making it involves a higher manufacturing cost.  Another consideration to make is the plastic surgeon’s fee is usually higher if this implant type is used.

Patients should always bear in mind that the cost of cosmetic plastic surgery is higher in large cities than in most areas because the demand for such procedure is quite high.

People should always be cautious with extremely cheap or discounted plastic surgery because this is often a red flag; the surgery is most likely to be conducted by a non-specialist, or it may be an attempt to fill an empty O.R schedule—which should be a concern.  And in some cases, a very low price is just an advertising hype and may not be the inclusive cost of surgery.

Because breast augmentation and most cosmetic surgeries are quite expensive here, some patients are tempted to go abroad (in Thailand, the cost of breast implant surgery is said to be 50 to 70 percent less).  While there is nothing wrong with “medical tourism,” they should be extra careful since not all countries are as strict as the US.

Patients should always bear in mind that in case their surgery abroad leads to botched results, it may be difficult—or sometimes even impossible—to go after the doctor.  By contrast, the US is very strict when it comes to medical malpractice law; in fact, the records of doctors who have been sued or charged with a disciplinary action can be easily accessed via Internet, although some states require a letter of request before they disclose such information. 

Smaller Breast Implants—A Growing Trend These Days

In the 1990s, Pamela Anderson arguably popularized the “larger than life breasts” and was even flaunting them in Baywatch with her scanty, one-piece, red swimsuit.  But after two decades, the blonde beauty has downsized her breast implants in an effort to achieve a more natural look.

Plastic surgeons have noticed that smaller breast implants are the new trend these days.  In fact, many Hollywood stars have been reported to have “downsized” including Victoria Beckham, Drew Barrymore, Denise Richards, and Dolly Parton.  Also, Beyonce and Kate Hudson have been rumored to have had breast augmentations using small implants.

Take note that in the past, big-bosom celebrities were popular and frequently represented in the media.

In terms of aesthetic results, leading Los Angeles plastic surgeon Dr. Tarick Smaili believes that smaller implants look more natural especially when used by women with small frame.

“Smaller implants look very flattering on petite women simply because they add curve to the body without creating the heavy top look.  They also look natural that it would be hard to tell if someone has them,” Smaili said.

According to a recent survey, most breast augmentation patients today choose breast implants size between 200cc and 300cc because of the growing popularity of “natural look.”

However, women with a relatively large body-frame can also benefit from smaller or at least moderate-sized breast implants which can give a slimmer appearance.

Aside from giving a natural look, smaller breast implants also make it easy to do physical activities and exercise; in fact these are the popular choice of athletes and women with an active lifestyle.

Because of the risk associated with extremely large breast implants, US implant manufacturers Allergan and Mentor do not produce sizes that are over 800 cubic centimeter (cc), and while there are bigger saline implants, rarely these are used because of the potential problems they can cause.

In fact, no ethical board-certified plastic surgeon would use extremely large breast implants for cosmetic reasons as doing so can lead to a wide range of health problems such as chronic back pain, shoulder strain, bad posture, and difficulty in moving—symptoms that Sheyla Hershey, the woman who holds the world record for having the largest breast implants, are experiencing.

According to reports, Hershey, who is from Houston, Texas, has undergone several breast augmentations to achieve the 38KKK bust size.  But because no US doctors would dare to operate on her, she traveled abroad just to receive surgeries.    

Saline Breast Implants—Overfilling Vs Underfilling

Saline breast implants are filled with a sterile mixture of salt and water while their shell is made of solid silicone that is durable.  However, there is no guaranty that the device can last a lifetime because it is still subjected to the natural wear and tear; for this reason, there is always the possibility of needing a revision surgery at some point in a patient’s life.

One advantage of saline implants over silicone version is that in case of a leak, they will not lead to inflammation of the tissue although patients have to remember that the affected breast will appear deflated right after the rupture.  To correct this problem, the implant must be replaced with a new one during a revision breast augmentation.

However, saline implant has its shortfall; because of its watery consistency, it is prone to sloshing effect, which is attributed to the higher risk of downward displacement. 

One way to prevent the sloshing effect is to overfill the implants with a saline that is more than the amount recommended by the manufacturer.  Patients should remember that overfilling the implants does not lead to a bigger size but only firmer appearance.

For instance, implant manufacturer Mentor recommends its device to be filled with a maximum amount of 300 cubic centimeter or cc, but a plastic surgeon inflates it with 325cc.  Aside from making the implant firmer, the technique has also been said to reduce the sloshing effect.

Another probable advantage of overfilling saline implants is that the need for a revision breast augmentation can be postponed.  Because saline has a natural deflation rate of 1 percent every year, putting content more than the recommended amount of the manufacturer may help prolong the “viable volume” of the implant.

But one downside of overfilling saline implants is that it gives manufacturers the right to cancel the warranty of their products.  However, it does not mean that they will automatically void it, but the technique gives them that option.

While overfilling saline implant is a common practice, underfilling its shell is not since it can lead to a wide range of problems including higher risk of rippling and implant failure; this is because the constant “rubbing” of the folds can affect the integrity of the device.

Another common problem with underfilled saline implants is the visible ripple, which is more of a concern if the breast tissue and fat is limited.

Saline Breast Implants Info

Saline breast implants are used to increase the bust size or create more fullness especially in the cleavage and upper poles.  However, these devices are also used to reconstruct the breasts after mastectomy or cancer surgery in which the affected tissue or tumor is removed.

Saline implants vary in volume (defined by cubic centimeter or cc), shell thickness, shape (round vs teardrop), and shell surface (smooth vs textured).  They are also available in inflatable and prefilled version.

