Open letter to ANSM /Agence Nationale de Sécurité du Médicament, France) relating to the safety of textured breast implants

Open letter to ANSM /Agence Nationale de Sécurité du Médicament, France) relating to the safety of textured breast implants

Auditionpublique.prothesesmammaires@ansm.sante.fr

Personal background:

1, Dr. Per Hedén, am an Associate Professor in Plastic Surgery at Karolinska Institutet in Stockholm. Sweden and the Founder and Head of Akademikliniken, which is now Europé´s largest private hospital exclusively for plastic surgery. More than 5000 surgical procedures are performed at Akademikliniken every year. I have also published several book chapters in medical textbooks on the topic of breast augmentation and written close to 100 peer reviewed medical articles. I have also developed several new techniques applying to the use of breast implant devices and also held a large number of international workshops and lectures on this subject. I have also performed a large number of live surgery demonstrations of my techniques in many countries worldwide and I am a frequent presenter and moderator at medical congresses. I have also been hosting education events at Akademikliniken, where I have shared my knowledge on aesthetic breast surgery with a large number of plastic surgeons from numerous countries. I am also the organizer and president of the international plastic surgery conference “Beauty through Science” held each year in Stockholm. This conference is now the largest aesthetic medical conference in northern Europe. In 2018 it was attended by close to 1000 participants from 60 countries.

Statement on the safety of textured breast implants:

It is with great concern that I have read about the ANSM decision to recall textured Biocell@ and Microcell® implants and issuing a recommendation to preferably use smooth implants until decisions on the future use of textured implant will be made. This decision is likely to at least partly relate to the possible connection of textured implants to Breast Implant Associated Anaplastic Large Cell Lymphomas (BIA-ALCL).

It is sad to note that the ANSM decision appears to be made without taking the available and large amount of scientific date relating to ALCL into consideration. There is no doubt that patents must be informed about the possibility of a connection between textured implants and ALCL. It is also important that patients are informed and aware of the benefits of textured implants and that these devices are available to patients. After all there are many clear indications for these devices and considering the low risk for developing ALCL (likely to be somewhere between 1/2000 – 1/100.000 VS 1/9 women getting breast cancer) many women would chose these under certain situations. ALCL is also (if diagnosed early) usually an easily curable disease. The large majority of women with ALCL start by having a swollen breast. It appears that ALCL may be in the range of 1/3000 women (the New Zeeland Australia data) for the Biocell® implant surface. Considering the fact that Akademikliniken has performed around 30.000 of these we ought to have up to 10 cases since we started to use these implants 1995 but we have none. Thus it is also possible that other factors such as surgical technique and genetic predisposition play an important role in the development of ALCL. Anatomically shaped implant have many benefits and these implants must be textured to avoid rotational problems. Anatomically shaped implants are available in many more shaped than round ones as the height and width relation can be varied- naturally not possible with a round implant where the height and width are equal. This is of importance not only for the aesthetic patent but also and even more so far the breast cancer patient requiring a reconstruction. Considering the ANSM recommendation to predominantly use smooth implant it should be noted that smooth surfaces, if they do not have a capsular contracture have higher risk of malposition (bottoming out/lateralization) where the implant migrates lower or outwards from its initial position. It is also clearly documented in double blind studies that smooth implants placed on top of the breast muscle have a higher risk for capsular contracture (a hardening of the breast implant). These conditions may necessitate a reoperation with associated risks. The risk for unavoidable secondary operations must be compared to the risk for development of ALCL. With all of these aspects there is no doubt that prohibition of textured implants would be a bad decision.

In addition to all of the above it is important to underline that an ANSM decision to ban textured implants may cause unnecessary worries and concerns for many of the millions of women having these textured devices already implanted. TO remove implants in women who are symptom free and happy with the aesthetic outcome is to expose them to a higher risk than keeping these implants in place. What has been too little discussed is why there Is a clear need for textured implants and that there are obviously benefits of anatomical implants VS round ones, There are some poor publications claiming that there are no differences between round and anatomical, most well known Hidalgo´s paper in PRS. This must be opposed strongly and anatomical implants should be part of the experiences surgeons toolbox provided they are used in a correct way.

To simplify the comparison between round and anatomical implants is not good and to compare the outcome all of these considerations must be analysed:

Basic shape differences between a round and anatomical implants – and thus how it affects volume distribution and thus indirectly how it should be placed vertically in relation to the NAC 2. The height and width relation – and how it affects implant selection where low height implants come closer to the IMF and e.g. may limit the risk for double bubble but round obviously always has the same width height relation 3, The implant projection – the difference in appearance is smaller with low projection implants esp. selecting moderate height anatomical ones 4. The position in relation to the pectoralis major – muscle cover reduces the differences in upper slope shape 5. Amount of glandular cover – with a thick pinch cover at the upper border especially if implants have a moderate projection may have very similar appearance 6. The implants vertical position in relation to the NAC – high positioned anatomical implants may have a very pronounced upper pole bulge 7 Filling material and its elasticity and cohesivity. Highly elastic gel with less firm highly cohesive gel less upper pole bulge 8. Degree of implant filling – e.g. an underfilled saline implant much less upper pole bulge than an overfilled one 9. The degree of capsular activity – capsular contracture of an anatomical implant may create cranial displacement and rounded artificial appearance. 10. The observation angel. It may be very difficult to reveal differences between round an anatomical in the AP view but in oblique and side views it may be very apparent in the same patient.

Conclusion.

In conclusion and in relation to the above and all the scientific literature available on both textured implants and BIA-ALCL I would highly recommend that ANSM do not ban textured implants but rather recommend to only use these when indicated and when possible use a less aggressive texturing. Also issue an instruction for physicians to always informed patients about the possibility of ALCL after breast implant implantation and that texturistation may be connected to this disease and that patients always should examined with the diagnosis ALCL in mind should they develop a swollen breast or a lump

Sincerely

PER HEDÉN

ASSOCIATE PROFESSOR IN Plastic Surgery, MD. PhD,

Akademikliniken

Storängsvägen 10

SE- 115 42 STOCKHOLM-Sweden

Phone:

Office: + 46 8 614 54 00

Mobile: + 46 70 731 51 31

Personal phone consultations Wednesdays 08-09 + 46 8 614 54 24

Fax office: 0 46 8 614 54 20

Per. heden@ak.se