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.”

Which Is More Popular, Saline or Silicone Breast Implant?

Breast augmentation is either performed using saline- or silicone-filled breast implants, devices which not only increase the bust size but also regain the lost volume after childbirth.

In terms of popularity, silicone breast implants are almost outpacing the saline version.  This is not surprising because they provide a more natural result since they are filled with a cohesive gel that is designed to replicate the feel of breast tissue and fat.

The growing popularity of silicone breast implant can be attributed to the FDA’s decision to lift the ban in 2006 after several studies have suggested that there is no link between its use and cancer risk and systemic diseases.

Another reason why silicone implants are more popular than saline is that they are very ideal for women with little tissue and fat in their breasts.  And not surprising, a significant number of patients seeking breast augmentation have this anatomical feature.

On the other hand, saline implants can provide a natural appearance only if there is a moderate to significant amount of tissue and breast plastic surgeons can work with.

Meanwhile, a 2009 survey released by the American Society of Plastic surgeons revealed that 50 percent of breast augmentation patients had chosen silicone implants. 

Right after the lifting of the 16-year ban, silicone implant is gaining on saline version every year.  In 2007, 35 percent of breast implants used in surgery were silicone and they jumped by 47 percent a year after.

Difference Between Saline and Silicone Implants:

* Saline implants are filled with a sterile salt and water solution while the silicone version is filled with a cohesive silicone gel.

* Saline implants are prone to sloshing, which in turn results to higher risk of downward displacement than silicone with the same size.  For this reason, some doctors intentionally overfill the saline implants.

* Silicone implants need longer incision than the saline version, unless they come in a very small size.  By contrast, saline implants require a short surgical cut because they are placed empty inside the breast pocket before they are inflated with a sterile saltwater solution.

* Silicone implants can maintain their volume for years (except if there is a leak or implant failure) unlike the saline ones which have a natural deflation rate of 1 percent every year.

* For patients with a little amount of breast tissue, saline implants often result to unflattering, dome-shaped breasts while the silicone implants can provide a more natural result. 

However, saline and silicone implants provide almost the same aesthetic result for women with moderate to significant amount of breast tissue.

Effects of Saline Breast Implants Depend on the Amount of Tissue

As its name suggests, saline breast implant is filled with sterile saltwater; for this reason it provides a less favorable cosmetic outcome for women with little breast tissue and fat.  By contrast, patients with an ample amount of tissue will usually enjoy a more natural result because of the “thicker coverage.”

The reason why women with almost no breast tissue will have unnatural result with saline implants is that there is little coverage.  In fact, the implants will be easily felt through the skin, regardless if these are positioned under or over the muscle, particularly in the lateral side and bottom of the breasts.

And instead of having a teardrop-shaped breast, it would end up being unnaturally round.  So for women with little amount of tissue, silicone breast implants, which are filled with a cohesive gel that mimics the feel of glandular tissue and fat, are the best options for them. 

(However, using teardrop-shaped implants, which are always available in textured surface to prevent them from flipping over, are not advisable for women with a very small breast because of the higher risk of rippling.)

Another concern of using saline implants on women with limited breast tissue is the higher risk of rippling and wrinkling of the shell, which is caused by “lack of coverage.”  This problem may be even aggravated with the use of textured implants with large “graininess.”

On the other hand, patients with moderate to significant amount of glandular tissue—particularly those with firm breasts—will likely enjoy a more natural result with saline implants.  In fact, regardless of the type of implants they would use, it is easier for them to achieve a favorable cosmetic result.

But despite having more amounts of tissue and fat, women should still limit themselves from using large saline implants (filled with more than 500 cubic centimeter or cc) because it can lead to a higher risk of downward displacement than silicone implants with the same size.

Meanwhile, women with a modest amount of tissue will achieve a result somewhere in-between.  They will most likely feel the implant shell through their skin with saline implants, although the shape of their breasts will appear natural as if they have used the silicone version. 

In general, silicone breast implants are still the best option for these patients to achieve a more natural feel.  (When plastic surgeons mention the word “feel,” they are talking about the sensation of the breast as it is being touched by fingers.)

Thinking of Breast Augmentation Surgery?

Breast augmentation has been one of the most sought-after cosmetic procedures in 2010.  During this period alone, about 296,000 US patients had the surgery, with the number expected to grow in the next few years.

If you are thinking of having breast augmentation surgery, these are the most common questions of patients you may also have in mind:

·         Is the safety of breast implants monitored by the FDA?

Both saline and siliconebreast implants are considered safe both for breast augmentation and reconstruction following cancer surgery.  Currently, the FDA only allows Mentor and Allergan-Mentor to sell their products in the country.

