I BRITISH JOURNAL OF ~ PLASTIC SURGERY [

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1 British Journal of Plastic Surgery (2000), 53, The British Association of Plastic Surgeons DOI: /bjps I BRITISH JOURNAL OF ~ PLASTIC SURGERY [ Patient satisfaction with Trilucent TM breast implants A. E Armstrong and B. M. Jones Department of Plastic and Reconstructive Surgery, The Wellington Hospital, London, UK SUMMARY We report our findings in a retrospective study of patient satisfaction with soyabean oil-filled mammary implants. Sixty-two women who had breast augmentation with Trilucent TM breast implants were sent a questionnaire to assess their satisfaction with implant placement; 19 of the 62 attended for clinical examination. Overall satisfaction with triglyceride implant placement was high: very pleased 45% (18/40), pleased 32.5% (13/40), content 12.5% (5/40). The majority of women felt that it had enhanced their body image and lifestyle (82.5%) The British Association of Plastic Surgeons Keywords: Breast augmentation, soyabean oil, Trilucent TM, outcome. Alloplastic breast augmentation continues to be one of the most commonly requested aesthetic surgical procedures. It is estimated that between and British women 1 have had breast augmentation, despite surgical and public concern at electively implanting prosthetic materials. Patient satisfaction with silicone gel-filled implants has been reported in the literature. 2 Radiolucent implants for mammographic screening became still more relevant when in 1992 the Food and Drug Administration in the USA banned the use of silicone gel-filled breast implants for cosmetic purposes, except in controlled clinical trials. In 1992 a soyabean oil-filled implant, Trilucenff M, (Lipomatrix Inc, Neuchatel, Switzerland) was developed and has been available for clinical use in Europe since We report the experience of a single operator, who since 1995 has used Trilucent TM breast implants. An assessment of patient satisfaction with these implants was performed as well as a clinical evaluation of breast capsular contracture and scarring. Methods The study was in two parts and was performed in an aesthetic practice in London, UK. A total of 62 women were identified and included 60 patients referred with bilateral mammary hypoplasia, one case of unilateral breast hypoplasia in a case of Poland's syndrome and one case of breast reconstruction following mastectomy, who requested exchange of silicone implants because of health concerns. The operations were performed by the senior author at The Wellington Hospital, London, between 1995 and The follow-up period was on average 14 months (range 6-24 months). All patients had subglandular placement of the implants, with the exception of six patients with non-ptotic breasts who had trans-axillary, submuscular placement. Five patients had exchange of Presented at the Winter Meeting of the British Association of Plastic Surgeons, 2--4 December 1998, The Royal College of Surgeons, London, UK. silicone for triglyceride implants: one due to unilateral implant rupture, three due to capsular contracture leading to firmness and one due to firmness and unsightly wrinkling of the breasts. The names of patients were retrieved from the medical notes. Patients were contacted by post to take part in the study and if no reply was forthcoming this was followed by a telephone enquiry. The questionnaire consisted of several parts and asked about the reasons for choosing a soyabean oil-filled implant, media awareness of silicone-related health co cerns, breast appearance, firmness, shape, nipple position, comfort, body image and, finally, lifestyle following implant placement. The second part of this study addressed the capsular contracture following placement of the implant and the postoperative scarring. In total, 19 of the 40 patients with completed questionnaires returned for evaluation of capsule formation. Patients were reimbursed for their travel expenses to the office by Lipomatrix Inc. The first author and a clinical nurse practitioner in plastic surgery independently assessed capsule formation using the Baker's classification (Table 1) and the postoperative scarring. Results Questionnaire A total of 62 women were identified from medical records following breast augmentation with a textured Table 1 Baker's classification Grade I II (minimal) I[I (moderate) IV (severe) Features on palpation of the augmented breast Feels as an unoperated breast (absolutely natural) Less soft, the implant can be palpated but is not visible More firm, the implant can be easily palpated and it (or the distortion from it) can be seen Hard, tender, painful and cold. Distortion is often marked 479

