PU Foam Implants PART 2

Miss Wilde · 10-27-2009, 12:01 AM

The rationale for foam covered implants

Why should the foam reduce contracture rates so much? This is revealed by histological analysis of the normal capsules associated with different implant surfaces. The collagen fibres which make up the capsule around both smooth and textured implants are aligned end on end. If a stimulus to contract occurs (whatever it may be), the fibres can shorten over one another concentrically around the implant causing a shrink wrap effect and the consequences with which we are all too familiar. PU foam implants work because the foam becomes integrated into the full thickness of the capsule. The foam is a 3D matrix or lattice and the collagen fibres wrap around the foam struts. They are no longer end on end but disjoined and cannot shorten over one another causing the concentric shrinkage. Thus contracture rates are literally decimated at least. A strong Velcro effect between the capsule and the implant invariably occurs. When removing these implants after some months there is a cleavage plane between the implant surface and the capsule. The explant is no longer covered in foam as this now resides in the capsule (Figure 1). This creates a stable marriage between the implant and the capsule. Rotation has not been described and the medium to long term downward displacement commonly seen to a greater or lesser extent with smooth and textured implants has also not been reported.

Figure 1 Comparison of unused foam implant surface and foam implant explanted after 6 month. Explantation cleaves the implant from the foam which is integrated into the capsule.
Textured implants, even when they do adhere, can only at best affect the capsule/implant interface as the texturing remains on the surface of the implant. This is insufficient to alter the full thickness of the capsular architecture and therefore to reduce contracture rates. The images below taken form Handel’s paper2 show the histologies of smooth, textured and foam capsules and should clarify the above.

Figure 2. Smooth surfaced implant capsule with collagen stained blue on the left and textured surface capsule with collagen stained pink on the right. Note the end on end alignment of collagen fibres.

Figure 3. Polyurethane foam covered implant capsule with collagen stained blue. Note interlacing and consequent disjoining of collagen fibres around the foam matrix which shows as the triangular structures as illustrated below in Figure 4 (from Sinclair10).

Safety

Are polyurethane foam covered implants safe? Unequivocally yes. They have been used in hundreds of thousands of women for up to 4 decades. The Handel 2006 data2,7 and Vazquez and Pellon’s 18 year experience3 show that other complications occur, at worst, at the same rate as for other implant surfaces. The temporary rash in 1% of patients is the only exception to this. Handel was using an older incarnation of foam implants from Surgitek, a division of Bristol Myers. Vazquez and Pellon were using Silimed implants which is what we have available today. Their results in a large number of patients closely followed for 15 years, all in front of the muscle, show a contracture rate of 1%. The attachment of the foam to the Surgitek implant surface was less reliable than Silimed’s vulcanisation process and this may explain why Vazquez and Pellon got even better results than Handel.

The foam does biodegrade very slowly over many years.10 Concerns arose when two case reports were published by Chan et al11,12 showing measurable levels of 2,4 TDA in the urine of two patients who had PU foam implants. Importantly it was not found in their blood. The Health Board of Canada commissioned research by an Expert Panel on the Safety of Polyurethane-covered Breast Implants.13 The panel could find no evidence of a significant risk but called for further investigation. This was done by Hester et al14 under FDA supervision. In summary, the reason no free 2,4 TDA was found in the patients’ blood was that it was never in the blood. Chan’s method of preparing the urine samples prior to detecting TDA is relevant. The urine was treated with 6 times normal hydrochloric acid and then boiled for 1 hour at 105o C. The elevated urinary TDA subsequently detected was present as an artefact caused by in vitro acid hydrolysis. This had cleaved 2,4 TDA off from the harmless oligomers that are produced as part of the slow metabolism of PU foam by inflammatory cell esterases. This has been the conclusion of other investigators as well.15

It is also important to realise that 2,4 TDA has never been shown to be carcinogenic in humans at any concentration and two occupational studies of workers exposed to it over long periods did not show any increase in cancers of any type.16,17

Also 2,4 TDA was detected intermittently in the urine of control subjects with no implants. Hester et al concluded the miniscule amounts of free 2,4 TDA found in the non hydrolysed urine of implanted patients posed no significant risk, a conclusion shared by the Health Board of Canada and Australia’s Therapeutic Goods Administration. Even if it was assumed that 2,4 TDA was equally carcinogenic in humans as it is in rodents, the levels found in the urine would equate to a lifetime risk of developing breast cancer increased by less than 1 in a million. A risk defined by the WHO as unmeasurable.