·         What is the advantage of saline breast implants over the silicone version?

Saline implants require smaller incisions because they are only filled once they are inside the breast pocket.  Take note that no FDA-approved prefilled saline implants are sold in the US.  Another advantage is that you are no longer required to undergo regular MRI screening because there is no risk of “silent leak.”

·         Which is more popular nowadays, silicone or saline implants?

Most doctors believe that silicone implants are more popular these days because they can simulate the natural feel of tissue unlike the saline version which is typically described as like having a water-balloon inside the breast.

But because a leak may not have any manifestation (e.g., deflated-looking breasts), it is recommended that you undergo MRI screening at least every two years.

·         Is there any option other than saline and silicone implants?

A new breast implant called “gummy bear” implant is used in Europe, though it is not yet available in the US market, unless you will enroll in nationwide clinical trials to test the product’s effectiveness and safety.

Gummy bear implant uses the silicone gel that is more cohesive than the one used by the currently available silicone implant.

·         Do patients need revisions in the future?

Because breast implants are not guaranteed to last a lifetime, you will likely need revision breast augmentation at some point in your life.  This is because the devices are still subjected to the natural wear and tear which can lead to rupture and leak.

50 Years After Silicone Breast Implants Were Introduced

It was in the early 1960s when Thomas Cronin and his team have developed the world’s first silicone breast implants.  The idea started when they noticed that plastic bags used by the blood banks have the same softness of a breast.

When Cronin attended a plastic surgery meeting, one of his colleagues told him about a new company which had a new product that can be made into solid and liquid form, with a variety of viscosity.  Another great thing about the device was the extreme compatibility with the human tissue.

The medical-grade silicone can be turned into a solid form which will serve as the shell, while the cohesive silicone gel will act as the filling.  This material then paved way for the invention of silicone-filled breast implant, one of the most commonly used devices in cosmetic plastic surgery to date.

After creating the first prototype of silicone breast implant, the device was implanted into a dog.  The trial worked okay and so Cronin and his colleagues started to look for a woman who would be interested to have the first breast augmentation surgery through the new device.

The plastic surgeons found a willing test subject: Timmy Lindsey.  Now she is 80 years old and working in a care home in Texas.

At the time, no one would have ever imagined that breast augmentation surgery would become one of the most popular cosmetic surgeries worldwide.  In fact, a 2010 survey conducted by the American Society of Plastic Surgeons showed that 296,000 procedures were performed in the US.

It has been estimated that 5 to 10 million women worldwide had breast augmentation surgery for cosmetic reasons, although a significant number also had it to reconstruct their breasts after mastectomy (or cancer surgery), and for transsexual people to transition from male to female.

While breast augmentation is popular in the US and UK, this is not the case in some countries which have their own standard of beauty.  For example, the procedure is not as popular in Brazil because most people there prefer large buttocks rather than big breasts.

Today, most women who seek for cosmetic breast augmentation are categorized into two groups: those with small breasts who want to increase their bust size, and those mothers who have deflated-looking bosoms which are caused by childbirth.

In the US and most European countries, breast augmentation for cosmetic reasons can only be conducted for patients aged 18 years and older.

Bizarre Stories About Breast Implants

Just recently, a Florida woman made headlines after she was attacked by her ex-fiance’s new girlfriend.  While crime of passion is not uncommon, what makes the story bizarre is that she survived because her salinebreast implant prevented the pocket knife from piercing her heart and lungs.

If this story sounds weird, hold yourself from more bizarre news involving breast implants.

1.     Snake dies after biting a woman’s chest.

In 2011, a model from Israel was attempting a stupid act live on air: kiss a snake.  Unfortunately, the boa constrictor died after it bit her surgically-enhanced breast; reports showed the cause of death was silicone poisoning.

Surprisingly, the model did not suffer from any serious problem although she was rushed to the hospital right after the incident and was given an anti-tetanus shot.

2.     Politician raffles breast implants to raise funds for campaign.

In Venezuela, a politician raised money for his campaign by raffling off breast implants.  Gustavo Rojas defended his action and said that while people raffle televisions and other appliances, he decided to offer cosmetic surgery which he said was far more interesting.

“It is an interesting prize…I’m not showing disrespect to anyone,” Rojas said.  

3.     Woman survives gun attack because of her breast implants.

A Los Angeles woman was shot in the chest but survived when her breast implant stopped the bullet from reaching her heart.

When Lydia Carranza was brought to the hospital and underwent a CT scan, doctors were amazed to realize that the bullet fragments were millimeters away from reaching her heart and other vital organs.

