Some authorities have urged caution in the face of alarming headlines regarding possible cancer links with a certain type of Polyurethane-coated breast implants by Silimed (often termed “fuzzies” or “Brazilian implants”) have been banned from use and quarantined by some hospitals in the UK, as reported recently by the media. However, this appears to be just an overtly cautious approach during a review, which is not based on any new information, and therefore is no cause for alarm or anxiety in women who have had them inserted either in Australia or overseas.

A variety of Polyurethane-coated implants showed extraordinarily low incidence of capsular contractures. However, many of them had very thin shells and the polyurethane crystals disappeared leaving thin shells that ruptured or simply weren’t seen on re-operation. Polyurethane was later found to cause liver cancer in rats so the Food and Drug Administration (FDA) banned them from the US market in 1991. These implants were the precursors to the textured silicone implants since the “texturisation” was thought to be important in reducing the contracture of the capsule. Implant manufacturers couldn’t use polyurethane compounds anymore so they created the textured look on the silicone polymer (rubber) shell instead.

Polyurethane was a wonderful improvement with implants that stayed soft and natural, until of course the silicone rubber cover leaked, and then capsules began to form and the implant was in need of replacement. There are still two hurdles to overcome with polyurethane implants. The first thing is  that shear or stress on the cover can cause the polyurethane to separate from the surface (not what is intended) though the implant still performs well. The second issue is that as we removed and replaced the implants we found the polyurethane disappears over time. Where it goes and what effects it might cause will take many years of study to answer.

In summary, there is absolutely no new information about the Polyurethane-coated implants. As always, surgeons are advised to discuss the type of implants they use with their patient. If there are theoretical risks or disadvantages attached to any device, these should be discussed with the patient and the benefit of using the device must outweigh any possible risk or disadvantage. Patients should remain assured that there has never been a single case of cancer recorded in connection with these implants, and studies from the FDA show the theoretical risk to be one in a million over a patient’s whole lifetime.

Thanks for reading,

DrTim

We would like to preface the following remarks, by saying that patients treated at CosmeticCulture who have had breast augmentation with or without mastopexy or breast reconstruction, can be rest assured that we have never used the Poly Implant Prosthesis (PIP). Unfortunately, at the time of writing, the Therapeutic Goods Administration (TGA)  has been advised that approximately 9,054 PIP breast implants have been implanted by surgeons between 2002 and 2010.

1. PIP implants are defective

The French manufacturer Poly Implant Prostheses (PIP) and the Dutch company Rofil Medical used inferior, industrial grade (instead of medical grade), silicone in the breast implants they produced and sold. These products have a higher rupture rate than other available implants. Rupture can cause inflammation from silicone leaking out into surrounding tissue. Affected products are PIP breast implants that were used since 2001. These implants were also marketed under the name M-implant by the company Rofil Medical in the Netherlands and distributed in Germany by the company Rofil Medro. Affected Rofil implants are designated as IMGHC-TX, MX-IMGHC, and IMGHC-LS.  There is strong suspicion that PIP and ROFIL implants that were manufactured before 2001 are also affected and are prone to a higher rupture rate and therefore silicone leakage. Typically, patients receive an implant ID card after such an operation which gives information about the implant, the size and the batch number. The surgeon’s name and the date of implantation should also be recorded.  If you do not have such a card, we recommend that you contact the surgeon who performed the procedure to check his records and tell you. In Australia, non-implanted silicone implants manufactured by PIP were recalled by the Therapeutics Good Administration (TGA) in April 2010 and the Breast Implant Registry (BIR) was successfully used to contact both patients with PIP implants and those surgeons registered on the BIR who used PIP implants in their surgery.

2.  Potential for high risk of rupture and silicone leakage

Recent studies by the French authorities determined a risk or rupture of up to 11.1% for PIP implants. In conventional implants, the rupture rate is up to 2%. The durability of the PIP/Rofil implants appears to be much lower than normally accepted standards. This is in stark contrast to what TGA advises that, based on current rates of reporting of implant rupture to the TGA, there is no evidence of an increased rupture rate for PIP silicone gel breast implants used in Australia. The TGA has received 37 reports of rupture of PIP breast implants. This equates to a rate of 0.4% of PIP implants inserted in Australia over the past decade. This rate is well within the expected rupture rate for silicone breast implants. Long term follow up studies conducted in the USA show that rupture rates for silicone breast implants are approximately 1.0% per year. That means that for breast implants of all types approximately 10% of implants will have ruptured by 10 years after insertion.