It is pertinent to compare this theoretical risk with the known real risk of death from a general anaesthetic given to a healthy patient undergoing a capsulectomy which she would not have needed it had she had foam implants – about 1 in 80,000. It should also be mentioned polyurethane foam itself has no association with an increased risk of cancer in any species and is used in other human prosthetic devices, such as pacemekers and prosthetic heart valves.

Disadvantages - myths and reality

In addition to the misperceptions concerning safety, other myths about these implants abound such as you can’t remove them once they are in, they are too difficult to put in or you need a bigger incision. These are simply not true and Silimed has been provided with operative videos by the author which prove this.
What are the real disadvantages? The temporary rash over the breasts occurs in about 1% of patients in the second post operative week and lasts for one to two weeks. It is itchy and the patient is well so it is easily diagnosed and distinguished from infection. It is treated symptomatically with anti histamines or topical steroids, has no long term effects and does not recur. Removal of foam implants, although much less likely than with other implants, is sometimes, but not always slightly more difficult than with non foam implants. It is however perfectly possible. If all of the prosthetic material needs to be removed then a capsulectomy will be required if the implants have been in for more than 3 weeks as the foam will have started to integrate into the capsule. In cases of infection this is not always necessary as removal of the prosthesis alone and appropriate antibiotic treatment is usually enough to allow successful re-implantation after 3 months. Late infection with atypical mycobacteria however would require total capsulectomy.

The learning curve for using these implants is not difficult as long as you know that these implants stay where they are put. They do not “settle” into the pocket. If they are too high the day after surgery they will remain so. Because smooth and textured implants often do “settle”, subconsciously we may tend to put them in slightly high to allow for this. When surgeons start using the foam if they are not made aware of this they may place the implants too high. However, if you know about it and sit the patient up before closing it should not be a problem. In fact I would argue that this is an advantage since it affords control and predictability of implant position to the surgeon.

Use in revisional procedures

The predictability of placement can be helpful when treating displacements and synmastia as the implant does not exert the same pressure post operatively on any areas of the pocket which may have been closed with sutures. Rotation of anatomical polyurethane foam covered implants has not been described in secondary cases.
If a patient has a grade 3 or 4 capsule then the gold standard treatment is the creation of a virgin tissue to implant interface and the use of polyurethane foam implants. This is either achieved by making a new pocket or a plane change depending on the specific circumstances of the patient. Such treatment will reduce her risk of recurrent contracture to 2% even though she has already had a contracture. If a capsulotomy only is performed and a new tissue to implant interface not created, the foam is unable to exert the same effect on the existing capsule and recurrence is increased to 50%.These figures come from Hester, Tebbetts and Maxwell.18 This paper was never published, I am informed, because they thought there was no point as foam is unavailable in the US.

Personal experience and conclusions

I have used these implants for more than 5 years in both primary and secondary patients. In the last 18 months I have used them in more than 500 patients and now use them exclusively. They are not a panacea but I have yet to see my first capsular contracture. I have had one unilateral downward displacement which occurred the day after the surgery presumably due to over dissection of the pocket on my part combined with suture breakage. I have not seen the insidious slight downward displacement over time which detracts from the final long term results with non foam implants. Other complications have occurred with the same incidence as with other implants. In short, my results have simply mirrored the results of surgeons overseas who have used these implants for longer than me. Whereas previously I was loathe to use anatomical implants unless they were really necessary because of the risk of rotation, now the majority of implants I use are anatomical. The ability to control three dimensions with an anatomical implant rather than only two with a round, allows me to get better results in many patients.