2 480 British Joumal of Plastic Surgery Trilucent TM soyabean oil-filled implant and were sent questionnaires. There were 22 non-responders (35%) and overall 65% (40/62) of those approached returned the questionnaire. Some questions were answered with more than one response. Table 2 gives the demographic details of the study group. Of the 40 responders, 30 had children and 10 did not. Fifteen women smoked an average of eight cigarettes per day, the remainder were nonsmokers. The commonest preoperative bra cup size was 'A' and postoperatively 'C' (Table 3). The commonest size of implant inserted was 240 cc (range cc). A total of 60% (24/40) of women in the study had considered breast augmentation for at least 2 years prior to surgery but 40% (16/40) had only considered it recently. Of all the women, 95% (38/40) reported that they were motivated to go ahead with breast implants for themselves, rather than to please a partner or to find a new partner. With regard to information as to the risks and benefits of breast implants, a combination of sources of information were used by the study group (Table 4). Health concerns resulting from silicone gel-filled implants were well known to them, with 97.5% (39/40) being aware of reports in the media. The concerns were thought justified by 72.5% (29/40) of women, while 17.5% (7/40) did not think that they were and a further 10% (4/40) were uncertain. Asked why they had chosen to have soyabean Table 2 Demographic details No. of questionnaires sent No. of replies to questionnaire No. attending for clinical assessment Mean age (years) at operation Mean follow-up period (months) Table 3 Preoperative size Pre- mad postoperative bra cup sizes Postoperative size A 26 A 0 B 10 B 11 C 4 C 23 D 0 D 6 Table 4 Information sources (range 22-53) 14 (range 6-24) No. % Magazines Television Radio 6 15 Talking with friends Scientific journals The Internet Table 5 Why did you choose soyabean oil-filled implants? No. % Concern about silicone Following discussion with surgeon Concern about mammography Advised by friends with triglyceride implants Problems with existing silicone implant oil-filled breast implants, 72.5% (29/40) of women were concerned about silicone health issues (Table 5). Despite having some concerns about a triglyceride oil-filled implant with a silicone shell, the majority of women (31/40) expressed the view that they felt the Trilucent TM implant was the 'lesser of two evils'. At the time of review 90% (36/40) said that they would undergo such surgery again, or advise their friends to have the operation if they were asked for an opinion. Overall satisfaction was reported as follows: very pleased 45% (18/40), pleased 32.5% (13/40), content 12.5% (5/40), displeased 7.5% (3/40), very unhappy 2.5% (1/40). Skin wrinkling is a potential problem with Trilucent implants as they are somewhat under filled. However, although some wrinkling was palpable in a number of patients examined, it was not a particular complaint of women in this study. Patient assessment of the appearance of the implanted breasts (Table 6) showed a high degree of patient satisfaction. Of our study group 82.5% reported that they had Table 6 Patient assessment of breast implants Assessment No. % Size Too big 2 5 Ideal Too small Shape Excellent Satisfactory Not quite right 6 15 Very poor Firmness Natural Slightly firm Firm Hard 0 0 Nipple position Exactly right Uneven Too high 0 0 Too low Nipple sensation Normal A bit numb Quite numb 4 10 Completely numb 0 0 Comfort of-implant Very comfortable Uncomfortable sometimes Always uncomfortable 0 0 Scars Invisible Visible Raised/stretched Terrible Table 7 Lifestyle and body image Confidence More Same Less Body image Enhanced Same Less Sex appeal to partner Increased Same Less Sex life Positively Same Negatively Clothes More revealing Same Less revealing Personality More outgoing Same More inhibited

3 Patient satisfaction with Trilucent TM breast implants 481 Table 8 Postoperative capsule formation Baker's grading Surgeon Nurse I 5 8 II III 0 0 IV 0 0 Table 9 Postoperative scarfing Resultant scar Surgeon (%) Nurse (%) Excellent 20 (53) 28 (74) Satisfactory 15 (39) 10 (26) Poor 3 (8) 0 Keloid/hypertrophic 0 0 an enhanced body image and this appears to have had a positive effect on their lifestyle (Table 7). Capsular contracture and postoperative scarring All the patients were assessed as having an acceptable result (Grades I or II) with regard to capsule formation, by both observers (Table 8). Clinical evaluation of the scars showed a high degree of acceptability of the resultant scar from both observers (Table 9). Of the 38 scars examined, 30 (79%) were in the submammary position and 8 (21%) in the axilla. Discussion The original concept of a radiolucent breast implant was conceived because of concern about the amount of breast parenchyma obscured by saline and silicone gel-filled implants on routine mammographic screening. Displacement techniques employed by radiologists may not be adequate when capsular contracture prevents adequate displacement. 4 Up to 83% of breast parenchyma may be obscured by saline or silicone gel-filled implants. 