Cracks in the outer shell of the implant can allow silicone to leak out and enter the body. First, the silicone passes through the lymphatic system into the lymph nodes in the armpit. From there it can move into the internal organs, which is rare. This industrial grade silicone can cause severe inflammation, irritation, and in some cases effusion. On the basis of previous studies, no increased risk of cancer was shown.

The TGA has tested PIP implants to determine the strength of the outer shell of the implant and its ability to resist rupture and determined that the PIP breast implants from the batches supplied and tested in Australia meet the relevant international standards for tensile strength. This differs from the results of testing of implants supplied in France by the French regulator AFSSAPS which showed lower tensile strength on one measure. This raises the possibility that the higher rates of rupture identified in France may relate to specific batches supplied in that country but not utilised in Australia. Importantly, the TGA and its British counterpart, the MHRA, have analysed the gel used in the PIP implants to assess whether it is toxic to cells (cytotoxicity) or likely to affect the DNA of cells (genotoxicity). This testing has demonstrated that the silicone gel utilised in the PIP implants supplied in Australia and the UK is not cytotoxic nor likely to raise the risk of cancer (genotoxic). The TGA has received no reports of the rare tumour Anaplastic Large Cell Lymphoma (ALCL) in Australian women who have received PIP implants.

3. A ruptured implant may go unnoticed

A crack in the implant shell can remain unnoticed, or it can lead to non-specific changes. Enlarged lymph nodes in the armpit should always be an alarm signal that leads the patient to consult with their doctor. After an accident or violent blow to the chest, you should see your doctor so he can decide if an ultrasound or magnetic resonance imaging (MRI) examination is appropriate.  These tests will offer clues to determine if there is a rupture or leakage, but often provide false negative results – meaning that no silicone leaks are seen.

4.  If you have a PIP or Rofil implant, see your surgeon

Definitely go promptly to the surgeon who operated on you for a consultation. The International Society of Aesthetic Plastic Surgeons (ISAPS) strongly supports the recommendation of the French authorities to remove the implants as a precaution, even if no symptoms or hints of rupture or leakage are present. Of course, you can decide after consulting with your doctor not to have surgery and to return instead for regular checkups.  If you decide not to have the implants removed, we recommend ultrasound or MRI scans twice each year to check for ruptures.

5.  You may need to remove or replace the implants

We advise that you to check with your plastic surgeon and your health insurance provider. If the implants are intact, it is always possible during the same procedure to replace them.  If, however, there are complications because of the state of the implant, it may be that insertion of new implants in the same operation is not possible if rupture has been undetected for a longer period and if the industrial silicone has caused an inflammatory reaction in the surrounding tissue. As the implant removal may be complicated, you should always look for a board certified plastic surgeon as he will have the experience to deal with unexpected problems.

Thanks for reading!

DrTim

The condition of a “funnel chest” (pectus excavatum) is relatively uncommon and presents its own unique problems for women requesting breast augmentation. The commonest question asked is, “Which pocket is best to place the implants?”

I have tended to place the implants under the muscle because the breast and skin can be very thin over the midline of the chest and can make the implants more visible with a higher chance of rippling.

I also inform my patients that the implants tend to slide towards the middle of the chest creating a very pronounced cleavage with nipples that tend to face inward (“cross-eyed” appearance). Because the patient with a funnel chest has a deeper midline, they will generate much more cleavage faster than one with a flat chest wall. In worse case scenarios, the implants can slide towards the midline and “kiss” creating the “figure-of-8” or “bread loaf” deformity. Consequently, the experienced plastic surgeon will use a slightly smaller implant and will go under the muscle and make sure to leave enough tissue intact along the midline to prevent the implants from coming too close.