All elements of the operative plan are critical to optimising outcomes for breast augmentation patients. The choice of implant surface is one very important part of the plan which is entirely controllable and has predictable consequences. Handel’s finding that “Curves from Kaplan-Meier survival analyses reveal that contracture is a progressive phenomenon, and the longer any group of patients is followed, the greater the cumulative risk of developing contracture” is central to an understanding of the importance of this.

In Handel’s own words, “This contradicts the widely held belief that if patients remain contracture-free for a year or two they probably will not develop significant contracture.19 This finding may also have some relevance in understanding the cause of capsular contracture. If the risk of contracture persists for many years after implantation (as it appears to), it seems less likely that it is related to acute events such as bacterial contamination, surgical technique, drains, antibiotics, or other ancillary measures that have a short-term impact and more likely related to some chronic effect of implants on adjacent tissue.” 7

The evidence clearly shows you can modify this chronic effect and dramatically reduce the risk of the commonest complication and the commonest reason for reoperation by choosing one implant surface (with a 40 year proven safety record) over another. The evidence also suggests it is highly likely you can substantially reduce displacement, the second commonest complication and reason for reoperation as well. It is difficult therefore to justify not using such an implant or not telling patients about it. Certainly when patients are given the evidence to consider they virtually all choose foam.

If any one of us were a patient considering breast augmentation would we want to know about this option? How will you respond to the next contracture or bottomed out patient who asks you “why didn’t you tell me about the foam implants?”

In August 2009, Dr Leroy Young gave a presentation about polyurethane foam covered implants at the American Society of Plastic Surgeons annual breast meeting in Santa Fe. There were a number of surgeons present who had used the devices when they were available in the US and, unanimously, they said were the best implants they ever used.20

I have been fortunate to have given talks on these implants around the world. I always ask the audience if there any surgeons present who have used these implants for any length of time who have subsequently reverted to smooth or textured implants. I have not found one yet.

References

1. Ashley F.L. A new type of breast prosthesis; preliminary report. Plast. Reconstr. Surg 45:421-424 1970

2. Handel N. Long-term safety and efficacy of polyurethane foam-covered breast implants. Aesthetic Surg J 2006; 26: 265-274

3. Vázquez G. and Pellón A. Polyurethane-coasted silicone gel breast implants used for 18 years. Aesthetic Plast. Surg.31:4, p.330-6, 2007.

4. Handel N, Cordray T, Gutierrez J and Jensen J.A. A long-term study of outcomes, complications, and patient satisfaction with breast implants. Plast. Reconstr. Surg.117:3, discussion 768-70, Mar, 2006

5. http://www.allergan.com/assets/pdf/M..._Aug_Label.pdf p.34

6. Cunningham B, McCue J. Safety and effectiveness of Mentor’s MemoryGel implants at 6 years. Aesthetic Plast. Surg. On line May 2009

7. Handel N, Cordray T, Gutierrez J, Jensen JA. A long-term study of outcomes, complications, and patient satisfaction with breast implants. Plast. Reconstr. Surg. 117:3, 2006

8. Baeke J. Plast. Reconstr. Surg. 109:7 pp2555-64, 2002
9. Barnsley G P, Sigurdson, L J, Barnsley, S E. Textured surface breast mplants in the prevention of capsular contracture among breast augmentation patients: A meta-analysis of randomized controlled trials. Plast. Reconstr. Surg. 117:7 pp 2182-2190, 2007
10. Biodegradation of the polyurethane covering of breast implants. Sinclair T, Kerrigan C, Buntic R. Plast. Reconstr. Surg. 92:6, 1993

11. Chan, S. C., Birdsell, D. C., and Gradeen, C. Y. Detection of toluenediamines in the urine of a patient with polyurethane-covered breast implants. Clin. Chem. 37: 756, 1991.

12. Chan, S. C., Birdsell, D. C., and Gradeen, C. Y. Urinary excretion of free toluene diamines in a patient with polyurethane-covered breast implants. Clin. Chem. 37: 2143, 1991.