5 Triglyceride-filled implants have an effective atomic number closer to that of carbon, the main constituent of breast tissue, than saline or silicone and so have greater radiolucency. 6 Early concerns over the safety of silicone gel-filled implants 7 have not been substantiated. 8'9 However, concern has simultaneously arisen as to the 'rancidity' or stability of triglyceride oil-filled implants 1~ within the body after a period of years. The peroxide value of an oil is the closest correlation to rancidity and is a measure of the oxidation of the oil. Oil peroxidation within a breast implant is reported as being minimal and within limits considered clinically safe. ll Triglyceride oils do bleed across the silicone shell of implants 12 but there are no reported cases of immune-mediated problems. 11 Further concern about the theoretical risk of fat embolisation from rupture of a triglyceride implant has been raised, although it is thought unlikely that this would cause serious consequences. 13 The acquisition of information that led to the initial consultation to request breast augmentation was, for the majority of women in our study, from magazines (6.5%) and from talking with friends (57.5%). It is interesting that in this group of women 25% had sought information from the Intemet; a source of information for patients which will surely grow in importance in the next few years. Despite concern over the safety of breast implants, the women in this study were willing to undergo breast augmentation with a triglyceride implant and the majority, 90% (36/40), were satisfied with the results of surgery. The 7.5% (3/40) that were displeased and 2.5% (1/40) who were very displeased with the results of implant placement cited asymmetrical differences between the breasts and firmness as the cause of their dissatisfaction. No deflations were seen in this study group. However others have observed deflation associated with inflammation, and discolouration of the skin overlying the ruptured implant. Surgical exploration is reported to reveal a milky fluid in the implant pocket comprising soaps of calcium salts and fatty acids; once removed the inflammation of the skin is said to resolve. 14 The choice between a silicone or a triglyceride implant would for the majority of our study group (67.5%) appear to be one of concern over silicone-related health issues. This may reflect the negative image portrayed by the media over this issue, despite large trials being unable to show silicone as a predisposing factor for immune-related illnesses. 3 A total of 65% of the women reported that the preoperative discussion with the surgeon was a major factor in their decision. This can be no surprise as informed consent from the operating surgeon should clarify and modify the patient's preoperative thoughts about surgery. In this study, women were offered equally the choice between triglyceride, saline or silicone implants. The information given to the patient as part of the process of informed consent consisted of a preoperative discussion with the surgeon, a patient information sheet outlining the current scientific knowledge as to the risks and benefits of each type of implant and references to scientific papers, if requested. Interestingly, only 30% of women reported that a major reason for choosing a triglyceride implant was concern over mammographic imaging, the reason they were developed in the first instance. Overall satisfaction with triglyceride implant placement appears to be high although 27.5% of women complained that the implants were sometimes uncomfortable, usually associated with breast enlargement towards the middle of their menstrual cycle. In conclusion, women in this study receiving Trilucent TM breast implants were pleased with the overall results of their surgery. Despite clinical trials refuting earlier concerns over immune-mediated illnesses caused by silicone implants, for some women it would appear that the public reputation of silicone may have been forever blighted. Whether silicone-related issues are a concem or not, a proportion of women will prefer a radiolucent implant to reduce interference with mammography. Longer clinical follow-up of the Trilucent TM implant is awaited with interest. Addendum In March 1999, following discussions between the manufacturers, the Medical Devices Agency and the NHS execu-