As you can tell, this is a more difficult operation than regular augmentations. In my experience the implants tend to improve the appearance of the “funneling” in that the indented area of the chest wall is less noticeable.

Breast augmentation with implants will not necessarily raise the areola position in sagging breasts and in fact in some cases may make it larger. There are techniques to allow the implant to fall into the lower pole of the breast to create the illusion of lifting with more of the breast volume sitting lower on the chest. This is where using a tear drop or anatomical implants come to the fore.

The submuscular implants are “innocent bystanders” to whatever happens to the breasts, as they are really chest wall implants that simply push the breasts forward. The submuscular implants are supported by the overlying pectoralis major muscles. In contrast, implants above muscle (subglandular implant position) are more likely to fall with pregnancy or weight loss, as they are supported only by the overlying breast tissues.

A periareolar or circumvertical lift to reduce the areola size and raise the position on the breast is a reasonable choice. The lift is desirable because of the nipple position (usually at or below the breast fold) and breast laxity. Neither would be corrected with implants alone. “Blowing up the balloon” with large implants will create excessively large, still very droopy breasts. Reshaping the breast and elevating the nipple-areola complex and breast back up onto the chest will play an important role in helping one achieve an aesthetically pleasing result.

Most plastic surgeons have a clear policy defining the financial responsibility of the surgeon and the patient in case of complications involving breast lifts, both short and long term. The policy should be made clear to each patient before surgery. It may differ from surgeon to surgeon with the majority of surgeons not charging their fee for re-operating on the patient but the patient having to pay the facility and anaesthesia costs.

After considering breast augmentation, seeking and gathering information, choosing a surgeon, making a booking, having the consultation(s), then you’re ready for…

6) Surgery

Once you have decided on surgery, there are several more essential steps that need to be followed:

a) Day and time of surgery is scheduled
You and your surgeon have decided on proceeding with surgery, so you need now to sign the “Informed Consent Form” for the surgical procedure. Pre-authorisation for surgery may have to be obtained from your insurance company in special circumstances eg. breast asymmetry

b) Pre-registration phone call
A representative from the private hospital will call you up to a week in advance of your surgery. The purpose of this pre-registration phone call is to obtain necessary personal information such as your correct name, address, phone numbers and insurance information

c) Pre-surgery testing
Your health history may indicate the need for additional testing before surgery such as blood tests or imaging eg ultrasound or mammogram These are generally organised by your local doctor who will review your medical history, allergies and all medications and supplements you are taking.

Remember to call your surgeon’s office if you develop a cold, sore throat, fever or any other illness that occurs within 24 hours of your surgery.

d) Preparations before surgery
Fasting before your surgery means: no food or drink for at least 6 hours before your surgery. Do not bring any valuables to the hospital-remove rings, earrings and all jewellery. Bring a list of all your medications, allergies and supplements that you are taking so that they may be reviewed by your anaesthetist.

As a day-surgery patient you will most likely go home from the hospital the same day. If you receive a general anaesthetic or IV medication, by law you are required to have someone else drive you home. It is strongly suggested that you not drive the remainder of the day. It is advisable to have someone with you on your first day and night home from the hospital.

If you need to remain in the hospital overnight because of pain or nausea/light-headedness, you need only bring essentials like a robe, slippers, and toiletries. Leave them in your car and have a family member or friend bring them to your room later.

e) Instructions for day of surgery
You will have been given an assigned time to check into the private hospital. You will be escorted to the pre-operative area. Your nurse will ask and repeat very important questions in order to verify your health information, such as the type and location of your surgery, any allergies you may have, and when you last ate or drank. You may be asked these questions several times in order to confirm your information. This is required by the hospital by-laws in order to provide you with the highest quality of care.

You will meet with your anaesthetist and discuss the plans for your anaesthesia. Your intravenous (IV) line will be started and sedation administered. Your surgeon may stop by and this is a good time for any last minute concerns or questions you or your family/friends may have. This is the time that most surgeons tend to “mark out” their patients. This involves several markings on your chest with a water-proof marker outlining where the incisions will be made and the “foot-print” of the breasts. The latter markings allow the surgeon to determine the soft tissue pocket size in which to place the breast implants.

f) Going to surgery
When it is time for your surgery, an operating room nurse will complete a final pre-operative assessment. You will then be taken to the operating room (OR). Your family/friends may come with you to the OR doors. These people will be escorted by a nurse to the waiting room where the surgeon will be able to find them when your surgery is completed.

