Patient satisfaction following insertion of silicone breast implants

&;thh

Journd

of Pkrstic

0 1996 The British

Surgq

Association

( 1996), 49, 5 15 518 of Plastic Surgeons

Patient satisfaction following insertion of silicone breast implants A. J. Park, U. Chetty” and A. C. H. Watson Department of Plastic and Reconstructive Surgery, St. John’s Hospital, Livingston, *Breast Unit, Western General Hospital, Edinburgh, UK

West Lothiun and

SUMMAR Y. Because of allegations linking silicone implants with cancer and connective tissue diseases and mounting media coverage, women with silicone breast implants are extremely concerned, despite the lack of evidence showing a link between silicone gel-filled breast implants and connective tissue diseases or cancer. To assess whether or not this group of women were satisfied with their operations, we sent all women who had silicone breast implants inserted in the south-east of Scotland between 1982 and 1991 a quality of life questionnaire. One hundred and two breast augmentation and 212 breast reconstruction patients replied. Not everyone answered every question. The majority of women in our study, 84% (79/94) and 91.8% (192/209) of augmented and reconstructed patients, respectively, stated that they were satisfied with their operations, although only about half were very satisfied. Although 91.2% (270/296) of all the women were aware of the allegations with 29.7% (88/296) concerned, only 3% (9/296) of all the women felt that there was cause for concern. It would appear that, although most women with silicone breast implants are aware of the accusations regarding silicone and systemic illnesses, the adverse publicity has only given a small number of them a cause for concern and the majority are satisfied with the outcome of their operation and perceive the benefits to outweigh the risks.

Surgical implantation of plastic materials for reconstruction or augmentation of the breast became popular following the development in 1964 of the modern silicone implant.’ Before the use of implants, developmental abnormalities of the breast were corrected by less satisfactory means using transplanted fat tissue or implantation of other synthetic materials such as sponges, or injecting silicone or paraffin. Silicone implants are used to reconstruct the breast following mastectomy for breast cancer, to correct congenital or traumatic deformities or to enlarge or reshape the breast for cosmetic reasons. The psychological benefits of these procedures are well recognised.2-4 Recent worldwide press and media speculation that silicone implants may be linked to an increased incidence of breast cancer, other cancers and connective tissue diseases is a current cause for concern to the medical profession and public alike. In response to this, the Food and Drug Administration in the USA has banned the use of silicone gel-filled breast implants for cosmetic purposes, except through controlled clinical trials, until their safety has been proven.5 However, in the UK the Department of Health found no conclusive evidence of an increased risk of connective tissue diseases in this group of women and, therefore, no scientific case for any change in practice or policy.6.7 However, because of these allegations and mounting media coverage, women with silicone breast implants are extremely concerned despite the lack of evidence showing a link between silicone gel-filled breast implants and connective tissue diseases or cancer.8m19

To assesswhether or not this group of women were satisfied with their operations, we sent all women who had silicone implants inserted in the south-east of Scotland between- 1982 and 1991 a quality of life questionnaire. Patients and methods Two separate groups of patients were studied. 1. Breast augmentation This group consisted of all patients in the south-east of Scotland who had a silicone gel-filled breast implant inserted for reasons other than reconstruction following mastectomy for cancer between the years 1982 and 1991, inclusive. The operations were all performed at the Regional Plastic Surgery Unit at Bangour General Hospital (now St. John’s Hospital, Livingston), West Lothian. The names of these patients were found in the operating books and the patients were then contacted to take part in the study. If no reply was received, another letter was sent and, if after this there was still no reply, their General Practitioner was contacted in case they had changed their address. The non-attendees had either moved house and lived too far away or did not wish to take part in the study. 2. Breast reconstruction This group consisted of all patients in the south-east of Scotland who had a silicone gel-filled breast 515

516

British

Table 1

Summary

of some

1. Which of the following & feel right now? Like a natural uncomfortable, very unnatural

of the

questions

best describes

asked

how

your

breasts

look

part of my body, a bit unnatural but not somewhat unnatural and uncomfortable and uncomfortable