Carranza was at her office when a co-worker’s husband fired at her and his wife.  The wife died during the shooting incident.

4.     Woman survives a car crash thanks to her breast implants.

A 24-year-old Bulgarian woman survived a head-on collision when her 40DD breast implants absorbed most of the impact, preventing fatal injuries on her ribcage, lungs, heart, and other vital organs.

While she survived the accident, her silicone breast implants did not.  A police officer said the devices worked like airbags—they absorbed the impact and protected the victim’s ribcage.

5.     Woman accused of faking breast cancer to get implants.

Trista Joy Lathern from Texas lied about having breast cancer to raise $10,000 which has been used to pay her breast augmentation surgery.  She even shaved her head to look like she was terminally ill.

When authorities found out her scam, she was charged with theft by deception.

Brazil Bans French-Made Breast Implants

Just recently, the American Society of Plastic Surgeons (ASPS) has released a statement saying the defective silicone breast implants made by PIP, a now bankrupt French company, did not reach the US.  This means that only patients who received breast augmentation outside the country are the ones who should only be concerned with the products.

But unfortunately, the ASPS said that about 80 percent of PIP breast implants were exported to other countries including UK, Chile, Spain, Germany, Colombia, Venezuela, Argentina, and Brazil.  For this reason, estimates suggest that 300,000 patients worldwide are affected by the substandard products.

Meanwhile, some reports show that PIP implants were sold by a Dutch-based company under the brand name “M” which was commonly used in Brazil.  And with the growing international scandal, the biggest country in Latin America has recently banned the defective products.

Aside from a nationwide ban, Brazil’s healthy ministry also said the government is willing to pay the medical costs for the removal of PIP breast implants.  This has also been the promise of French authority to the affected patients.

In fact, 39 women in Brazil have been entitled to receive implant removal surgery free of charge.

On the other hand, UK authority still insists that there is no reason to conduct a nationwide removal of PIP breast implants.  Such statement has appalled the public as some authorities directly said the government and clinics cannot foot the bill for about 40,000 patients with PIP implants, which are said to lack coating that prevents the gel filling from leaking out of the shell.

While Brazil is offering free implant removal surgery, the government said the coverage is only applicable for those with ruptured implants.  And without any symptoms, a patient should foot the bill if she is concerned with the potential complications associated with PIP’s products.

“We are not offering free preventive surgeries,” one government official said.

Currently, the health ministry has no idea on how many PIPbreast implants were imported and sold in Brazil.  However, it has discovered that in December last year alone, the country imported about 34,631 implants, with 24,534 of these were sold.

Substandard Breast Implants from France Did Not Reach the US—ASPS

About 30,000 women in France will receive surgery to remove the defective breast implants which are highly prone to rupture and leak, while approximately 50,000 patients in UK have these substandard devices which were manufactured by Poly Implant Prothese (PIP).

While the defective siliconebreast implants were exported to Brazil, UK, Chile, Argentina, Spain, Colombia, and Venezuela, the American Society of PlasticSurgeons (ASPS) said the products were never approved in the US.

In Germany and possibly elsewhere in Europe, the substandard PIP breast implants were sold under the brand name “M,” according to the ASPS website.  Meanwhile, about 80 percent of devices were exported outside France.

In a statement published on its web site, the ASPS said that “an American woman would need to have been implanted outside the United States in order to have received the implants that are now the subject of concern in France.”

According to earlier reports, about 50 clinics in UK have reported implant ruptures although the government said “there is no need to remove the products en masse.”

While the total number of British women with ruptured implants—which have been found to have a fragile shell—is still unknown, experts have estimated that about 1,000 patients could be affected.  However, this is just a conservative estimates assuming that implant failure rate is only 2 percent.

PIP’s cheap implants have been reported to be made of low-grade industrial silicone designed for mattress, making them “unfit for human use.”

Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said the “quality of the silicone in PIP implants is not of medical grade, therefore, these are not fit to be implanted into humans.”

While there is a call for the UK government to “require women with the substandard devices to undergo implant removal” and “to shoulder the surgical expenses,” the spokesman for private medical clinics said that it would be “irresponsible” to remove all the implants as clinics could not afford to pay all the related costs.

The spokesman added that their study has suggested that the rupture rate of PIP implants is “between 1 and 2 percent” which is described as “within the acceptable industry standard.”  However a separate study has shown that failure rate is approximately 7 percent.

PIP, which filed for bankruptcy two years ago, has been warned by US Food and Drug Administration in 2000 that its implants were substandard as the company failed to follow “good manufacturing practices.”