13. Expert Panel on the Safety of Polyurethane-covered Breast Implants. Can Med Assoc J 1991; 145 (9) 1125
14. Hester T.R. Ford N. F. et al. Measurement of 2,4-toluenediamine in urine and serum samples from women with Même or Replicon breast implants. Plast Reconstr. Surg. 100:5 pp1291-1298, 1997

15. Personal communication from Professor Paul Santerre, Department of Biomaterials, University of Toronto, 2008

16. Sorahan, T., and Pope, D. Mortality and cancer morbidity of production workers in the UK flexible polyurethane foam industry. Br. J. Indus. Med. 50: 528, 1993.

17. Hagmar, L., Welinder, H., and Mikoczy, Z. Cancer incidence and mortality in the Swedish polyurethane foam manufacturing industry. Br. J. Indus. Med. 50: 537, 1993.

18. Capsular contracture following augmentation mammoplasty: Long-term follow up of treatment with polyurethane-covered prostheses. Hester T.R., Maxwell G.P, and Tebbetts J.B. Unpublished.

19. Camirand, A., Doucet, J., and Harris, J. Breast augmentation: Compression. A very important factor in preventing capsular contracture. Plast. Reconstr. Surg. 104: 529, 1999.

20. Personal communication from Dr Leroy Young, Plastic Surgeon, St Louis. 2009

© Dr Daniel Fleming, September 2009

Email: daniel@breastimplantsaustralia.com
Web: www.breastimplantsaustralia.com

Disclosure

Dr Daniel Fleming receives compensation for consultancy services provided to Silimed from time to time.

jamsmak04 · 10-27-2009, 12:11 AM

I read this when looking into my implants. I loved the info. Alot of women, especially from canada and USA have misconceptions about the implants. I got mine in mexico and my new PS here in canada reused my implant, so if they were that bad then why would he put them in me. He actually listed 2 big benefits, they are not moving because of the texture so where you place them is where they stay, he said that symmastia pretty much is not a concern with these implants as they dont move and capsular contracture is pretty much a thing of the past with these.