Following surgery, if you are staying overnight, you will be transported to your hospital room where your family/friends will be able to meet you. If you are an outpatient, your discharge instructions will be reviewed with your family/friends who are responsible for seeing you safely home.

Thanks for reading!

Dr Tim -  Sydney Cosmetic Plastic Surgeon

www.cosmeticculture.com.au

www.drtim.com.au

Patients need to understand that there is a process involved when entertaining the thought of having a breast augmentation (or indeed any surgery). There are a series of steps that you need to take to ensure the best possible outcome. These can be outlined as follows:

1) Considering

The physical triggers like saggy breasts, irregularly shaped breasts, breasts that are too small or stretch marks cause women to feel physically uncomfortable. They don’t feel sexy, attractive or feminine anymore, they have low self-esteem and confidence and to cap it off, they are limited in the choice of clothing they would like to wear. This is when women think “…maybe I should or maybe I could have breast enhancement.”

It all boils down to one thing: the desire for the woman to be “normal.” Obviously, normal means different things to different women. Some women want breasts that they had before they were breast feeding, whilst others, want breasts in proportion to the rest of their body. Other women prefer “womanly” breasts, natural breasts and breasts that don’t look like they have had them done. Lastly, there are those women who want more of a sexy breast or breasts like celebrities have.

The triggers that make a woman go “maybe I will have breast augmentation” are complex and varied. The most powerful trigger and barrier remover is knowing someone who has had breast enhancement. It makes the whole thing more real and possible because the results can be seen eg. the patient is happy and confident and her breasts don’t look fake or abnormal. Also, you can talk to the patient so that she can alleviate your fears about the surgery, the pain, the process and the outcome. She may even recommend the surgeon too.

2) Seek and gather information

This is the time when you are seeking reassurance “…am I making the right decision” or “am I choosing the right surgeon.” When you have a trusted referral, this step is more about checking information.

For others without a referral, this step can take up a lot of time. The good thing is, however, you can find most things online. Conduct your search with keywords such as breast enhancements or breast augmentation. Then get to a surgeon’s website specifically looking for a blurb about him/her, before and after photos, his/her overall approach and prices. Then if you’re happy with this information and feel comfortable, you may make contact or fill out enquiry forms or make an appointment. Some women may move onto blogs, photos, YouTube to get further “unbiased” information.

3) Choose a surgeon

The surgeon is often selected when the online information is credible and unbiased. Things to look out for are:

a)    “real” before and after photos, not models (in cosmetic magazines)

b)    information on the potential negatives as well as positives

c)    not overly “salesy” in approach or tone

d)    information verified by a third party

e)    surgeon comes across as professional and trustworthy

4) Make a booking

Usually this is done over the phone, occasionally one can make an appointment online or via email. Conversations generally are  relatively short and succinct eg. time and date or cost of consultation. Few women are asked to bring anything other than a list of their questions or a photograph of breasts they like. Bringing your partner or a friend as a “3^rd pair of eyes and ears” is also considered worthwhile.

At this point, there are 2 broad mindsets:

a)   “toe in the water”: they consider this a “reconnaissance” mission and are still very fearful or their motivations are not as strong.

b)    “getting it done”: they are highly motivated and often their fears are overcome. They consider this as if they have embarked on a journey.

