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.  

Breastfeeding with Implants 101

Many women with breast implants wonder if they can still breastfeed their babies or not.  Patients should always bear in mind that breast augmentation may somewhat affect the sensation of the nipple, although the devices do not automatically prevent mothers to produce natural milk.

Majority of women with breast implants are able to breastfeed successfully, despite some rumors that the devices can prevent them to do so.  There are also some misconceptions that these can contaminate the milk, potentially harming the baby; in fact, studies have suggested that formula milk contains significantly higher amounts of silicone than the milk produced by breast augmentation patients.

Meanwhile, small amounts of silicone are naturally present in mother’s milk.

According to a recent study, most breast augmentation patients who were unable to breastfeed were concerned that doing so may lead to sagging; this means the “inability to breastfeed” is really not the issue but more likely their “unwillingness.”

But contrary to popular belief, breastfeeding does not cause sagging as pregnancy alone is the culprit.  And the more pregnancies a patient will experience, the more likely her breast tissue and ligament will droop.

Breast implant itself does not cause compromised ability to breastfeed.  Most plastic surgeons believe that the incision site (e.g., within the breast crease, around the areola, and inside the armpit) is the factor that primarily affects the sensation of nipple after surgery.

For women who are considering breast augmentation but are planning to have a baby in the future, the best thing is to avoid the peri-areolar incision in which a U-shaped cut is made within the dark pigmented part of skin.  During the technique, there is a higher chance that the nerves are severed, thereby affecting the sensation.

Patients should remember that loss of sensation in the nipple makes it difficult to breastfeed.

However, several studies have suggested that years after breast augmentation surgery, most of the severed nerves can repair themselves, a process called reinnervation.  This clearly shows the remarkable ability of the body to heal itself.

For women with breast implants, they often have a better chance to successfully breastfeed if longer time has transpired since their surgery.  In fact, one study has suggested that five years after the procedure, most of the nerves that were damaged during the incision have already reconnected and have been repaired by the body.

Nevertheless, many doctors believe that inserting breastimplants on the side or underneath the breast will cause the least amount of damage to the nerve endings and milk ducts. 

Fat Grafting and Breast Augmentation

This year, it has been estimated that nearly half a million American women will undergo breastaugmentation either to improve their appearance or reconstruct their breasts following cancer surgery or mastectomy.

Breast augmentation is traditionally conducted by placing saline or silicone breast implants inside the “pocket.”  Meanwhile, these devices have been approved by the US Food and Drug Administration due to their “reasonable safety,” although patients should bear in mind that there is always a risk of rejection and other complications.

Fortunately, there is an alternative to breast implants.  Called fat grafting, the technique involves collecting fats from one donor site (e.g., abdomen and thighs) and then introducing them to another area of the body; and because no synthetic implant is used, patients should no longer be concerned with rejection and allergic reaction.

However, patients should always remember that fat grafting has its own limits.  For instance, the method is not applicable to those with limited amount of body fats; and it can only increase the breast one cup larger from its original size.

Another consideration to make is the result is somewhat unpredictable given the fact that some of the transferred fats will be reabsorbed by the body; and anything that remains a year after the procedure would likely be permanent.

One way to increase the survival rate of the fats is to purify them; this means the blood, connective tissue, and other impurities are removed.  With this method, about 60 to 80 percent of the transferred fats can survive in their new location.

But to further increase the survival rate of the fats, some doctors recommend using bra-like suction cones for three weeks prior to the procedure.  With this technique, they believe that the tension will create enough room for the grafted fats to flourish, although no extensive study can back up this claim.

After purifying the fats, they are carefully injected to the breasts; this process may take more than once to promote high survival rate of the fatty tissues.

Fat grafting that is used as a replacement for breast augmentation is like hitting two birds with one stone.  Not only the patients enjoy bigger and fuller bust, also the areas which have been liposuctioned such as abdomen and thighs will appear slimmer, resulting to a curvier body.

For three weeks, patients are usually required to wear a compression garment around the liposuctioned area; in this way, the skin will heal faster and closer to the body, thereby preventing sagging and improving the body’s contour.

Breast Enhancement Surgery

Nowadays, breast enhancement surgery comes in many forms including breast augmentation, mastopexy (raising the sagging bust), and reduction mammaplasty (decreasing its size).  And while each kind uses different techniques, their goal is the same: to improve the appearance of the bosom.

In 2011, breast augmentation was the most popular cosmetic surgery in the US, with about 307,000 procedures performed during the period.  Currently, the Food and Drug Administration has only approved saline and silicone breast implants for this surgery.

As its name suggests, breast augmentation is traditionally used to increase the bust, but with the introduction of new implant designs, it has become possible to use the procedure in creating a more prominent cleavage, and address certain types of breast deformity such as pigeon chest.

In some cases, breast implants are used to reconstruct the breasts after mastectomy or cancer surgery, although they can only be helpful if there is an ample amount of tissue left.  By using the devices, women can avoid unfavorable scarring associated with tissue-based breast reconstruction, and weakening of the donor site (e.g., buttocks, abdomen, back).