10-27-2009, 12:01 AM	#1
Miss Wilde Join Date: Aug 2009 Location: Brisbane Queensland Posts: 8 Thanks: 0 Thanked 2 Times in 2 Posts	PU Foam Implants PART 2 The rationale for foam covered implants Why should the foam reduce contracture rates so much? This is revealed by histological analysis of the normal capsules associated with different implant surfaces. The collagen fibres which make up the capsule around both smooth and textured implants are aligned end on end. If a stimulus to contract occurs (whatever it may be), the fibres can shorten over one another concentrically around the implant causing a shrink wrap effect and the consequences with which we are all too familiar. PU foam implants work because the foam becomes integrated into the full thickness of the capsule. The foam is a 3D matrix or lattice and the collagen fibres wrap around the foam struts. They are no longer end on end but disjoined and cannot shorten over one another causing the concentric shrinkage. Thus contracture rates are literally decimated at least. A strong Velcro effect between the capsule and the implant invariably occurs. When removing these implants after some months there is a cleavage plane between the implant surface and the capsule. The explant is no longer covered in foam as this now resides in the capsule (Figure 1). This creates a stable marriage between the implant and the capsule. Rotation has not been described and the medium to long term downward displacement commonly seen to a greater or lesser extent with smooth and textured implants has also not been reported. Figure 1 Comparison of unused foam implant surface and foam implant explanted after 6 month. Explantation cleaves the implant from the foam which is integrated into the capsule. Textured implants, even when they do adhere, can only at best affect the capsule/implant interface as the texturing remains on the surface of the implant. This is insufficient to alter the full thickness of the capsular architecture and therefore to reduce contracture rates. The images below taken form Handel’s paper2 show the histologies of smooth, textured and foam capsules and should clarify the above. Figure 2. Smooth surfaced implant capsule with collagen stained blue on the left and textured surface capsule with collagen stained pink on the right. Note the end on end alignment of collagen fibres. Figure 3. Polyurethane foam covered implant capsule with collagen stained blue. Note interlacing and consequent disjoining of collagen fibres around the foam matrix which shows as the triangular structures as illustrated below in Figure 4 (from Sinclair10). Safety Are polyurethane foam covered implants safe? Unequivocally yes. They have been used in hundreds of thousands of women for up to 4 decades. The Handel 2006 data2,7 and Vazquez and Pellon’s 18 year experience3 show that other complications occur, at worst, at the same rate as for other implant surfaces. The temporary rash in 1% of patients is the only exception to this. Handel was using an older incarnation of foam implants from Surgitek, a division of Bristol Myers. Vazquez and Pellon were using Silimed implants which is what we have available today. Their results in a large number of patients closely followed for 15 years, all in front of the muscle, show a contracture rate of 1%. The attachment of the foam to the Surgitek implant surface was less reliable than Silimed’s vulcanisation process and this may explain why Vazquez and Pellon got even better results than Handel. The foam does biodegrade very slowly over many years.10 Concerns arose when two case reports were published by Chan et al11,12 showing measurable levels of 2,4 TDA in the urine of two patients who had PU foam implants. Importantly it was not found in their blood. The Health Board of Canada commissioned research by an Expert Panel on the Safety of Polyurethane-covered Breast Implants.13 The panel could find no evidence of a significant risk but called for further investigation. This was done by Hester et al14 under FDA supervision. In summary, the reason no free 2,4 TDA was found in the patients’ blood was that it was never in the blood. Chan’s method of preparing the urine samples prior to detecting TDA is relevant. The urine was treated with 6 times normal hydrochloric acid and then boiled for 1 hour at 105o C. The elevated urinary TDA subsequently detected was present as an artefact caused by in vitro acid hydrolysis. This had cleaved 2,4 TDA off from the harmless oligomers that are produced as part of the slow metabolism of PU foam by inflammatory cell esterases. This has been the conclusion of other investigators as well.15 It is also important to realise that 2,4 TDA has never been shown to be carcinogenic in humans at any concentration and two occupational studies of workers exposed to it over long periods did not show any increase in cancers of any type.16,17 Also 2,4 TDA was detected intermittently in the urine of control subjects with no implants. Hester et al concluded the miniscule amounts of free 2,4 TDA found in the non hydrolysed urine of implanted patients posed no significant risk, a conclusion shared by the Health Board of Canada and Australia’s Therapeutic Goods Administration. Even if it was assumed that 2,4 TDA was equally carcinogenic in humans as it is in rodents, the levels found in the urine would equate to a lifetime risk of developing breast cancer increased by less than 1 in a million. A risk defined by the WHO as unmeasurable. It is pertinent to compare this theoretical risk with the known real risk of death from a general anaesthetic