Q. Should I get silicone or saline implants? Is there a price difference?

A. We believe that saline breast implants are safer than silicone gel implants.

All breast implants have risks. The most common is when the breast gets hard and painful, known as capsular contracture. Many women with implants have that problem after a few years, but it appears to be more common with silicone gel breast implants than saline implants.

Implant surgery usually costs between $5,000-8,000, including the implants and one follow-up visit. Silicone gel breast implants cost about $1,000 more than saline implants.

However, there are a lot of extra expenses that you need to be aware of.

For example, saline implants and silicone implants both have a high complication rate, and almost half the women will need additional surgery to fix implant problems within 3-4 years. Some problems are cosmetic (if the breasts look phony) and some problems are more serious (such as infections, allergic reactions, or auto-immune reactions). That additional surgery often costs $5,000 or more. That is why we suggest that women considering breast implants make sure they have at least $5,000 in their savings that they will save and not spend until they need it for their next implant surgery.

All breast implants will eventually break, but when saline implants break it is obvious (they deflate quickly) and when silicone gel breast implants break, there are often no symptoms at first. Having no symptoms might seem like an advantage, but it is really a disadvantage because silicone can leak out of the tear in the implant, and get to parts of the body where surgeons can’t remove it. Leaking silicone can cause pain and allergic or auto-immune reactions. When it is removed, the breast may be deformed.

Because of concerns about leaking silicone, the FDA warns that women with silicone gel breast implants need to get an MRI to check for leakage after 3 years, and then every other year after that. Unfortunately, breast MRIs cost about $2,000 each, sometimes more. That may seem very expensive, but it is the only accurate way to know if your implants are broken or leaking. If they are leaking, it is important to have them removed immediately.

Given the expense and the risks, why would any woman get silicone gel breast implants? There is one advantage: they feel more like a real breast. Saline implants may not feel as warm as the rest of the body in cold weather. (A figure skater told us they were painfully cold!) And, women with saline implants sometimes say that they make swooshing water noises. Most plastic surgeons prefer silicone gel implants because they tend to look and feel more natural. However, many women tell us that does not make up for the added risks and added costs.

But, it is important to know that all breast implants – saline or silicone – can cause serious health problems. They can even cause a type of cancer of the immune system, known as anaplastic large cell lymphoma (ALCL).

The bottom line: all breast implants will break, all breast implants are likely to cause complications that require additional surgery, and some women will have a bad reaction within a few weeks or months of getting their breast implants. Some complications are very serious. But some breast implants are safer than others, and since all silicone gel breast implants are more likely to leak as they get older, we believe that saline implants are safer.

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 patients, 9 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 were first sold in the U.S. in the 1960s, at a time when there was no government regulation of any medical devices, including breast implants. When a law was passed giving the FDA that authority in 1976, the agency was overwhelmed with an enormous backlog of devices that needed to be evaluated. Most devices were allowed to remain on the market until those reviews were completed, and breast implants were generally considered a much lower priority than potentially life-saving devices such as heart valves and shunts.

Scientists and physicians started expressing strong concerns about the safety of silicone breast implants in the late 1970’s, and their concerns were discussed at a 1978 FDA advisory committee meeting. By the early 1980’s, most of the risks that eventually led to the removal of silicone gel implants from the market were known or suspected, and included in a proposed rule in the Federal Register.[1]

Finally, in 1988 the FDA finalized the proposed rule. At an FDA advisory committee meeting, the warnings of earlier years had become more urgent, and a lawyer, a former Dow engineer, and other experts testified that they had seen protected court documents indicating that manufacturers were hiding safety information from FDA and the public. Several women described their own terrible experiences with implants.

The November 1988 FDA advisory panel on breast implants expressed considerable concerns about their safety. They recommended that the FDA establish a national registry of women who have breast implants.  FDA officials were opposed because of the expense, and because it could set a precedent for other implants that might cause problems for the agency. Moreover, the FDA thought a registry wasn’t viable because the American Society of Plastic and Reconstructive Surgeons did not support it.

The panel also recommended a mandatory program to inform the public of potential risks of breast implants, possibly including informed consent prior to surgery. However, it was decided that the regulations required for a mandatory program would be so strongly opposed by the plastic surgeons and manufacturers, that it was more practical to develop a voluntary program instead. At the January 1989 panel meeting, the FDA announced plans to develop a brochure and videotapes to educate women about the risks of implants prior to surgery.

The brochures and videotape were to be distributed voluntarily in the offices of plastic surgeons. The educational materials were to be developed by consensus by a diverse group of 23 individuals representing consumer organizations, manufacturers, and health professionals; each representative was given the authority to veto any decision. Because of disagreement within this group about what the materials should say, the brochures and videotapes were never completed.

By 1990, almost one million women in the U.S. had breast implants and the numbers were increasing substantially.  Congressman Ted Weiss (D-NY) chaired a Congressional oversight hearing to criticize the FDA for not yet requiring the manufacturers to evaluate the  safety of their breast implants, and the fact that no clinical trial data had been published regarding their effects on human health.

