All about Breast Implants

NEWSFLASH


28 May 2018 - Article from the Australian Society of Aesthetic Plastic Surgeons

In response to the Sunday Telegraph's (27 May 2018) article by Sue Dunlevy it is important to clear some errors in the data and comments made.
Separating Facts from Fiction in relation to Cancer Risk from Breast Implants
https://aestheticplasticsurgeons.org.au/media/separating-facts-fiction-relation-cancer-risk-breast-implants
 

These comments by Associate Professor Mark Magnusson, President of the Australasian Society of Aesthetic Plastic Surgeons are all supported by data from peer reviewed publications, actually data that has been scrutinised by strict and blinded statistical analysis, the World Health Organisation (WHO) and from national regulatory agencies such as the Food and Drug Administration (FDA) in the United States and the Therapeutic Goods Administration (TGA) in Australia.


The facts

- Breast implant associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare form of Non-Hodgkins Lymphoma of the breast in women with breast implants. It is associated with textured breast implants, bacteria, time and there appear to be genetic factors as well putting some at greater risk.
- The risk of any lymphoma in an Australian women living to the age of 85 is 1:50.
- BIA-ALCL is a rare disease. Of 35 million women around the world with textured breast implants there are just over 500 confirmed cases and 16 documented deaths. The most accurate data at present shows that risk of this rare type of lymphoma varies from 1:2700 up to 1:80000 depending upon the type of textured surface. Smooth breast implants on their own have not been associated with this disease.
- There is also published evidence that suggests applying bacterial mitigation strategies at the time of surgery in the form of the 14-Point-Plan reduces the incidence of this disease.
- BIA-ALCL usually presents with a swelling of the affected breast or less frequently with a lump (or both) for no apparent reason from two to 14 years after the original implant surgery (average over seven years). However most delayed breast swelling after breast implants are not going to be BIA-ALCL.
- As with all cancers there are those who present in an early stage and those who present with more advanced disease. The disease has an indolent/slow course with most women diagnosed and treated in an early stage (>85%) with symptoms for eight months on average. At this stage the disease is cured with surgery alone without the need for chemotherapy, radiotherapy and with no recurrence when performed properly. To date, all patients with early stage disease who receive appropriate treatment are cured with surgery alone.
- In contrast, patients who present with more advanced stage disease (<15%) have had symptoms on average for 22 months (almost two years) before definitive treatment. If symptoms are not investigated and left untreated the likelihood of more advanced disease increases as with other cancers.

Assoc Prof Magnusson said with greater understanding of the disease and standardisation of treatment protocols patient outcomes are improving even further including for advanced disease.

There are inaccuracies in the published article by Sue Dunlevy.

It is stated that data published by Prof Anand Deva from Macquarie University and Assoc Prof Magnusson with others in a multidisciplinary task force has been challenged.

Since its publication the data has been acknowledged by the FDA in the US and the TGA in Australia as the best estimate of risk and incidence for BIA-ALCL in the literature to date. The data is supported by global BIA-ALCL research groups.

The TGA has received a full data set of the research which was independently verified by independent statistical analysis.

Although the Australia and New Zealand (ANZ) data was the first in the literature, there are similar studies now appearing in the peer reviewed literature from other countries that are confirming the ANZ figures in their own population.

There is no published analysis of the ANZ data in an academic peer reviewed forum questioning the original findings.

Assoc Prof Magnusson and Prof Deva have recently submitted an update of the ANZ experience for peer review and publication.

Dr Tansley is reported as indicating his group has performed detailed analysis of the ANZ data. His group have never had access to that data so there is no evidence to support his statement.

Reference is made to the report of two cases of BIA-ALCL with a suggestion that one resolved and the other regressed.

The validity of that paper has been questioned in the academic peer reviewed literature.