given to a healthy patient undergoing a capsulectomy which she would not have needed it had she had foam implants – about 1 in 80,000. It should also be mentioned polyurethane foam itself has no association with an increased risk of cancer in any species and is used in other human prosthetic devices, such as pacemekers and prosthetic heart valves. Disadvantages - myths and reality In addition to the misperceptions concerning safety, other myths about these implants abound such as you can’t remove them once they are in, they are too difficult to put in or you need a bigger incision. These are simply not true and Silimed has been provided with operative videos by the author which prove this. What are the real disadvantages? The temporary rash over the breasts occurs in about 1% of patients in the second post operative week and lasts for one to two weeks. It is itchy and the patient is well so it is easily diagnosed and distinguished from infection. It is treated symptomatically with anti histamines or topical steroids, has no long term effects and does not recur. Removal of foam implants, although much less likely than with other implants, is sometimes, but not always slightly more difficult than with non foam implants. It is however perfectly possible. If all of the prosthetic material needs to be removed then a capsulectomy will be required if the implants have been in for more than 3 weeks as the foam will have started to integrate into the capsule. In cases of infection this is not always necessary as removal of the prosthesis alone and appropriate antibiotic treatment is usually enough to allow successful re-implantation after 3 months. Late infection with atypical mycobacteria however would require total capsulectomy. The learning curve for using these implants is not difficult as long as you know that these implants stay where they are put. They do not “settle” into the pocket. If they are too high the day after surgery they will remain so. Because smooth and textured implants often do “settle”, subconsciously we may tend to put them in slightly high to allow for this. When surgeons start using the foam if they are not made aware of this they may place the implants too high. However, if you know about it and sit the patient up before closing it should not be a problem. In fact I would argue that this is an advantage since it affords control and predictability of implant position to the surgeon. Use in revisional procedures The predictability of placement can be helpful when treating displacements and synmastia as the implant does not exert the same pressure post operatively on any areas of the pocket which may have been closed with sutures. Rotation of anatomical polyurethane foam covered implants has not been described in secondary cases. If a patient has a grade 3 or 4 capsule then the gold standard treatment is the creation of a virgin tissue to implant interface and the use of polyurethane foam implants. This is either achieved by making a new pocket or a plane change depending on the specific circumstances of the patient. Such treatment will reduce her risk of recurrent contracture to 2% even though she has already had a contracture. If a capsulotomy only is performed and a new tissue to implant interface not created, the foam is unable to exert the same effect on the existing capsule and recurrence is increased to 50%.These figures come from Hester, Tebbetts and Maxwell.18 This paper was never published, I am informed, because they thought there was no point as foam is unavailable in the US. Personal experience and conclusions I have used these implants for more than 5 years in both primary and secondary patients. In the last 18 months I have used them in more than 500 patients and now use them exclusively. They are not a panacea but I have yet to see my first capsular contracture. I have had one unilateral downward displacement which occurred the day after the surgery presumably due to over dissection of the pocket on my part combined with suture breakage. I have not seen the insidious slight downward displacement over time which detracts from the final long term results with non foam implants. Other complications have occurred with the same incidence as with other implants. In short, my results have simply mirrored the results of surgeons overseas who have used these implants for longer than me. Whereas previously I was loathe to use anatomical implants unless they were really necessary because of the risk of rotation, now the majority of implants I use are anatomical. The ability to control three dimensions with an anatomical implant rather than only two with a round, allows me to get better results in many patients. All elements of the operative plan are critical to optimising outcomes for breast augmentation patients. The choice of implant surface is one very important part of the plan which is entirely controllable and has predictable consequences. Handel’s finding that “Curves from Kaplan-Meier survival analyses reveal that contracture is a progressive phenomenon, and the longer any group of patients is followed, the greater the cumulative risk of developing contracture” is central to an understanding of the importance of this. In Handel’s own words, “This contradicts the widely held belief that if patients remain contracture-free for a year or two they probably will not develop significant contracture.19 This finding may also have some relevance in understanding the cause of capsular contracture. If the risk of contracture persists for many years after implantation (as it appears to), it seems less likely that it is related to acute events such as bacterial contamination, surgical technique, drains, antibiotics, or other ancillary measures that have a short-term impact and more likely related to some chronic effect of implants on adjacent tissue.” 