PIP Breast Implant Controversy

Hi everyone,

This is to enlighten the public and patients of CosmesisIndia, regarding the recent notice for recall and removal of PIP breast implants.

The following is the advisory issued by ISAPS regarding the same

Clients of CosmesisIndia can be rest assured that none of our implants were from PIP and there is no reason for an implant removal or exchange because of the recent developments.




Notice to ISAPS Members
8 January 2012
PIP Implant FAQs

To all ISAPS members: the following 10 Frequently Asked Questions (FAQs) have been developed to help our members respond to patients' questions about the PIP implant controversy. If you would like this document sent to you in another format so you can share it with your patients or post it on your website, contact the Executive Office at isaps@conmx.net We will upload it to the home page of the ISAPS website as soon as possible.
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International Society of Aesthetic Plastic Surgery
45 Lyme Road, Suite 304 - Hanover, New Hampshire 03755 USA
t / 1-603-643-2325 f / 1-603-643-1444
e / isaps@conmx.net w / www.isaps.org



ISAPS has two missions: ongoing education of our member surgeons and the safety of their patients. In the following Frequently Asked Questions (FAQs), our Board of Directors provides patients who have breast implants with information about the ongoing PIP/ROFIL breast implant controversy.



1. What is wrong with the affected PIP/ROFIL implants?
The French manufacturer Poly Implant Prostheses (PIP) and the Dutch company Rofil Medical used inferior, industrial 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.

2. Which implants are affected?
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.

3. How do I know what brand of implants I have?
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.

4. How high is the risk that the implant shell can rupture and for silicone to leak out?
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.

5. What happens when silicone leaks from an implant?
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.


6. Do I notice when an implant ruptures?
Probably not because 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.


7. What should I do if I have a PIP or Rofil implant?
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.

8. Will my health insurance cover the surgery costs to remove or replace the implants?
As an international society with members in 93 countries we cannot provide an exact answer to this question. We advise you to check with your plastic surgeon and your health insurance provider.


9. If I have my implants removed, is it possible to put new implants in at the same time?
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.


10. Do I need to look for a special surgeon?
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. The forty-one year old International Society of Aesthetic Plastic Surgery is the largest international society of individual board certified aesthetic plastic surgeons with more than 2,100 members in 93 countries. Surgeons undergo a strict application process to determine their qualifications to join the society. You will find a list of ISAPS members in your country on our website www.isaps.org


___________________________________________________________________________________
Dirk F. Richter, MD, PhD Joao C. Sampaio Goes, MD, PhD
Chair - Patient Safety Committee Chair - Communications Committee
Member, ISAPS Board of Directors ISAPS Past President
Wesseling, Germany São Paulo, Brazil
Email: dr.dirk.richter@t-online.de Email: clinica@sampaiogoes.com

Patient Speak -III ! " Breast Augmentation"

There isn't a single person in this world who can look into the mirror and go "Fantastic! I love the way I look! There isn't a thing I'd like to change".

We would all like to change one thing or another about our appearance. Say a smaller nose, bigger eyes, bigger breasts, flatter stomach and so the list goes on. However, not everyone is so troubled by their flawed appearance that they actually want to do something about it and change the way they look be it via simpler ways such as makeup and exercise or through slightly less common and more intimidating measures like cosmetic surgery.

Having undergone one such cosmetic procedure about six months ago, I guess I can say I was too troubled for comfort about a flaw I had perceived in my appearance....the size and shape of my breasts.

I have always been very conscious about my looks, I love to dress up and although one of the popular notions is that "Looks don't get you anywhere....they're superficial and not important....Beauty isn't skin-deep...blah....blah". I firmly believe that knowing she looks like a million bucks can do wonders to a woman's psyche, her confidence levels and self-esteem both in her personal as well as work life. The modern woman wants to look her best 24/7 and in today's world where everything has a price, if there's a way by which money can get you something that "god" and nature failed to gift you with, y not go ahead and get it? What's stopping anyone?

People say looks are insignificant...you're gonna get old...you are gonna loose your looks...they ain't gonna stay with you forever. But when you're young and looking good gives you a kick, if something as "insignificant" as a flaw in your appearance becomes a significant cause for your being unhappy and a safe solution is right under your nose, you would have to be of below average intelligence to ignore it.