In one of the cases the original pathology was checked at an external laboratory (MD Anderson Cancer Centre in Houston, Texas) and found that the original diagnosis of no residual disease was in fact incorrect as cancer was still present. This wasn't reported in the final paper. The second pathologist had to write a report to the journal outlining the actual findings which have subsequently been published.
The accurate diagnosis of regression and resolution have very precise oncological criteria to avoid inaccurate comments. The paper does not meet these criteria which is pointed out in a second letter to the editor by Assoc Prof Magnusson and Prof Deva which has also been published after peer review.

By contrast most recent update to the ANZ data by Assoc Prof Magnusson and Prof Deva looks at 81 patients and shows that 85% of women are treated in the early stage and our data also demonstrates 60% have no residual disease at definitive surgery. This does not represent regression but reflects the indolent nature of this disease for most patients, which we already know.

The WHO outlined the diagnostic criteria for this disease in 2016.
At present there is no evidence that supports the diagnosis of two separate types of this disease as opposed to different stages of the same entity which presents at a more advanced stage when symptoms are present for longer duration's, just like other cancers.

It is a dangerous message to suggest that this disease will resolve on its own without definitive evidence as it may lead to patients refusing treatment because they believe it will spontaneously regress. What we do know from examining 500 worldwide patients is that even in an early stage, incomplete or inappropriate treatment of this disease has led to disease recurrence and even death. For a disease where death is such an uncommon event, it would be an absolute tragedy for this to occur because the illness wasn't treated properly on the basis of unsupported comments.

Scientific investigation is ongoing in several Australian Academic Institutions with Australian Plastic Surgeons and Haematologoists well represented among the world leaders for this disease. This includes the cause, risk factors, risk mitigation strategies and treatment protocols.
Patient safety and best outcomes must always remain the main focus regardless of what field of medicine we discuss.

 

2015 September - SUSPENSION OF SILIMED IMPLANT SUPPLY

TGA has issued a Safety Advisory notice with regards to Silimed implants due to recent concerns from the European Union health regulators. To read more about TGA's notice, please click here.

Silimed implants are not commonly used in our practice, and only in specific indications, such as recurrent capsular contracture or revisional surgery for previously inserted Silimed implants. If you are unsure as to whether you have Silimed implants, please check your postoperative pack which would have labels of your implants with the manufacturer and other details of the implants used during your surgery. If you are unsure, please call our office and we can check these details for you.

This Safety precaution is issued only for implants manufactured after March 2014, as Silimed passed the CE certification last year. The concern was only raised at their annual health regulator inspection this year. At this point, no further action is required or necessary for patients with Silimed implants, but if you do have a Silimed breast implant in situ, please contact your surgeon for an appointment to be updated with any new advice or notice from TGA. 

 

2014 RECALL OF Cereform Breast Implants - does it affect me?

There has been a recent product recall in France of Cereform breast implants.

THIS IS NOT A RECALL FOR THE CEREFORM BREAST IMPLANTS IN ANY OF OUR PATIENTS. The recall is for all breast implants manufactured after 10th February 2014, (and only implants that has not yet been put into patients). They have been recalled due to sterilisation standard issues.

If you are one of our patients who have had Cereform implants placed, you would have received a letter in the week of 23rd - 28th February 2014.

There has been no concern in regards to the integrity or the safety of the silicone implant itself.

The French regulatory authority has recently changed its standards on sterilisation of medical implantable devices. All manufacturers were required to adjust their facility and sterilisation process to meet the new standard. Unfortunately, Cereplas' (the company which manufactures Cereform) sterilisation certificate expired on 10th February 2014, before validation of their new processes could occur, thus their certificate to manufacture was suspended.

Currently there has been no evidence or reports suggesting any problem with the sterility of these implants.

At present, there is no recall for these implants in Australia. TGA (Therapeutic Goods Administration) in Australia has only suspended supply of Cereform implant until further investigation has been carried out. A decision will also be made in regards to whether any recall of these implants is actually necessary.

As mentioned, please be reassured that Cereform silicone implants are still considered to be high-quality safe breast implants. The issue under investigation here is the sterilisation process, not the actual implants. This is to ensure that no acute postoperative infection occurs after implantation.