7 The evidence clearly shows you can modify this chronic effect and dramatically reduce the risk of the commonest complication and the commonest reason for reoperation by choosing one implant surface (with a 40 year proven safety record) over another. The evidence also suggests it is highly likely you can substantially reduce displacement, the second commonest complication and reason for reoperation as well. It is difficult therefore to justify not using such an implant or not telling patients about it. Certainly when patients are given the evidence to consider they virtually all choose foam. If any one of us were a patient considering breast augmentation would we want to know about this option? How will you respond to the next contracture or bottomed out patient who asks you “why didn’t you tell me about the foam implants?” In August 2009, Dr Leroy Young gave a presentation about polyurethane foam covered implants at the American Society of Plastic Surgeons annual breast meeting in Santa Fe. There were a number of surgeons present who had used the devices when they were available in the US and, unanimously, they said were the best implants they ever used.20 I have been fortunate to have given talks on these implants around the world. I always ask the audience if there any surgeons present who have used these implants for any length of time who have subsequently reverted to smooth or textured implants. I have not found one yet. References 1. Ashley F.L. A new type of breast prosthesis; preliminary report. Plast. Reconstr. Surg 45:421-424 1970 2. Handel N. Long-term safety and efficacy of polyurethane foam-covered breast implants. Aesthetic Surg J 2006; 26: 265-274 3. Vázquez G. and Pellón A. Polyurethane-coasted silicone gel breast implants used for 18 years. Aesthetic Plast. Surg.31:4, p.330-6, 2007. 4. Handel N, Cordray T, Gutierrez J and Jensen J.A. A long-term study of outcomes, complications, and patient satisfaction with breast implants. Plast. Reconstr. Surg.117:3, discussion 768-70, Mar, 2006 5. http://www.allergan.com/assets/pdf/M..._Aug_Label.pdf p.34 6. Cunningham B, McCue J. Safety and effectiveness of Mentor’s MemoryGel implants at 6 years. Aesthetic Plast. Surg. On line May 2009 7. Handel N, Cordray T, Gutierrez J, Jensen JA. A long-term study of outcomes, complications, and patient satisfaction with breast implants. Plast. Reconstr. Surg. 117:3, 2006 8. Baeke J. Plast. Reconstr. Surg. 109:7 pp2555-64, 2002 9. Barnsley G P, Sigurdson, L J, Barnsley, S E. Textured surface breast mplants in the prevention of capsular contracture among breast augmentation patients: A meta-analysis of randomized controlled trials. Plast. Reconstr. Surg. 117:7 pp 2182-2190, 2007 10. Biodegradation of the polyurethane covering of breast implants. Sinclair T, Kerrigan C, Buntic R. Plast. Reconstr. Surg. 92:6, 1993 11. Chan, S. C., Birdsell, D. C., and Gradeen, C. Y. Detection of toluenediamines in the urine of a patient with polyurethane-covered breast implants. Clin. Chem. 37: 756, 1991. 12. Chan, S. C., Birdsell, D. C., and Gradeen, C. Y. Urinary excretion of free toluene diamines in a patient with polyurethane-covered breast implants. Clin. Chem. 37: 2143, 1991. 13. Expert Panel on the Safety of Polyurethane-covered Breast Implants. Can Med Assoc J 1991; 145 (9) 1125 14. Hester T.R. Ford N. F. et al. Measurement of 2,4-toluenediamine in urine and serum samples from women with Même or Replicon breast implants. Plast Reconstr. Surg. 100:5 pp1291-1298, 1997 15. Personal communication from Professor Paul Santerre, Department of Biomaterials, University of Toronto, 2008 16. Sorahan, T., and Pope, D. Mortality and cancer morbidity of production workers in the UK flexible polyurethane foam industry. Br. J. Indus. Med. 50: 528, 1993. 17. Hagmar, L., Welinder, H., and Mikoczy, Z. Cancer incidence and mortality in the Swedish polyurethane foam manufacturing industry. Br. J. Indus. Med. 50: 537, 1993. 18. Capsular contracture following augmentation mammoplasty: Long-term follow up of treatment with polyurethane-covered prostheses. Hester T.R., Maxwell G.P, and Tebbetts J.B. Unpublished. 19. Camirand, A., Doucet, J., and Harris, J. Breast augmentation: Compression. A very important factor in preventing capsular contracture. Plast. Reconstr. Surg. 104: 529, 1999. 20. Personal communication from Dr Leroy Young, Plastic Surgeon, St Louis. 2009 © Dr Daniel Fleming, September 2009 Email: daniel@breastimplantsaustralia.com Web: www.breastimplantsaustralia.com Disclosure Dr Daniel Fleming receives compensation for consultancy services provided to Silimed from time to time.

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10-27-2009, 12:11 AM	#2
jamsmak04 Join Date: May 2009 Posts: 1,297 Thanks: 312 Thanked 440 Times in 394 Posts	I read this when looking into my implants. I loved the info. Alot of women, especially from canada and USA have misconceptions about the implants. I got mine in mexico and my new PS here in canada reused my implant, so if they were that bad then why would he put them in me. He actually listed 2 big benefits, they are not moving because of the texture so where you place them is where they stay, he said that symmastia pretty much is not a concern with these implants as they dont move and capsular contracture is pretty much a thing of the past with these.