2. How would you rate the appearance result of your enlargement?

of your

breasts

or

as a

Much better than I expected, better than I expected, just what I expected, worse then I expected or much worse than I expected 3. How do your breasts feel right now? Soft and natural,

slightly

4. If you described firmn moderately firm or hard, Not

at all, not very,

firm,

moderately

or hard

@ur breast as slightly firm, how bothersome is this to you?

somewhat,

5. Have you ever had medical breasts? If yes, what?

firm,

very

treatment

for firmness

Closed capsulotomy (when the doctor squeezes to break up the scar tissue), open capsulotomy surgically break down the scar tissue), implant other 6. How Almost

would

you

invisible,

rate the appearance moderately

7. Overall how satisfied reconstruction?

of your

invisible,

are you with

very

your

your breast (to replacement, scars?

visible

breast

Very satisfied, more satisfied than dissatisfied, dissatisfied than satisfied, very dissatisfied

in your

augmentation/ more

8. Are you aware of any allegations made against silicone? As a result of anything you may have read or any problems you may have experienced, what health concerns, if any, do you have about your breast implants? 9. How

long did you

10. How satisfied breast?

wait to have

are you with

your

the look

reconstruction? of your

Very satisfied, more satisfied than dissatisfied, dissatisfied than satisfied, very dissatisfied 11. What is your occupation? How Do you smoke cigarettes/drink

many children alcohol?

reconstructed more do you

have?

implant inserted for breast reconstruction following mastectomy for breast cancer over the same lo-year period. These operations were performed at the same plastic surgery unit as above and at the Breast Unit at the Western General Hospital, Edinburgh (formerly at Longmore Hospital, Edinburgh). The names of the patients were extracted from the database of patients in the Breast Unit. The nonattendees had either moved out of the area, did not wish to participate or had died. A similar quality of life questionnaire was sent to patients from each group. Questions were asked about appearance of breasts, how natural the breasts felt, firmness, scars, and overall satisfaction. The patients were also questioned about media awareness and concerns. Help in devising the questionnaire was sought from the breast care nurse. Questions required either a yes/no response or were in the form of a scale. Written comments were also encouraged. Table 1 summarises some of the questions asked. Ethical approval was granted from the Ethics of

Journal

of Plastic

Surgery

Medical Research Sub-committee for Surgery of the Lothian Health Board. Results

Questionnaires were sent to 186 women following breast augmentation and 289 following breast reconstruction with a silicone implant. Table 2 gives the numbers, age ranges and means for each of the two groups of women. The replies totalled 102 and 212 from the augmentation and reconstruction groups respectively. Not everyone answered all of the questions. The majority of the women were employed, 74% of the augmentation group and 61.7% of the reconstruction group. 64.2% of the augmentation group and 73.6% of the reconstruction group had at least one child. 59.3% of the augmentation group and 30.4% of the reconstruction group smoked cigarettes. The time from mastectomy to breast reconstruction is shown in Table 3. 61.2% ( 126/206) had an immediate reconstruction, with only 3% (6/206) reconstructed after 5 years. This reflects the policy of the Breast Unit where all women are offered immediate breast reconstruction. Knowledge of current allegations regarding implant safety The majority of women were aware of the allegations regarding the safety of silicone implants (9 1.2% : 270/ 296). However, very few actually believed there to be a problem (3% : 9/296), although more women were concerned (29.7% : 88/296). These were mainly the women who had undergone augmentation rather than reconstruction (50.0% v. 20.6% : 46192 v. 42/204). Satisfaction with implants The following two questions were only asked to the augmentation group: Which of the following best describes how your breasts look and feel right now? 60% (54/90) of the augmentation women felt that their breasts felt ‘like a natural part of my body’, 26.7% (24/90) thought they felt ‘a bit unnatural but not uncomfortable’, 12.2% (1 l/90) thought of them as ‘somewhat unnatural and uncomfortable’ and only 1.I% (l/90) felt them ‘very unnatural and uncomfortable’. When asked to rate the appearance of their breasts, the augmentation group women felt they were ‘much better than expected’ in 28.6% (26/91), ‘better than Table 2