5) Consultation/further consultations

At the consultation, the surgeon will usually go through 3 stages:

a)     your history, whether your have appropriate motivation(s) and whether you have realistic expectations or not

b)    the physical examination, taking care to point out any asymmetries in the breasts and chest, checking for breast lumps and noting relevant measurements to decide on implant size

c)     and lastly, whether you are suitable for surgery or not, and discuss your options at length. Time permitting, he/she may go through a trial of breast sizing and give you further brochures/information on breast enhancement/breast augmentation surgery

Most cosmetic patients are seen twice unless they have seen other plastic surgeons previously. The appointment is complimentary and usually discusses the risks/complications of surgery and anything else the patient doesn’t understand regarding the procedure. This may be supplemented further with before and after photos or talking to other patients having had the same procedure (ideally matched for segment age and life stage)

Free sessions with nurses, where the surgeon may join in for a few minutes may be helpful for women who are still undecided about making a booking because they’re anxious and fearful. This can be a helpful, reassuring step forward. This gives the woman an opportunity to ask any questions and get more information. The surgeon can conduct a brief examination and if the patient wishes, she can then book in for a paid consultation.

6) Surgery

This involves 6 steps in itself and will be discussed in “Are you ready for breast augmentation? Part 3”

Thanks for reading!

Dr Tim -  Sydney Cosmetic Plastic Surgeon

www.cosmeticculture.com.au

www.drtim.com.au

Women have been liberated in their minds for a long time now regarding breast augmentation: it no longer belongs in the realm of the rich and famous. It is now accessible to most women who concede that women, in the main, have breast enhancement surgery for themselves.

Most women grapple with 2 desires:

1)    Do I go natural or do I go for the more obvious look?

The vast majority of women that I see prefer their breast augmentation not to be obvious and for as few people to know about their procedure. “…I don’t want fake boobs. I just want the natural look and for no one to know.” In contrast, younger women generally have more of a desire to be sexy, and hence, prefer their breasts to be obvious. “I want them to look bigger like the girl’s breast’s in magazines.”

2)    Do my breasts need correction or do I need to create breasts? Most women after having kids undergo significant changes to their breasts, namely loss of volume, sagging and stretch marks. They have experienced what was “normal” and want it back. “…I felt I’ve lost my boobs and they were replaced with empty sacs. I want my 20-something perky, natural look back”. Whereas, there is a subgroup of women who have never experienced the breasts that they so desire, and feel robbed of the opportunity to feel womanly and curvy. They have insecurities about their breasts, “…I would always wear padded and push-up bras to increase the size of my breasts and create some cleavage. I always felt they were smaller than my friends and inadequate”.

Australian marketing research has shown that when the desires outlined above were analysed further, there were 3 clear segments that emerged:

1)    Establishers: “make me a woman”

Women in this category fit into all ages. They are determined not to look fake and are the most anxious. They often feel long-term envy about other women (especially friends who are well endowed), feel masculine or inadequate, often having to hide or mask their lack of breasts with padded bras or “chicken fillets.” They often don’t want other people to know about their intentions or the surgery.

Establishers tend to have been considering enhancement since puberty, often gathering information about breast augmentation for a long time. As a consequence, they may be relatively overwhelmed and confused with the many options available out there which may then breed fear and anxiety. These women need their anxieties alleviated and encouraged or reassured about a natural looking outcome following breast augmentation.

2) Restorers: “make me a woman again”

These are determined women and they don’t want to look fake. These women have lost their self-confidence, they feel like their mother or an older version of themselves and they know what it is like to have “normal” breasts. Their sagging breasts are often a result of breast-feeding or weight loss.

Restorers are clear about “wanting their breasts back” and should be encouraged or reassured about a natural looking outcome and restoration of “original” breasts.

3)    Boosters: “make me a lot more of a woman”

This group of women, usually 18-24 year-olds, are steadfastly determined and have a desire for the obvious look. Although they have similar reasons for considering breast augmentation to establishers, they feel pressured by the media/others to look a certain way eg. they want “celebrity” breasts. It is of interest that those that have had breast augmentation surgery, approximately 20% often want to have even bigger breasts.

In view of their determined mindset for the obvious look, most boosters are quick to make up their mind about breast implant size and shape, which pocket they want it placed in, which incision site they prefer and often book a date for surgery on the spot.

Now that you understand the 3 different categories of breast implant women, the next step is to go through the process of ensuring your best possible outcome when having a breast augmentation which is explained in “Are you ready for breast augmentation? Part 2″

Thanks for reading!

Dr Tim -  Sydney Cosmetic Plastic Surgeon

www.cosmeticculture.com.au

www.drtim.com.au