Will Breast Implants Improve Your Life?

By Diana Zuckerman, PhD

 

Despite the claims of plastic surgeons that breast implants improve patients’ self-esteem and quality of life, there is no scientific support for those statements.  The only scientific data available are from studies conducted by two breast implant companies, Allergan(formerly Inamed) and Mentor.  The companies were required to conduct the studies and provide the results to the FDA when the companies applied for FDA approval for their silicone gel breast implants.  The FDA then reviewed the results and reported them in a summary for each company’s data that is on the agency web site.

The studies included questionnaires for women just before they got breast implants and two years later.  The questionnaires included scientifically valid and reliable measures of self-esteem, self-confidence, and other measures of “quality of life,” including physical health, mental health, and social relationships.  There were three types of patients that were separately studied by each company: breast augmentation patients, breast reconstruction patients (using implants to replace breasts lost to mastectomy), and revision patients.  Revision patients were patients who already had breast implants that needed to be replaced with new implants, so they were studied when they had implants that had ruptured or caused other problems and were soon to get replacement implants, and two years after the implants had been replaced.  The results of those studies are below.

In summary, for Inamed augmentation patients, 12 quality of life scores differed significantly in the pre-test and post-test.  Nine of the 12 (75%) were worse in the post-test.  For Inamed revision patients9 of 9 (100%) that differed significantly were worse in the post-test.  For reconstruction patients, only two scores were significantly different in the post-test, and both showed improvement in physical functioning, which probably reflects the fact that many of these women were being treated for breast cancer at the pre-test and their quality of life was better as cancer survivors two years later.

Inamed (Allergan)

Here are the details from the FDA Summary Panel Memorandum from FDA’s Inamed PMA Review Team, March 2, 2005 (http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf)

“With respect to the Health Status Questionnaire (SF-36 and MOS-20), the core augmentation cohort….There were small, statistically significant declines in some subscales of these measures in breast implant recipients over time.  However, the 2-year values for the augmentation cohort were generally numerically higher than normative values for the general female population” (page 71).

Although the FDA summary does not mention it, most of the significant differences showed lower scores on quality of life in the post-test.  Nine of 12 were worse for augmentation patients and nine of 9 were worse for revision patients.

Quality of Life measures include the SF-36, which measures 8 health concepts: physical functioning; role-physical; bodily pain; general health; vitality; social functioning; role-emotional; and mental health.  The 8 scales can then be collapsed into two summary scales with the first 4 scales comprising the Physical, and the last 4 scales comprising the Mental Health.

Inamed Augmentation Patients

All Statistically Significant Changes are as follows:

  • SF-36 Role Emotional:  Significantly worse in post-test
  • SF-36 Role Physical:  Significantly worse in post-test
  • SF-36 General Health:  Significantly worse in post-test
  • SF-36 Social:  Significantly worse in post-test
  • SF-36 Vitality:  Significantly worse in post-test
  • SF-36 Mental Health:  Significantly worse in post-test
  • MOS-20 Health Perceptions:  Significantly worse in post-test
  • MOS-20 Mental Health:  Significantly worse in post-test
  • Tennessee Self-Concept Scale: Physical Self:  Significantly better in post-test
  • Body Esteem-Total Score:  Significantly better in post-test
  • Body Esteem-Sexual Attractiveness:  Significantly better in post-test
  • Body Esteem-Physical Condition:  Significantly worse in post-test
  • Scores on the Rosenberg Self Esteem Scale were worse in the post-test, but the difference was not statistically significant.

Allergan Reconstruction Patients

  • SF-36 Role Physical:  Significantly better in post-test
  • MOS-20 Physical Functioning: Significantly better in post-test

Inamed Revision Patients

  • SF-36 Role Emotional:  Significantly worse in post-test
  • SF-36 General Health:  Significantly worse in post-test
  • SF-36 Social:  Significantly worse in post-test
  • Mental Health: Significantly worse in post-test
  • MOS-20 Health Perceptions: Significantly worse in post-test
  • MOS-20 Mental Health: Significantly worse in post-test
  • Tennessee Self-Concept Scale Physical Self:  Significantly worse in post-test
  • Rosenberg Self-esteem Scale:  Significantly worse in post-test
  • Body Esteem-Physical Condition:  Significantly worse in post-test

Mentor

Below are the data from the FDA Summary Panel Memorandum from FDA’s Mentor PMA Review Team, March 2, 2005 (http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_Tab-1_fda-Mentor%20Panel%20Memo.pdf)

Similar to the Inamed findings, when there were statistically significant changes from pre-test to post-test for Mentor patients, almost all were worse in the post-test compared to the pre-test.  For augmentation patients, scores on physical health and mental health were significantly worse, scores on the Rosenberg self-esteem scale were better, and there was no change on the Tennessee self-concept scores or body esteem scale.  For revision patients, scores on physical health, mental health, body esteem and Tennessee self-concept scale all were worse in the post-test, and there was no change in the Rosenberg self-esteem scale.  No scores were better in the post-test.  For reconstruction patients, there were no significant changes on any of the scales.

The data below are not as detailed as the Inamed data, because the FDA memo did not provide as much specific information.  However, it includes differences in scores that were provided by the FDA.

Mentor Augmentation Patients

  • Physical Health: Significantly worse in post-test (1.0)
  • Mental Health: Significantly worse in post-test (1.1)
  • Tennessee self-concept scores: No significant change
  • Body Esteem scale: No significant change
  • Rosenberg Self-Esteem Scale: Significantly better in post-test (0.6)

Mentor Reconstruction Patients

  • Physical Health: No significant change
  • Mental Health: No significant change
  • Tennessee Self-Concept Scale: No significant change
  • Body Esteem Scale: No significant change
  • Rosenberg Self-esteem Scale: No significant change

Mentor Revision Patients

  • Physical Health: Significantly worse in post-test (1.8)
  • Mental Health: Significantly worse in post-test (2.5)
  • Tennessee Self-Concept Scale: significantly worse in post-test (6.6)
  • Body Esteem Scale: significantly worse in post-test (5.0)
  • Rosenberg Self-esteem scale: no significant change

FDA also noted the following about the literature review on Quality of Life information (provided by Mentor):

  • Page 70: “…the literature does not provide strong scientific support that breast implants have measurable psychological and psychosocial benefits for women seeking breast augmentation.”
  • Page 73: “Literature that adequately evaluates the short-term or long-term psychological or psychosocial benefits of breast implants as a reconstructive procedure utilizing appropriate control group was not provided by Mentor.”

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