In no way am I trying to justify letting your flawed looks bother you too much or going under the knife to change this and that, but I believe the bottom line is to live a happy life and if anything is a hindrance to that, but can be uprooted without hurting anyone, it should be done.

It was with a lot of apprehension that I went to meet Dr.Surindher for the very first time. I had never discussed my problem with anyone before and was anxious about several things such as letting someone see my flaws for real for the very first time, the pain involved in surgery, the cost of surgery, my family's reaction to this, etc.

However, Dr.Surindher was very professional and put me at ease very soon after I walked into his chamber. Before examining my breasts, he gave me an overview of the breast augmentation procedure explaining the different kinds of implants, the types of incisions, the expected results,the likely risks involved, common myths about the procedure, etc. I was fascinated by the amount of information he gave me. There was so much I hadn't known, although I had done some research myself about the procedure.I asked him a few questions about the surgery and what happens thereafter and got enlightening answers.

He then examined my breasts, made me try on some sample implants so that we could decide on the appropriate size for me. He also explained to me very clearly in what way the appearance of my breasts would change after implantation. One of the main problems with my breasts was that I had flatness on the upper side of my breasts as compared to the lower side where I was a little fuller. As a result, I've always had to wear slightly busty bra's to give me a fuller look. Dr.Surindher told me that implants would give me a good rise on the upper side of my breasts and also enhance the projection of my breasts to give me a fuller look. After a few trials, my asking some questions and stuff, we decided on a size and I was told I'd have to take up some routine tests before deciding to proceed with surgery. Dr.Surindher had also penned down details about the procedure so that I could review them and perhaps come back with more questions later.

Hence after a very satisfactory first visit, I made up my mind and decided to go ahead with the surgery. Just a few routine blood tests and I was back at the hospital where the physician declared me fit for surgery. Surprisingly, I was hardly nervous the morning I was to undergo surgery. I was thrilled actually 'coz I had never undergone surgery before and was curious about various things including anaesthesia. Once I was wheeled into the OT however, I was completely relaxed and the staff there were very cheerful and amicable and made it seem like I was there to have some fun.

Anaesthesia was hardly disturbing and when I came to after like I don't know how many hours, I was in hell. I don't know if it was just my extremely low threshold for pain or what but yes, I was hurting terribly. I was unable to move any part of my body. I was quite confused actually 'cos I had read women don't go through much pain and are up and about in like 48 hours after breast augmentation.

My breasts felt like lead and my back and arms were rendered immobile. It was sometime in the afternoon when I woke up from surgery and I knew I had to wait at least another couple of hours before I could see Dr.Surindher and ask him why I was in so much pain. I was given strong painkillers and sedatives for three days and while they did ease the pain a little, when the effects wore off after a few hours, I would get all impatient and desperate for relief once again. What bogged me down most was I was unable to leave my bed for almost four days after surgery despite Dr.Surindher constantly pushing me to get up, move my arms, take a walk, etc. I don't know if it was because this was my first surgical experience or due to my low tolerance for pain, I felt more agonized every time I was urged to move around. While I understood that constantly trying to move around would definitely ease the pain and make me more comfortable,it was simply too difficult.

I remember feeling like a school girl at one point of time when I started dreading Dr.Surindher's visits 'cause I knew he'd pull me up from bed and urge me to walk around and try moving my arms. He had begun to be more stern with me 'cause I was always refusing to leave my bed out of fear of pain. I think it was on the fourth day after surgery that I finally decided I couldn't do this alone and asked my mom to come over. She did and I don't know if it was the work of that magic wand all mothers have or what but I felt instantly better after she arrived and showed tremendous progress both physically and psychologically within 24 hours.

The next time Dr.Surindher came to visit me, he was very happy because I was up and walking around pretty effortlessly. I was immediately taken off the strong painkillers and was put on some mild tablets and antibiotics instead. On the fifth day,when I left the hospital,I hardly felt any pain,just a little tightness in my breasts. I had started wearing a supportive bra on the fourth day itself and that made me feel better.

