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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 Allergan augmentation patients, 12 quality of life scores differed significantly in the pre-test (before implants) and post-test (2 years after implants).  Nine of the 12 (75%) were worse after getting implants.  For Allergan revision patients9 of 9 (100%) that differed significantly were worse after getting their replacement implants.  For reconstruction patients, only two scores were significantly different after getting breast implants, 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.

Allergan (Inamed)

Here are the details from the FDA Summary for women with Allergan (Inamed) breast implants. (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  after getting implants.  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, a scientifically valid measure of 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 after getting implants
  • SF-36 Role Physical:  Significantly worse after getting implants
  • SF-36 General Health:  Significantly worse after getting implants
  • SF-36 Social:  Significantly worse after getting implants
  • SF-36 Vitality:  Significantly worse after getting implants
  • SF-36 Mental Health:  Significantly worse after getting implants
  • MOS-20 Health Perceptions:  Significantly worse after getting implants
  • MOS-20 Mental Health:  Significantly worse after getting implants
  • Tennessee Self-Concept Scale: Physical Self:  Significantly better after getting implants
  • Body Esteem-Total Score:  Significantly better after getting implants
  • Body Esteem-Sexual Attractiveness:  Significantly better after getting implants
  • Body Esteem-Physical Condition:  Significantly worse after getting implants
  • Scores on the Rosenberg Self Esteem Scale were worse  after getting implants, but the difference was not statistically significant.

Allergan Reconstruction Patients

  • SF-36 Role Physical:  Significantly better after getting implants
  • MOS-20 Physical Functioning: Significantly better after getting implants

Inamed Revision Patients

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

Mentor

Below are the data from the FDA Summary for women with Mentor breast implants (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 (before implants) to post-test  (after implants) for Mentor patients, almost all were worse after getting breast implants compared to before getting implants.  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 after getting breast implants, and there was no change in the Rosenberg self-esteem scale.  No scores were better after getting their breast implants replaced, even though problem implants were replaced with new ones.  For reconstruction patients, there were no significant changes on any of the scales.

The data below are not as detailed as the Allergan (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 after getting implants (1.0)
  • Mental Health: Significantly worse after getting implants (1.1)
  • Tennessee self-concept scores: No significant change
  • Body Esteem scale: No significant change
  • Rosenberg Self-Esteem Scale: Significantly better after getting implants (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 after getting implants (1.8)
  • Mental Health: Significantly worse after getting implants (2.5)
  • Tennessee Self-Concept Scale: significantly worse after getting implants (6.6)
  • Body Esteem Scale: significantly worse after getting implants (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.”

In summary, whether women were getting breast implants for augmentation, reconstruction after having a mastectomy, or to replace breast implants that had broken or were not satisfactory for whatever reason, on most measures of the quality of their lives the women were worse after getting breast implants.  There were a few improvements but they were outnumbered by aspects of their lives that they felt worse about or that didn’t change after spending thousands of dollars for plastic surgery.

Breast Implants: Terms to Know

Some breast implant related terms

Anaplastic Large Cell Lymphoma (ALCL): A type of cancer that can be caused by breast implants

Augmentation: placement of a breast implant in order to increase the size of a healthy breast

Autoimmune Disease: chronic, sometimes deadly diseases when the body develops antibodies to it’s own tissue, such as rheumatoid arthritis, lupus, scleroderma, and multiple sclerosis

Capsule: the body reacts to the implant by surrounding it with scar tissue, to protect the body from the foreign object. This forms a capsule of scar tissue around the implant.

Capsular Contracture: when the scar tissue capsule around implant becomes too small for the implant, it feels tight and makes the breast feel harder. This can be painful and distort the shape of the breast.

Capsulectomy: removal of scar tissue capsule whether or not implants are removed

Closed Capsulotomy: use of non-surgical, manual pressure on the breast in order to break up the tight scar tissue around the implant. This procedure often ruptures the implant and is therefore no longer recommended.

Connective Tissue Disease: chronic inflammatory diseases that are autoimmune in origin, such as rheumatoid arthritis, systemic lupus, or scleroderma

En Bloc: A type of breast implant removal where the capsule and implants are completely removed together

Envelope: the silicone shell that contains the saline or silicone gel of a breast implant

Explantation: surgical removal of breast implants

Extracapsular Rupture: when silicone from a ruptured gel implant leaks out of the scar tissue capsule into the breast or elsewhere in the body

Fibromyalgia: a little-understood syndrome characterized by chronic pain

Gel Bleed: when silicone leaks out of the silicone envelope without a rupture in the implant

Gel Migration: when silicone gel travels to other parts of the body from a leaking implant

Hematoma: collection of blood at the site of the surgery

Implantation: placement of breast implants in the body

Intracapsular Rupture: when the silicone gel from a ruptured silicone gel implant remains inside the scar tissue capsule necrosis: death of tissue, often including skin, which can be mutilating and difficult to repair

Reconstruction: creating a new breast form to replace a breast that has been removed, using an implant or a woman’s own tissue

Rupture: a tear or break in the breast implant envelope, which can be caused by manufacturer’s defect, daily stresses on the implant, trauma, or other causes.

Saline: salt water

Scleroderma: a chronic inflammatory disease characterized by thickening and hardening of the skin. Symptoms include difficulty swallowing, shortness of breath, joint pain, stiffness, muscle weakness and high blood pressure.

Silicone: a polymer used in synthetic rubber, adhesives, coolants, lubricants, paints and prosthetic body parts. Two kinds of silicone are used in breast implants: one for the envelope, and a gel inside the envelope.

TRAM flap: a reconstructive procedure where tissue is taken from the woman’s abdomen to form a new breast shape after a mastectomy.

Valve: a part of a saline breast implant through which the surgeon injects saline to inflate the implant