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COSMETIC SECTION: COSMETIC

A Prospective Analysis of Patients Undergoing Silicone Breast Implant Explantation

Rohrich, Rod J. M.D.; Kenkel, Jeffrey M. M.D.; Adams, William P. M.D.; Beran, Samuel M.D.; Conner, William Chad H.

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Plastic and Reconstructive Surgery: June 2000 - Volume 105 - Issue 7 - p 2529-2537
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Abstract

Augmentation/reconstructive mammaplasty has been one of the most common surgical procedures performed by plastic and reconstructive surgeons. Until a voluntary moratorium took effect in 1992, a silicone prosthesis was the preferred device whenever an implant was needed. The biologically inert nature and physical properties of this compound made it an ideal choice for simulating breast tissue. However, concern over these implants began to increase in the early part of this decade with reports of a possible link between silicone and the development of several connective tissue diseases. Since then, many investigators have published numerous epidemiologic and basic science studies that continue to fail to show an increased risk of autoimmune disease in these women. 1–7 An extensive review of the literature by the Institute of Medicine concluded that “the toxicology studies of silicones and other substances known to be in breast implants do not provide a basis for health concerns.”8–11

Despite the lack of a scientifically proven link between silicone implants and disease, many women have chosen to have their implants removed. Unfortunately, there are few studies in the literature that have investigated the outcome of explantations, and there are no prospective analyses of the effect explantation has on a patient’s general health. 12–18 As such, it is difficult for plastic surgeons to predict which patients will benefit from explantation and to quantify that benefit. The goal of this study was to use a prospective database to determine whether there were any preoperative parameters that could be used to predict which patients would be improved following removal of silicone breast implants and to provide a quantifiable measure of that improvement.

Materials and Methods

Patient Enrollment

A total of 38 patients with silicone breast implants underwent operative removal of their implants by faculty at the University of Texas Southwestern Medical Center between 1996 and 1998. With the exception of those who did not want to participate in the study, patients were consecutive. Primarily, these women were concerned about systemic illnesses that might result from silicone breast implants; however, none had any documented rheumatic diseases at the time of evaluation. These patients underwent an independent consultation with their plastic surgeon as well as a research staff member. In addition to information regarding the surgical procedure and the study protocol, patients were given reprints of scientific articles on the safety of silicone breast implants. After initial consultation, patients who qualified could undergo (1) an explantation without reconstruction, (2) an explantation with replacement of saline-filled implants, (3) an explantation with a mastopexy, or (4) an explantation followed by a transverse rectus abdominis musculocutaneous flap. They were given questionnaires regarding several personal and medical parameters to be completed preoperatively, at 6 weeks postoperatively, and at 6 months postoperatively. In addition, their physicians completed preoperative and postoperative evaluations of the patients’ general health status. A control group of 38 patients with no history of breast augmentation was established; they were matched with the experimental group with regard to age, education, employment, and income. They were chosen randomly from women who responded to an advertisement posted throughout the University of Texas Southwestern Medical Center. Neither a desire for breast augmentation nor symptomatic complaints were used as selection criteria.

Assessment

Both the experimental and control patients completed extensive questionnaires that inquired as to basic demographic data, musculoskeletal symptoms, personal appearance evaluations, mental health, and their general feelings of well being. In addition, explant patients were queried as to how they felt their implants and subsequent explantation had affected their general health. The extensive lists of answers were then grouped according to standard subscales to evaluate physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, mental health, appearance evaluation, appearance orientation, illness orientation, and body-area satisfaction (Table I). Comparisons of these subscales were then made using the repeated measures analysis of variance technique for both experimental versus control over time and experimental alone over time. Also, stepwise regression was used to evaluate variables that may predict outcome of patients in the experimental group.

Table 1
Table 1:
Patient Evaluation Questions

Explantation Technique

Our explantation technique was individualized for specific patients based upon a systematic evaluation of the patient’s current breast appearance and aesthetic desires. Preoperative evaluation consisted of baseline mammography within 12 months with ultrasound and/or magnetic resonance mammogram, as described by Samuels et al., 18 and a comprehensive history and physical examination. Examination of the breast focused on five areas: (1) degree of preoperative ptosis, (2) the amount of breast tissue overlying the implant, (3) areola size, (4) size and position of the implant, and (5) degree of skin elasticity. The preferred incision for explantation was an inframammary incision because it gives the best exposure for implant and capsule removal. Every effort was made to remove the implant and capsule intact. Other incisions could be used if breast contouring with vertical incisions was planned.

After explantation, breast contouring was performed as appropriate. For patients who wished to maintain volume or increase volume, a subpectorally placed saline implant was generally used. Patients who had only pseudoptosis or none at all were good candidates for explantation alone. For patients with ptosis, various mastopexy techniques were used. Depending on their degree of ptosis, areola size, degree of residual breast tissue, and smoking habits, patients underwent inframammary fold wedge excision, periareolar mastopexy, a modified Kiel mastopexy, a wise pattern mastopexy, or a delayed mastopexy (see Table II). 19

Table 2
Table 2:
Ptosis Treatment Algorithm*

Results

Summaries of result values can be found in Tables III and IV. With regard to basic demographics, controls and experimental groups were matched with regard to age (48.36 control, 52.42 experimental), education (14.42 control, 14.24 experimental), employment, and income.