At the time of your surgery, you would have been given a pack with your implant details, implant guarantee, postoperative instructions, and breast implant registry (BIR) form. If you have not filled out your BIR form and sent it in the envelope provided, please do so ASAP. If you are unsure as to whether you have sent in your form, please contact the Australian Society of Plastic Surgeons on (02) 94379200 to check for your registration. If you have lost the form, please contact our office for another one. Please do so even if you don't have Cereform implants. BIR is the central registry for breast implants, and is one of the few ways patients can be notified of any product recall if it occurs.

Statements have been released by both TGA and the Australian Society of Plastic Surgeons on Friday 21st February in regards to Cereform implants. We will of course keep you up to date with any further developments, and please also continue to check this page for the latest updates.

Please rest assured that we will continue to place your health as a priority and notify our relevant patients promptly if any actions need to be taken.

Please do not hesitate to contact our office on 3353 6165 if you have any concerns.

PIP Brand Silicone Gel Breast Implants

There has been reporting in the media about a French brand of breast implant manufactured by the company PIP (Poly Implant Prostheses). These implants have been found to contain industrial grade silicone gel which has not been approved for medical use. They were recalled following concerns by the French medical device regulatory authority (AFSSAPS) that there may be an increased incidence of ruptures and use of non-medical grade silicone with other unknown contaminants. They were withdrawn from the market in April 2010.
Based on current rates of reporting of implant rupture to Therapeutic Goods Administration (TGA), there is no evidence of an increased rupture rate for PIP silicone gel breast implants used in Australia. Tests conducted in Europe on the contents of PIP implants have also not shown any significant clinical toxicity. There is no indication at this point for PIP implants to be elective removed if there is no evidence of rupture.

To find out if you have PIP implants, see if you were given a card from your surgeon, containing information on the brand, size, and serial number of your implants. If you cannot locate the card, contact your surgeon or GP. If your breast implant surgery was performed by Dr Vrtik, your implants are not PIP implants. Dr Vrtik has never used PIP implants throughout her career.

If you are worried about implant rupture, see your surgeon or GP. An ultrasound may be recommended to exclude rupture. An MRI scan is much more sensitive and Medicare rebate has been approved for those with known PIP implants in place. Referrals for MRI's can be obtained from your GP or a specialist. This rebate is available for 12 months from 12th March 2012.

The latest Media Release from the Minister for Health The Hon Tanya Plibersek MP on March 10th, 2012:

"Medical advice from the Chief Medical Officer and expert committee is that removal of PIP breast implants in the absence of evidence of rupture is not routinely required.

"We want women to get the best clinical care including access to a subsidised MRI scan if they choose

"MRI is a key tool for the diagnosis of problem implants at a time when many women with PIP implants maybe fearful about the condition of their breast implants

"The patient's referring specialist or GP will need to identify in the referral that their patient is known or has a high probability of having a PIP-branded implant so they can be eligible for the Medicare rebate."

Resources:

To find out about TGA's latest advice on PIP implants, click here.

To find the latest television media release about PIP implants on ABC's Media Watch, click here, look for Episode 08, 26th March 2012

To find the latest update from Australian Society of Plastic Surgeons about PIP implants, click here.

 

About Our Practice  

Dr Vrtik uses Silicone Gel filled breast implants, except in very rare cases where saline implants are indicated. Silicone Gel implants has advanced to a very high safety standard (read below on safety of silicone), with a wide range of quality products on the market. Dr Vrtik chooses specific brands that have a consistent safety records and quality control measures. Silicone implants have many advantages over saline implants, including more natural breast appearance, feel and movement, as well as a greater range of products to suit the individual.

Breast Implants

Breast implants come in all shapes and sizes. Dr Vrtik will assist you in making the right choice of implant for your body type, shape and size. You will need to consider the following aspects of an implant:

  • Implant surface - smooth or textured
  • Implant shape - round or shaped
  • Implant profile - how far the implant protrudes (when viewed from side profile)
  • Implant size or volume - size typically ranges from 120 to 850 cc
  • Implant filler - saline or silicone

The breast implant you choose are based on the look you would like to achieve, as well as other individual and anatomical factors. For example, you may want to restore your pre-pregnancy or pre-breast feeding appearance, or increase the size of genetically smaller breasts. It is important that you discuss your goals and expectations with Dr Vrtik openly and honestly so that she may be able to assist in making the right choices.