Another type of breast enhancement surgery is mastopexy in which the sagging breasts are raised to make them appear more appealing and youthful.  Contrary to popular belief, the procedure is not only popular among aging women but also on massive weight loss patients who often develop sagging, elongated breasts.

For some, mastopexy involves reducing the size of areola (pigmented part of skin surrounding the nipple) to complement the “perky” and youthful appearance of the breasts.  Doing this additional procedure does not necessarily mean more scars because doctors simply use the peri-areola incision.

While mastopexy can lift the sagging breasts, patients should take note that it cannot create volume especially in the upper and medial cleavage.  For this reason, many plastic surgeons suggest breast implants as a way to further enhance the appearance of the bosom, resulting to a prominent cleavage.

Brest reduction is another type of breast enhancement surgery, although women with medical problems caused by extremely large bust size will more likely see this as a reconstructive procedure.  If performed as a way to improve body function and address discomfort, insurance reimbursement is possible.

By contrast, breast reduction which is performed purely to enhance one’s appearance is not covered by insurance, as with any cosmetic surgeries.  In fact, most insurance companies require at least 300 grams of fats and tissue to be removed from each breast before the procedure is considered reconstructive. 

Are Sientra Breast Implants Better?

Just recently, the US Food and Drug Administration has approved a new brand of silicone breast implant; the device, which is made by California-based Sientra, can be used in breast reconstruction following cancer surgery, and cosmetic breast augmentation.

Dr. Tarick Smaili, one of the leading Los Angeles plastic surgeons, believes the FDA’s approval clearly shows the “reasonable safety of silicone breast implants, despite potential risks such as implant failure and hardening of the tissue or capsular contracture.”

“Any type of breast implant does not guaranty to last a lifetime, although modern designs can accommodate greater force and are quite resistant to the elements that are causing natural wear and tear,” Smaili said.

The plastic surgeon added that implant from Sientra is just like other brands already sold in the US market, thereby patients who will choose the new silicone implant are “technically choosing a technology that has been tried and tested for many years.”

“In fact, silicone breast implants have been subjected to the most rigorous, comprehensive clinical trials and surveys that would allow patients to make a good decision and understand the potential risks and limits of the devices,” he said.

Meanwhile, the plastic surgeon believes that Sientra breast implant is neither inferior nor superior to other brands manufactured by Mentor and Allergan, which used to be the only two companies allowed by the FDA to sell silicone and saline breast implants.

In 1992, silicone breast implants were banned in the US over concerns that they may increase the risk of cancer and many forms of systemic disease.  But in 2006, the FDA has lifted the moratorium based on facts that no study has proven the link between the devices and serious illnesses.

After the lifting of the 14-year ban, silicone breast implants are increasingly becoming more popular than saline implants because they provide a natural feel and look.  In addition, many doctors believe they are less likely to fail because the cohesive gel filling prevents wrinkling, a problem that can eventually lead to shell failure.

By contrast, saline implants—which are filled with a sterile mixture of salt and water—are relatively prone to “folds” that may rub each other, thereby increasing the risk of implant failure.

Over the past few years, breast augmentation via silicone and saline implants has been the most popular cosmetic surgery in the US.  In fact, about 307,180 procedures were conducted in 2011 alone. 

Botox for Faster Recovery After Breast Augmentation?

Breast augmentation surgery involves pain and discomfort during recovery.  However, plastic surgeons have come up with different techniques to shorten the healing time and reduce soreness and other postoperative symptoms.

One possible way to shorten the recovery is Botox injection; plastic surgeons use this treatment “off-label” to encourage the pec muscle to relax and allow the high-riding breast implants to settle downward quicker.

“Off-label” means using a treatment or drug beyond its real purpose.  For instance, Botox has been approved by the US Food and Drug Administration to remove certain types of facial wrinkles and address muscle spasm, although some doctors use it to encourage the implants to settle quicker into their natural position. 

After breast augmentation surgery, it is normal for the implants to appear unusually high off the chest wall.  This appearance generally lasts two months, although some women have to wait for as long as four months, as it takes time for the implants to drop and settle to a more natural place.

By relaxing the chest muscle, advocates of Botox believe the treatment can also speed up the recovery of patients.  And because the muscle is partially paralyzed, they also claim that there is less spasm and pain.

Crampy spasm following breast implants surgery commonly lasts several weeks or even months for some patients.

However, patients should realize that not all doctors recommend Botox injection to shorten the recovery after breast augmentation.  This is because other postoperative procedures have also been proven effective in minimizing pain and discomfort, and encouraging quicker healing.

For instance, some doctors recommend breast massage with compression exercise which can lead to faster recovery and encourage the implants to settle more naturally.  But when doing the procedure, patients should do this carefully and should avoid pinching the shell as it may affect the stability of the device.