Table 3
Table 3:
Means and Standard Deviations (Control)
Table 3A
Table 3A:
Continued
Table 4
Table 4:
Means and Standard Deviations (Experimental)
Table 4A
Table 4A:
Continued

Statistical analysis revealed several statistically significant differences between the two groups. Comparison of physical functioning and physical role responses showed that controls were less limited by illness than the experimental group (p = 0.0018 and 0.0048). Bodily pain was higher in the experimental population (p = 0.0001). Also, controls had a more favorable evaluation of their general health than the experimental group (p = 0.0062). Physical health was also more likely to affect the social functioning of members of the experimental group than the controls (p = 0.0226). Next, the experimental group was more likely to accomplish less than they would like and not take as much care with work or other activities as the controls (p = 0.0223). Finally, the experimental group had a higher level of body area satis faction than controls (p = 0.031).

There were several areas where the pattern of responses over time between the two groups was significantly different relative to each other. First, the experimental group showed a decrease in the number of musculoskeletal symptoms at 6 weeks and 6 months postexplantation, whereas controls had a decrease and a subsequent increase in their musculoskeletal symptoms (p = 0.032). Likewise, the vitality of the experimental group increased consistently over time, whereas controls had no statistically significant change (p = 0.0179). This same pattern was seen with regard to improvement in mental health, with controls consistently improving over time (p = 0.0087). Finally, an improvement was seen in bodily pain (p = 0.0040) and body area satisfaction (p = 0.0471) for both groups over time.

There were no significant differences noted between the two groups with regard to their appearance evaluation, appearance orientation, or illness orientation.

When analyzing the experimental group, those who initially indicated a higher number of musculoskeletal symptoms and a higher appearance evaluation were more likely to indicate a significant improvement in general health since explantation (p = 0.0175 and 0.0233, respectively). However, there was no significant difference in their responses to the statements, “Removing my implants has improved my general health,” and “Removing my implants has reduced muscle and joint pain.” Also, those patients who reported a lower physical role were more likely to report being injured by their implants (p = 0.0052) and that their implants were making them sick (p = 0.0228). Finally, when looking at the responses of the experimental group alone over time, an initial decrease was seen in physical functioning at 6 weeks postoperatively, followed by an increase over baseline at 6 months postoperatively (p = 0.0335). This most likely represented initial recovery time from surgery followed by complete recovery.

Discussion

The results of this study provide insight into the differences between patients seeking explantation and a control population, how some of those differences change over time, and what are some of the effects that the removal of implants has on patients. Overall, patients who were seeking explantation were more likely to report a higher number of subjective musculoskeletal symptoms, lower physical functioning, lower physical accomplishments, higher levels of bodily pain, lower general health, and more interference with social and emotional roles than the standard population. Interestingly, these patients had a higher level of body area satisfaction than controls. In other words, despite their satisfaction with appearance and despite numerous studies demonstrating no link between breast implants and general health, these women had subjective complaints that were significant.

When evaluated over time and compared with controls, these patients showed improvement in the number of musculoskeletal symptoms, vitality, mental health, bodily pain, and body area satisfaction. There was statistically significant evidence that explantation does improve subjective health for patients who are distressed by their implants and have them removed.

Although we feel that this study adds important prospective information on explantation, there is still much work to be done to fully define the science of augmentation mammaplasty. Specifically, we plan to continue evaluating explant patients in hopes of finding some objective measures that would allow us to predict which patients would see the most improvement following explantation and which may be advised against surgery. Although we did see a significant relationship between a higher number of musculoskeletal symptoms and a feeling of improvement, this runs contrary to our previous retrospective evaluation, which showed that those with fewer symptoms correlated with a greater improvement. 20

The controversy over breast implants has been unfortunate and could have been avoided if members of the news media and legal professions had not engaged in alarmist and accusatory practices and allowed scientific investigation to proceed. Plastic surgeons have made every effort to adhere to the principle of “do no harm” in the care of their patients. Fortunately, the overwhelming scientific data have shown and continue to show that silicone breast augmentation/reconstruction seems to be safe. This study reveals that patients seeking explantation had higher levels of bodily pain and were more likely to be limited by their health concerns than a control population, and many of these parameters improved following explantation.

Unanswered questions remain as to whether the improvements seen by these patients are sustained at 1 year postoperatively or whether symptoms return. The conclusion drawn from this study, although contrary to a retrospective study, continues to reveal that we must listen to our patients whether they have silicone gel breast implants or not, and, if they want them removed, it is their choice. Interestingly, in our retrospective study we have noticed that 50 percent of those patients who had silicone gel implants removed subsequently underwent replacement with either saline or silicone after 2 years.

Acknowledgment

This study was funded by a grant from the Texas Advanced Research/Advanced Technology Program.

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