Specific breast implants and tissue expanders are also used for women with severely asymmetrical breasts or to correct congenital deformities of the breast. Breast reconstruction for women who have lost their breasts to cancer also uses similar breast implants.

During your consultation with Dr Vrtik, options and recommendations will be made. Trialling with a sizer bra may also be performed to simulate the possible appearances of each implant size. It often helps for you to bring a tailored or tight-fitting shirt to your consultation.This will maximise your decision making in regards to which implant is right for you.

What is silicone?

Silicone is derived from silicon a natural element. This is combined with oxygen to form silicon dioxide or silica. This is the most common substance on earth, existing as beach sand, crystals and quartz. When silica is heated with carbon at a high temperature, silicon is produced. This is then further processed to form long chemical chains known as polymers which are also known as silicone. Silicone can be a liquid, a gel, or a rubbery semi-solid. Silicone is one of the most common products found in everyday use in polishes, suntan and hand lotions, antiperspirants, soaps, processed foods, chewing gum, waterproof coatings and even in natural foods such as cow's milk.

Are silicone implants safe?

Specific and extensive studies have been done in regards to the safety of silicone. The Institute of Medicine has concluded after many years of reviewing literature, reports and evidence, that:

There is no evidence that silicone implants are responsible for any major diseases of the whole body. Women are exposed to silicone constantly in their daily lives.

There is no evidence to show that breast implants cause general body muscle aches and joint pain. The incidence of auto-immune diseases is not higher in women with breast implants compared to that of general population. Similarly, there is no evidence associating breast implants with migraines, heart disease, or epilepsy.

Special studies have also determined that much higher blood levels of silicone have been found in cows' milk and commercially available infant formula than breast milk in women with implants.

Silicone (when escaped from a ruptured implant) can travel in the body. Most commonly it may form deposits in lymph nodes and liver. However, these deposits have not been found to be associated with any systemic diseases or organ dysfunction. Silicone deposits in the liver are also incidentally seen in patients on dialyss. Silicone has not been reported to deposit in any other organs in association with breast implants. Silicone does not have the ability to erode into tissues. When breast implants rupture, it does not erode through the ribs into the lungs.

Silicone is an inert material. Most of the reaction it incites is one from the body itself, walling it off from surrounding tissue - as seen when an implant ruptures, where the body forms a capsule (scars) around the seepage to contain and enclose it.

Is it possible to have an allergy to silicone?

It is a possibility for anyone to develop an allergy to almost any substance. Silicone allergies are however very rare. We are constantly exposed to silicone everyday in many household items. We also consume silicone in food such as milk and milk products.

Can I fly or scuba dive with implants?

It is recommended that you do not fly for at least two weeks after surgery and no scuba diving for at least 6 weeks after surgery. This is to allow healing of surgical site and for the implants to settle into position. This will also allow air bubbles around the implant to be reabsorbed prior to any significant pressure changes as seen in scuba diving.

In the long term, many women with breast implants fly and scuba dive safely. Slight contraction and expansion of the implant shell may occur with changes in pressure, and result in some air bubble formation. This could translate into 'gurgling' noises from your implants. These changes will spontaneously correct after 24 hours.

What is capsular contracture?

A natural reaction of the body to any device placed in the body is formation of scar tissue around the device creating a 'capsule' to isolate the device. This occurs with breast implants. Formation of a capsule is normal in anyone with breast implants. However, development of capsular contracture is not. Capsular contracture is when the capsule tightens and squeezes the implant resulting in hardening of the implant. This may progress to alteration of the shape of the breasts and unnatural appearance or movement of the breasts.

Capsular contracture is more common following infections, haematoma and seroma. It is also more common if the implants are placed above the muscle. There have been some studies which have shown increased risk of capsular contracture with smooth surface implants, but there was no difference in the incidence of capsule contracture between saline or silicone implants.