Before I underwent surgery, Dr.Surindher had also explained to me what kind of bra's I should wear to ensure that my breasts are well supported. For a week after I was discharged, I stayed home, took some mild painkillers and antibiotics and kept myself as active as I could. By then I was pretty much able to indulge in my everyday activities and at the end of two weeks I felt well enough to travel by myself to visit Dr.Surindher again. This time, Dr.Surindher taught me how to massage my breasts regularly for the next 6 months and also gave me some creams to lighten the surgical scars under my breasts.

As for the way my breasts looked two weeks after surgery,the projection was certainly enhanced,my breasts were bigger and there was a good rise on the upper side of my breasts(not the flatness I had before) but since a pretty big implant had been fitted into me, my skin was all tented which gave my breasts more of a cone-shaped look rather than rounded fullness. However, Doctor told me that with regular massaging over the next 6 months the breasts will eventually fill up and take on a fuller look.

It has now been about 6 months since I underwent surgery and although I can't say I have been perfectly regular with my massages (twice everyday,mornings n evenings...it ain't easy :-) ), I have carefully followed Dr.Surindher's instructions and have been using the scar-lightening creams he gave me and have visited him for periodical examinations and the progress has been great. Like he said, within a couple of months after I began massaging, my breasts started losing their tented look and took on a rounder, fuller shape.The scars have become way lighter than they were before and will continue to fade over time is what I've been told.

The truth is I'm a much happier person today than I've ever been before. It has been a great relief to ditch the busty,uncomfortable bra's I used to wear before. The surgery and the entire process of healing and development had been a life-altering experience for me and the results were exhilarating. The way my body looks now has done wonders to my self-esteem and confidence levels and this has had a positive impact on both my professional and personal life.

Considering I had several apprehensions about undergoing the surgery and was in hell a lot of pain once i did, was it all worth the trouble??? Hell yeah!!

I'm sure Dr.Surindher can never really completely understand what a big difference this has made to my life. To me, this is the best decision I have ever made and if I had been able to do it sooner, I would have. I feel complete now and absolutely wonderful and one can't put a price on that!!

....................................................................................................................................

Dr.Surindher : - I would like to thank KS for this write up to help other patient's understand the procedure and be of help to other people who might be considering such an option.

The reason I asked her to write about it because this is the patient's point of view. I might write and explain a lot but, when it comes from the patient herself, then the whole experience is different.

She has been a wonderful patient and has been very patient even with my firmness at time understanding that it was for her own good. So as always, I once again take the opportunity to thank all my patients and for her article, especially KS.

Read more about breast augmentation on my blog http://cosmesisindia.blogspot.com/2007/02/mammamia.html

Mamma...mia.!!!!

Since times immemorial breasts have always held the fascination of mankind irrespective of the age. And the fact is just as true today as it was many years ago. But the only thing that has changed is the fact that women themselves also are starting to take notice of them. So let us examine and learn a few things about breast augmentation or as it is fondly called " A boob Job!"

Who undergoes a breast augmentation….?. Is it the celebrities or routine people?? What drives them to get the operation? Do they understand the risks involved and about the procedure???

For the first question the answer is no! It is not only the celebrities, but routine people, the housewife, the teacher, the software engineer, the doctor… people from all walks of life who undergo the procedure.

What drives them to get the procedure done?? Well a few have pathological problems in the chest area and hence have to go in for an augmentation. But, majority of the women undergo the procedure because either the volume was less to start off with or decreased with age and multiple pregnancies or sudden weight loss.

What drives them is the fact that breasts are a sign of femininity and these women feel that the decreased volume of the breasts affects the way they see themselves.

First of all let us understand some facts regarding breasts :
1. Breast size is variable in people and there is no fixed size which is the norm. Several deciding factors like the amount of breast tissue, heredity, how fat the person is and the fact that whether the person has been pregnant before all contribute to breast size. And of course age is a contributing factor as always

2.There is nothing like a perfect breasts.Usually perky breasts without a sag and nipples pointing forwards and a little laterally are acceptable as the norm but they vary with the size. Small perky breasts look good if the person is thin but not on a well built female. So its all about proportion.

3. 99.9% women have asymmetrical breasts the left usually being larger than the right. The nipples may be erect, flat, inverted, the areola may be large or small, with or without few hairs growing long, or the areola may be bumpy all of which are normal.