No. Mean Age No. Mean Age

sent questionnaires age (years) range of replies age (years) range

Augmentation

Reconstruction

186 34.1 14-60 102 25.4 14-56

289 55.2 24-82 212 47.5 24-68

Silicone breast implants

517 Table 5 No. of women who found firmness bothersome

Table 3 Tim

of reconstruction

Immediate < I year l-5 years 6 IO years > IO years

No.

1%

126 44 30 3 3

61.2 21.4 14.6 1.5 1.5

expected’ in 26.4% (24/91), ‘just what I expected’ in 33% (30/91), ‘worse than expected’ in 9.9% (9/91) and ‘much worse than expected’ in only 2.2% (2/91). It was felt that these two questions were not relevant to the reconstructed group and this group of women were therefore asked a similar but differently worded question. They were asked: ‘How satisfied are you with the look of your reconstructed breast?’ 42.5% (90/212) were ‘very satisfied’, 48.1% ( 102/212) were ‘more satisfied than dissatisfied’, 6.6% (14/212) ‘more dissatisfied than satisfied’ and only 2.8% (6/212) were ‘very dissatisfied’. Both groups were then asked about the firmness of their implanted breasts. Their replies are summarised in Table 4. Approximately three quarters of the women in each group answered either ‘soft and natural’ or ‘slightly firm’ for each implanted breast. No higher than 10.5% had at least one hard breast. If they described the breasts as being anything but soft and natural, they were asked how bothersome this was. 39.4% (52/132) of reconstructed women and 33.3% (23/69) of augmented women replied that it did not bother them at all and only 1.5% and 7.2% felt very bothered (Table 5). 15% of reconstructed women said that they had medical treatment for firmness of the breasts compared with 23.5% of the augmented women. The treatment received is shown in Table 6. The women were then asked about the appearance of their scars (including mastectomy and reconstruction scars). Obviously the scarring is different in these two groups of patients. In the reconstruction group, 28.1% (59/210) thought that their scars were ‘almost invisible’, 50.5% ( 106/210) that they were ‘moderately invisible’ and 21.4% (45/210) ‘very visible’. In the augmentation group, 55.4% (51/92) felt that their scars were ‘almost invisible’, 34.8% (32/92) ‘moderately invisible’, and 9.8% (9/92) ‘very visible’. Both groups were then asked ‘overall, how satisfied are you with your augmentation/reconstruction?’ Table 7 summarises the replies. Overall, almost half of each group were very satisfied with their operations and 84% of augmented Table 4

Breast firmness

Augmentation Right 85 Left 86 Reconstruction Right 125 Left 115 (bilateral n = 28)

Soft & natural Slightly firm Moderately firm Hard Soft & natural Slightly firm Moderately firm Hard

44 23 11 7 57 37 24 7

(51.8) (27.1) (12.9) (8.2) (45.6) (29.6) (19.2) (5.6)

33 30 14 9 53 29 27 6

(38.4) (34.9) (16.3) (10.5) (46.1) (25.2) (23.5) (5.2)

after describing their breasts as being anything but soft and natural Augmentation (69 replies)

Not at all Not very Somewhat Very Not at all Not very Somewhat Very

Reconstruction ( 132 replies)

Table 6

Medical

treatment

Augmentation (24 replies)

Table 7

(33.3%) (29%) (30.4%) (7.2%) (39.4%) (34.1%) (25%) ( I .5%)

6 6 I I 1 2 9 19 I

(25%) (25%) (45.8%) (4.2%) (6.5%) (29%) (61.3%) (3.2%)

47 32 13 2 96 96 12 5

(50%) (34”/;1) (13.8%) (2.1%) (45.9%) (45.9%) (5.7%) (2.4%)

for breast firmness

Closed capsulotomy Open capsulotomy Implant replacement Other Closed capsulotomy Open capsulotomy Implant replacement Other