Capsular contracture may develop as soon as a few months after surgery to several years after surgery. Symptoms range from firmness and mild discomfort, to pain, breast distortion, hard palpable implants and/or displacement of the implants. There are different grades of capsular contracture, and the most common indications for treatment are pain, distortion of breast shape and displacement of the implants.
The treatment for capsular contracture is removal of the implants with its capsules. A choice is then presented as to whether the implants are to be replaced. If the implants were smooth surfaced and above the muscle, often the replacement implants will be textured and placed under the muscle to minimise recurrence of capsular contracture. Capsular contracture may still occur after repeated surgeries, this is often an indication of that particular body's strong reactions against any foreign device. Often, with recurrent and refractory capsular contracture, further replacement of implants may not be recommended.
After implant surgery, Dr Vrtik recommends patients to continually massage their breasts to soften the scar tissue and stretch the capsule around the implant. This should be performed at least 5-6 times a day in the first 6 months, then twice daily for the lifetime of the implants. This has been shown in some studies to prevent development of capsular contracture.

How often does breast implants rupture?

Breast implant rupture rate has markedly improved since the 1980's; from 20% to less than 1% today. The rate of implant rupture is accumulative (i.e. the risk accumulates over time). With present day implants, rupture rates are quoted to be from 0.4%-1% per year depending on the implant company. Dr Vrtik only uses implants from companies that have had substantiated safety records over a long-term period.

Implants made by most companies after the turn of the millennium also have an addition safety feature. The silicone gel within the envelope of the implant is cohesive. This means that the polymer chains are cross-linked, thus the gel, although soft, is not 'runny'. The gel retains its shape and cohesion to the implant even when the implant ruptures. Dispersion of gel is only likely if the implant has been subjected to significant impact.

What is the average life span of a breast implant?

Even though implants are not lifetime devices, they can last for a very long time if looked after appropriately. If you have breast implant surgery early in your life, they may need to be replaced sometime during your lifetime. This time period varies from woman to woman, some requiring replacement in a few years, some not for at least 20 years. There are several reasons as to why a woman may need an implant replaced, more commonly as a matter of choice rather than necessity. These include a size or style change, or due to complications such as rupture, capsular contracture or shifting of the implant.

If you are unsure as to whether your implants require replacement, you should contact your surgeon for a review. Dr Vrtik offers all her breast implant clients annual review consultations to check the integrity of the implants, as well as general breast examination.

How does smoking affect implant surgery?

Dr Vrtik will not perform any implant surgery in smokers. Total abstinence must be practice for at least six weeks before surgery and sustained for six weeks after surgery.

Smoking causes constriction of blood vessels, reducing blood supply and oxygenation of the surgical site. This results in decreased ability to heal, and an increase in the risk of infection. Implant infections are not minor events, often requiring prolonged hospitalisation and commonly, removal of the implants without replacement.

Am I too old for implants?

There is not ideal age for breast implant surgery. Cosmetic surgery with no medical indication is illegal in the State of Queensland under the age of 18. Breast implant surgery can be performed for girls under 18 if there is severe breast asymmetry (unequal in size), congenital deformities of the breast (e.g. tuberous breast deformity), or history of cancer resection in the breast. Dr Vrtik will assess your eligibility as part of your consultation.

There is no maximum age for breast implant surgery. General good health is the important factor, not age.
How will pregnancy and breast feeding affect my breast implants?

Every woman's body responds differently to pregnancy and breast feeding. Your breasts will enlarge the degree of enlargement varies from woman to woman; similarly, the degree of post pregnancy and breast feeding changes will depend on the amount of weight loss, your body's hormonal changes and its response. It is not uncommon that many women notice a gradual change in the shape of their breasts during this period, as seen also in women with no breast implants. The size of your breasts after pregnancy and breast feeding may change compared to pre-pregnancy period, due to hormonal effects and weight gain/loss which the size of your implant may also be a contributing factor. The size of the implants themselves does not alter.