Regarding understanding the procedure and the risks involved, I’m sad to say that though most of the patients are educated women, hardly 10% of them really know about the procedure and the risks involved.

Broadly there are two categories of women undergoing the procedure. The first category or age group is the young women who are in their 20's who want to increase their bust size because they have underdeveloped breasts.

The second category or age group of patients are those in their 30's who are usually mother's who have finished with their families and now have their children off to school and have done with their responsibilities and want to get back into shape and feel they way they used to maybe 10 years and two children back. This section of patients has seen a steady increase and I'm sure we are going to see more of them. But in this group many a times they might require certain ancillary procedure along with a breast augmentation which is usually a breast lift or a areola reduction or the such.

Breast augmentation surgery was first performed in 1962 by a Texas plastic surgeon who used silicone breast implants to enhance the size of a woman’s breasts. 1997 HBO film "Breastmen" starring David Schwimmer and Chris Cooper shows a cinematic representation of the introduction of the concept of the breast implant to increase breast sizes and the early days of breast augmentation surgery and its pitfalls. Breast augmentation surgery has come a long way since then with lots of advancements in the type of implants and techniques, though the basic methods remain the same.

A common fear amongst women is the fear of cancer with implants. This is totally unfounded as per research done by various medical fraternities. Recently even in the US, the FDA has cleared the use of Silicone Gel implants. Otherwise, silicone gel implants are used widely all over Europe, South America, and Asia, though saline implants are also equally in vogue though more in North America..

Implants are commonly filled with saline or silicone gel. Both implant types have advantages and disadvantages. The saline implants are silicon bags into which saline is injected to fill it up. The advantage of this is that smaller incisions to place the implant can be used and the sizes can be increased or decreased in case of volumetric discrepancies between the right and the left breasts. But the disadvantage is that some of the saline may leak over a period of many years and the implant may have to be replaced.
The silicone gel implants are permanent as they do no deflate. But they require a larger incision size. They have a natural feel and the new highly cohesive gel implants do not leak even if they are punctured or cut. The choice of the implant is usually left to the patient.

The implant can be inserted in three ways either through the armpit or through a cut below the breast or through a cut around the nipple/areola. The approach is determined by the size of the implant and the individual patient. Recently the so called “Scar less Breast Augmentation” has been in demand also known as the “TUBA” Here a saline filled implant is inserted through the belly button and hence the scar is hidden giving it the name scar less.

The implant can either be placed in front of the muscle of the chest wall, “Sub glandular” or behind the muscle, “Sub muscular”. Placement of the breast implant under (behind) the pectoralis muscle is preferred in women with anatomically less breast tissue since the results are more aesthetic. Placement behind the muscle does not stop you from using those muscles, though body builders and weight lifters tend to prefer placement over the muscle.
Placement under the muscle allows for a more natural look and feel than placement over the muscle. Also, the incidence of capsular contracture is decreased with this placement. Placement behind the muscle allows easier breast self-examination and improved images with mammography when compared to placement in front of the muscle, all this because it is far away from the normal breast tissue.

The common problems after a breast augmentation surgery are mild pain and discomfort after the procedure. This is a little more in the sub muscular placement of the implant. Scar maybe a problem if you have an incision below the breast which will be seen in the initially but fades over a period of time. You might be required to do some regular massages for the next 6 months which your surgeon will explain after the surgery.

The most common cause of dissatisfaction amongst women undergoing the procedure worldwide has been the size of the implant with most women feeling that they should have gone in for a bigger implant. The cause for this is that initially because of the swelling the size looks more and as the swelling settles down the size feels a little smaller . But the size has to be determined by the amount of tissue she has, the incision , the type of implant.

In the end one has to realize that the final decisions are taken after a proper consultation and examination. Also the fact that, all surgeries have their associated risks and complications, which every surgeon operating on you will surely address.

This article was aimed at educating women about the procedure of breast augmentation, allay few fears and misconceptions and to help them make educated decisions regarding the same.

Dr.Surindher
www.cosmesisindia.com
#Note: This article is the sole property of cosmesisindia.com and Dr.Surindher. No part may be reproduced in complete or in part without permission from Dr.Surindher.