Reconstruction (3 I replies)

23 20 21 5 52 45 33 2

Overall satisfaction

Augmentation (94 replies)

Reconstruction (209 replies)

Very More More Very Very More More Very

satisfied satisfied than dissatisfied dissatisfied than satisfied dissatisfied satisfied satisfied than dissatisfied dissatisfied than satisfied dissatisfied

women and 91.8% of reconstructed women were more satisfied than dissatisfied. Discussion The Food and Drug Administration in the USA has banned the use of silicone gel-filled breast implants for cosmetic purposes, except through controlled clinical trials, until their safety has been proven5 following allegations that they cause connective tissue disease and cancer, despite no scientific evidence to confirm this. Large sums of money are being awarded by jurors to women who blame ill health on silicone despite no scientific evidence linking the illnesses to the implants. 20,21 In response to this, the larger implant manufacturers agreed to a global settlement to settle these cases out of court as they were clearly not being given fair hearings within it. This was given approval in September 1994 with a fund of $4.25bn to compensate women worldwide.22 However, since then, Dow Corning, who are named in approximately 2000 lawsuits by women who claim that their implants leaked silicone into their bodies causing damage, have filed for bankruptcy23 and have withdrawn from the global settlement. This was renegotiated in November 1995 and is still awaiting final approval.24 In response, the media have sensationalised this, resulting in the understandable anxiety and worry experienced by a number of women with silicone breast implants. Despite this, the majority of women in our study, 84% and 91.8”/0 of augmented and

British

518

reconstructed patients respectively, stated that they were satisfied with their operations, although only about half were very satisfied, and 60% felt that their breasts were like a natural part of their body. Only 10% felt that they were much worse than expected. Although 91.2% of all the women were aware of the allegations with 29.7% concerned, only 3.0% of all the women felt that there was cause for concern. Firmness in at least one breast was only felt to be a major problem in 7.2% and 1.5% of augmented and reconstructed women respectively. Of those who required treatment for firmness, the commonest operation performed was removal of the implant and replacement with another. The scarring from these two quite different procedures do not seem to present any problems with 90.2% of the augmentation group and 78.6% of the reconstruction group stating that the scarring was either almost or moderately invisible. This included the mastectomy and reconstruction scars. This study is in keeping with other published reports that the majority of women are satisfied with their breast implants. 25*26However, in this study all of the patients were then reviewed in a clinic by a plastic surgeon and were, therefore, able to ask about difficult questions within the questionnaire. 73.4% of the reconstructed group and 54.8% of the augmented group who were sent a questionnaire replied. This is a good return rate, with age ranges similar to those who did not reply. In conclusion, it appears that although most women with silicone breast implants are aware of the accusations regarding silicone and systemic illnesses, the adverse publicity has only given a small number of them a cause for concern and the majority are delighted with the outcome of their operation and perceive the benefits to outweigh the risks. It is therefore important that general practitioners, breast counsellors and other professionals involved in the counselling of this group of women are knowledgeable in the risks and up-to-date research refuting the allegations that silicone causes systemic disease, in order that the benefits of breast augmentation and reconstruction can be given to this group of deserving women and to prevent unnecessary anxiety. Acknowledgements Grants

supplied

by Tenovus-Scotland

and Sarah

Percy

Fund.

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The Authors A. J. Park MB, ChB, FRCS, Registrar in Plastic Surgery, City General Hospital, Stoke-on-Trent U. Chetty MB, ChB, FRCS, MRCP, Consultant Surgeon, Breast Unit, Western General Hospital, Edinburgh A. C. H. Watson MB, ChB, FRCSEd, Consultant Plastic Surgeon, St. John’s Hospital, Livingston, West Lothian. Correspondence Surgery, City

to Mr General

Alan J. Park, Department of Hospital, Stoke-on-Trent, UK.

Paper received 21 March 1996. Accepted 8 August 1996, after revision.

Plastic