Many women with breast implants have successfully breast fed their babies. Studies have shown that the level of silicone in not any higher the breast milk of women with silicone implants compared to those without breast implants. Certain incisions, such as the peri-areolar incision (around the nipple), may interfere with some woman's ability to breast feed, due to damage to the breast ducts during the insertion of the breast implant.

During breast feeding, some women experience mastitis inflammation of the breast and breast ducts. This may contribute to capsular contracture around the implant (see above). Prompt treatment with antibiotics when the symptoms first appear may minimise the potential to develop this problem. You should always report to your doctor with any signs of inflammation.

How will breast implants affect my mammograms?

Breast implants may interfere with finding breast cancer during mammography. It may also make mammography more difficult. It is very important that you tell your radiographer that you have an implant prior to your mammogram. Special displacement techniques and additional views may be used to maximise the sensitivity of your mammogram. Any personal or family history of breast cancer must be discussed with Dr Vrtik prior to any breast implant surgery.

There is always a risk of implant rupture with mammography. This risk is small and should not exclude you from having mammography. This is minimised if the implants are placed behind the muscle, and can be displaced as the breast is being compressed. Alternative screening for breast cancer apart from mammography is possible for women with breast implants, such as an ultrasound or an MRI, however, you must discuss your concerns with Dr Vrtik or your doctor so that the best option can be recommended.

Does breast implants cause cancer?

No studies have ever shown that breast implants cause breast cancer in humans. There is no evidence that silicone itself causes breast cancer.

There have been over 80 reported cases of Anaplastic Large Cell Lymphoma (ACLC) around the world in association with breast implants. This is a very rare form of blood cancer, and this particular type has not been shown to be an aggressive malignancy. With appropriate treatment, most cases have had clinical resolution. There has only been one death reported. In view of the number of breast implants that have been used world-wide, these cases are yet to be a cause for alarm. There has been no definitive evidence to explain how and why these cases have occurred or whether having breast implants truly increases one's risk of breast lymphoma, as it may be a coincidental observation only. There is no specific type or brand of implant, no particular institution, race or geographical location that indicates higher risks. Further studies are being conducted to find out whether this association is at any all related, or even significant. All clients on our implant registry will be kept updated and informed as necessary.

To find out more information about ACLC and breast implants from TGA, click here.

Is there a Breast Implant Registry (BIR)?

Dr Vrtik has a personal registry of all patients who have had breast implant surgery performed by her. This contains clinical records, as well as the date of surgery with all implant information. All patients on the registry will receive annual reminders for their yearly breast and implant examination. They will also receive any clinically significant developments or updates on breast implants pertinent to their care. Dr Vrtik's patients are encouraged to contact the office if they have any questions or concerns about their implants.

All patients who have had breast implant surgery before the 1st May 2015, (regardless whether it was cosmetic or reconstructive) with Dr Vrtik have been encouraged to join the Breast Implant Registry (BIR) at the Australian Society of Plastic Surgeons (ASPS). This is a voluntary registry and the registration forms were given to you after your surgery with the appropriate information filled in. It was your responsibility to sign, complete and send this form into ASAPS to become registered. Dr Vrtik could not register your implants on your behalf as your consent was required for any release of your personal and clinical data. Dr Vrtik is an avid advocate of the Registry, as she believes this is an important resource to keep all women with breast implants update and informed about their implants. 

The BIR at ASPS was created to provide a safe and secure database. It allowed patients to access and retrieve important information about their surgery and implants when required. It also ensured that the Registry could contact patients should there be any concerns regarding the breast implants they have received. The database is currently also used for research and educational purposes, where all information have been stripped of identifying data, and allows important advancements in the use of breast implants.

Unfortunately the BIR is now closed to new registrations. A new national registration program will be up and running via the Monash University in the near future. For those who are already on the BIR, please be assured that this registry is still active, despite the fact they are not accepting anymore new patients. You can access your implant details at anytime via the registry if required. To find out more about the Breast Implant Registry at Australian Society of Plastic Surgeons, click here.

Further information on:

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