In the US, only the inflatable saline implants are available, meaning they are filled at the time of breast augmentation surgery.  With this design, plastic surgeons can insert the device using a very small incision, thereby minimizing the appearance of scars.

By contrast, prefilled saline and silicone gel implants require longer incisions.

As its name suggests, saline implant is filled with saline, which is a sterile mixture of salt and water.  And with its content, there is no serious risk in case of leak, although the tradeoff is that the affected breast will immediately look deflated and will need a revision surgery.

On the other hand, a leak in silicone implants that is undetected for a long period of time can lead to inflammation of the tissue, pain, and discomfort.  Because of such risks, patients with this implant type are required to undergo regular MRI breast screening at least every two years.

In the US, the typical size of saline implant ranges between 120cc and 850cc, although women who want to go larger will need custom-made implants.  But because of the risks associated with extreme sizes, most plastic surgeons would likely decline any surgery to patients who are “going overboard.”

All inflatable saline implants have valves, which are often located in front.  Most manufacturers use diaphragm valve; it has a “male portion” at the end of its tubing that when snapped into the “female receptor hole,” is left into the implant shell, thereby sealing the device. 

Meanwhile, women with limited tissue or small breasts are often advised to stay away from saline implant because it can lead to unnatural outcome (the bosom appears unusually round).  By contrast, patients with ample amounts of tissue have no problem with this implant; in fact, there is no visible difference if they use silicone or saline.

Because of the watery consistency, saline implants may lead to sloshing effect, thus increasing the risk of downward displacement.  To avoid this problem, many plastic surgeons intentionally overfill the shell with saline solution. 

Europe Seeks Tougher Breast Implant Test

With the controversies surrounding French-made PIP breast implants, the European Union is seeking tougher tests and inspections for these devices in an effort to protect consumers from substandard products.

Because of the slack system, some experts believe the implants manufactured by PIP have been sold in many parts of the world.  (But surprisingly, the devices did not reach the US after the FDA found the company’s failure to adhere in good manufacturing practices). 

Investigation shows that since 2000, PIP has developed a simple way to deceive third party auditors from discovering that it was using industrial grade silicone gel intended for making mattresses.  With this plan, the company was able to lower the manufacturing costs of its devices—of course at the expense of thousands of women who had the substandard implants.

According to estimates, about 400,000 PIP silicone breast implants were sold in UK, Spain, Australia, Brazil, Argentina, Colombia, and Chile.

To hide the industrial-grade silicone gel, PIP workers placed the barrels containing this substance in a separate warehouse while auditors were making a routine visit.  Meanwhile, one employee has admitted that he was asked to erase evidences from the computer system before the audits and add them again afterwards.

And as the company’s way to celebrate its fraudulent act, employees threw huge parties every time the auditors left the premise.

Going back to the EU regulators’ plan to overhaul the rules, the aim is to prevent medical device makers in charge of checking the safety of their own products, and to further beef up transparency. 

However, concrete plans to improve the oversight system are yet to be determined later this year.  But one possible solution is to carry out unannounced audits particularly when dealing with companies suspected of fraudulent acts.

In January 2012, PIP founder Jean-Claude Mas, 72, has been charged of involuntary injury two years after the French health ministry banned his company’s silicone breast implants which were sold in 65 countries.  The devices have been found to be prone to rupture because of their thin shell; in fact about 14 percent of women who have them removed suffered from leak.

Surprisingly, while Mas has admitted deceiving the French authorities for 13 years, he called the victims who filed complaints against him as those “who want to make money.”

The PIP founder has also criticized authorities for offering victims to pay for the removal of implants because it can put them to a “surgery risk.”

Myths Prevent Women with Breast Implants to Successfully Breastfeed

One of the most common misconceptions about breast implants is that they prevent women to successfully breastfeed their babies.  However, a study presented at the American Society of Plastic Surgeons showed that patients’ wrong belief is the main culprit rather than the devices themselves.

Mothers with breast implants who failed to breastfeed believed it can affect the appearance of their breasts.  However, pregnancy alone may cause some level of sagging because the ligament, skin, and tissue are stretched and may not be able to retract to their original position.

Women should bear in mind that the more pregnancies they experience, the more likely the appearance of their breasts is affected.  This simply means that even if a mother breastfeeds her baby or not, it does not make any difference in the appearance of her bust.

Dr. Norma Cruz, the lead author of the study, said that “breastfeeding won’t harm their [women] breasts, and it has significant health advantages for both mother and baby.”

The study involved 160 breast augmentation patients who were breastfeeding their babies.  Successful breastfeeding was defined by two weeks or more of exclusively providing natural milk.

The researchers have chosen women with almost similar demographics particularly in age, body mass, incision site during their breast augmentation surgery, and implant size; with this consideration, it is safe to surmise that their findings are quite accurate.

Among the 63 mothers who had successfully breastfed, only 13 percent believed it could adversely affect the appearance of their breasts.  By contrast, about 86 percent of the 97 women who were “unsuccessful” thought that it could result to negative impact on the aesthetic quality of their bust.

While Cruz understands that some breast augmentation patients were concerned with the appearance of their bust—after all, they have invested time and money for the surgery—she reiterated the importance of breastfeeding not just to babies but also to mothers.

“Evidence shows that although breasts sag more with each pregnancy, breastfeeding doesn’t seem to worsen these effects in women with or without breast implants,” she added.

While there is nothing wrong getting breast implants before pregnancy, leading Los Angeles plastic surgeon Dr. Tarick Smaili believes that women who are concerned with sagging may consider postponing the procedure.

“Pregnancy may have a slight effect on the appearance of the breasts, but not always to the extent that you will need revisions.  But if you are truly concerned about this, perhaps postponing the surgery is a good choice if you’re considering having babies in the future,” Smaili added.