4 482 tive, Trilucent TM implants were voluntarily withdrawn from the market, t5 Concerns centred around the stability of the lipid oil used as a filler in the wake of anecdotal reports of unilateral breast swelling associated with inflammation which, when explored, revealed a ruptured implant, the capsule being filled with opaque oil with a British Journal of Plastic Surgery rancid smell. Questions were raised about the original toxicological studies carried out on the soyabean oil. The senior author (BMJ) wrote a detailed letter to all 75 patients who had TrilucentTM augmentation under his care offering to review them in clinic (a further five patients could not be contacted since they had moved or lived abroad). A total of 29 responded and were seen. None had (or have since) suffered the symptoms of swelling outlined above. However, in five patients there was a capsular contracture of a kind not previously seen with other implants in that it was lumpy in nature rather than being universally firm, feeling somewhat like multiple fibroadenomata. Three patients have undergone surgical re-exploration (at the manufacturer's expense) at 34, 30 and 33 months after the initial surgery. One patient is awaiting surgery and the last has deferred treatment since she has coincidentally developed nephrotic syndrome. At operation the implant was found to be intact in each case but surrounded by a dense fibrous capsule through which the implant shell had herniated in places giving rise to the lumpiness noted on palpation (Fig. 1A, B). The Trilucent implants were replaced with anatomic cohesive silicone gel implants (McGhan). The manufacturers (now under new ownership) have instituted a continuing research programme into the longterm stability of soyabean oil and the Medical Devices Agency continues to collect clinical data in cooperation with the National Breast Implant Registry. Problems of swelling, inflammation and rancidity have not been seen in this study but the lumpy capsular contracture is unique to TrilucentT M implants in the authors' experience. Monitoring of this cohort of patients will continue and true long-term outcome studies are awaited with interest. The problems associated with these and other implants focus attention on the adequacy of pre-clinical testing and approval of implantable medical devices when compared with pharmaceuticals for which there is a much more rigorous regime. Acknowledgements We would like to thank Practice Nurse Janette Karaphillides for her help in the clinical assessment of subjects and Gill Belshaw for her clerical and administrativeassistance. References Figure 1--(A) Explanted TrilucentTM implant and capsule intact showing 'rippled' lumpy appearance. (B) Capsule opened showing degeneration/separationof texturing. 1. Cooper C, Dennison E. Do silicone breast implants cause connective tissue disease? BMJ 1998; 316: Park AJ, Chetty U, Watson ACH. Patient satisfaction following insertion of silicone breast implants. Br J Plast Surg 1996; 49: Nyren O, Yin L, Josefsson S, et al. Risk of connective tissue disease and related disorders among women with breast implants: a nation-wide retrospective cohort study in Sweden. BMJ 1998; 316: Handel N, Silverstein MJ, Gamagami P, Jensen JA, Collins A. Factors affecting mammographic visualization of the breast after augmentation marnmaplasty.jama 1992; 268: Hayes H Jr, Vandergrift J, Diner WC. Mammography and breast implants. Plast Reconstr Surg 1988; 82: Young VL, Diehl GJ, Eichling J, Monsees BS, Destouet J. The relative radiolucencies of breast implant filler materials. Plast Reconstr Surg 1993; 91: Kessler DA. The basis of the FDA's decision on breast implants. N Engl J Med 1992; 326:

5 Patient satisfaction with Trilucent TM breast implants Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective-tissue diseases in female health professionals: a retrospective cohort study. JAMA 1996; 275: Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton LJ III. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 1994; 330: Barnett MP. Triglyceride-filled breast implants. Plast Reconstr Surg 1997; 99: Young VL. Triglyceride filled breast implants: Reply. Plast Reconstr Surg 1997; 99: Young VL, Lund H, Ueda K, Pidgeon L, Schorr MW, Kreeger J. Bleed of and biologic response to triglyceride filler used in radiolucent breast implants. Plast Reconstr Surg 1996; 97: Young VL, Lund H, Destouet J, Pidgeon L, Ueda K. Biocompatibility of radiolucent breast implants. Plast Reconstr Surg 1991; 88: Opitz Per G, Young VL. Experience with soybean oil-filled breast implants in Swedish surgical practice. Aesthetic Surg J 1998; 18: Austin A. Adverse incident reporting to the Medical Devices Agency - a review of reports involving Trilucent breast implants. Br J Plast Surg 2000; 53: The Authors Anthony P. Armstrong FDSRCS, FRCS(Plast), Fellow in Aesthetic Surgery Barry M. Jones MS, FRCS, Consultant Plastic and Reconstructive Surgeon Department of Plastic and Reconstructive Surgery, The Wellington Hospital, London, UK. Correspondence to Mr B. M. Jones, 14A Upper Wimpole Street, London W1M 7TB, UK. Paper received 27 January Accepted 10 May 2000, after revision. Editor's footnote: Since the acceptance of this paper, the Medical Devices Agency has published a hazard notice MDA HN2000(05) advising that all women implanted with Trilucent implants should be advised to consider having them removed because of evidence to suggest that the concentration of breakdown products from the soyabean oil filler material was much higher than the concentration normally found in the body and the possibility of genotoxicity.