Silicone Gel-Filled Implants
In 1991, pressured by Rep. Weiss and media reports of illness and complications, the FDA finally required the manufacturers of silicone gel breast implants to submit safety studies. FDA scientists reviewing those studies pointed out that the research was inadequate — the studies included few women, the women had implants for very short periods of time, and many women were lost to follow-up. The law requires that products be proven safe and effective in order to be sold in the United States, but the FDA could not conclude whether the implants were safe or effective because of the shortcomings of the research. (There is no requirement that products be proven unsafe to keep them off the market.)

However, there was enormous pressure to keep breast implants on the market from manufacturers, plastic surgeons, and their Congressional representatives. In 1992, as a compromise, FDA allowed silicone gel breast implants to remain available as a “public health need,” but only for women participating in clinical trials, and primarily for women who had mastectomies, breast deformities, or wanted to replace a broken gel implant. Any woman who had implant surgery with silicone gel implants after 1992 was required to be regularly evaluated by her plastic surgeon as part of the study. Only a limited number of women could  receive gel implants for first-time augmentation as part of clinical trials.

In January, 2004, the FDA announced it would not approve silicone gel breast implants, because of the lack of long-term safety data. However, in April 2005, the FDA held a public meeting to once again consider approval of silicone gel breast implants, with almost the same data that they had rejected the year before. In November 2006, the FDA announced that they were approving silicone gel breast implants made by two manufacturers, Allegan and Mentor. However, the approval was on the condition that the implant makers each study 40,000 women with silicone gel implants for 10 years. In addition, the FDA stated that silicone breast implants were not approved for women under the age of 22.

Saline-Filled Breast Implants
In 2000, the FDA reviewed the safety of saline-filled breast implants for the first time. Saline implants have a silicone outer envelope and are filled with salt water. The FDA required studies of local complications, such as pain, infection, hardening, and the need for additional surgery. They did not require studies of diseases or other systemic health problems. Despite extremely high complication rates during the first three years (approximately three out of four reconstruction patients and almost half of first-time augmentation patients), the FDA approved saline implants. As part of the approval process, the FDA made information about the risks of breast implants more available. A consumer handbook and a brochure with photographs of common complications are available online here.

2011 Developments
In January 2011, the FDA announced that women with breast implants seem to be more likely to develop ALCL (anaplastic large cell lymphoma), a rare cancer of the immune system. The risk of developing ALCL is very low, but much higher in women with implants than it is in other women of the same age. ALCL is especially rare in the breast area, but for women with implants it has been found in fluid surrounding the implant and in the scar capsule, but not the breast tissue itself.  It seems that ALCL can develop in women with different types of breast implants, but the cause is unknown.[2] That is why the FDA requests  that healthcare providers notify the FDA of any cases of ALCL in women with breast implants, to determine how great the risk is compared to women without implants.

In June 2011, the FDA released the preliminary results of the long-term studies of silicone breast implants that were required as a condition of FDA approval in 2006. This included long-term follow-up of the two-year and three-year studies that were the basis of FDA approval for Mentor and Allergan silicone gel implants. It also includes each company’s study of more than 40,000 breast implant patients, that were started after the 2006 approval decision and that will be followed for 10 years.

The results indicated that complications were frequent and increased as the implants aged in the body. The most common complications were capsular contracture (hardening of the area around the implant), the need for additional surgeries to fix implant problems, and implant removal.

The FDA reported that three out of four women with Mentor implants that were enrolled in the Mentor study of 40,000 women had dropped out by the third year of the study, thus making the results meaningless. The Allergan study of augmentation patients was slightly better, with just over half of the patients still participating in the study after two years. The Allergan study of reconstruction patients was the only one of the large studies that could provide useful information, with more than 70% of those patients still enrolled after 2 years. For our summary of this report, click here. You can also read the FDA’s update on silicone breast implants (full report).

[1] The FDA’s Regulation of Silicone Breast Implants: Staff Report Prepared by the Human Resources and Intergovernmental Relations Subcommittee of the House Government Operations Committee, December 1992.

[2] Food and Drug Administration. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses.

2011 Update on Silicone Gel-Filled Breast Implants

• 2011 FDA Update on Silicone Gel Breast Implant Safety: Many Unanswered Questions (Our Analysis)

• FDA Update on the Safety of Silicone Gel-Filled Breast Implants (2011)

Selected Public Testimony at FDA Advisory Panel meeting on Breast Implants, August 2011

Margaret Dunkle

Dana Casciotti

For testimony of implant patients, read their testimony here.

FDA Materials

• Photographs of Breast Implant Complications

• FDA warning on ALCL and breast implants

Selected Public Testimony at FDA Advisory Panel meeting on Silicone Breast Implants, April 2005

Testimony of Diana Zuckerman, Ph.D.

Testimony of Ed Brent

Testimony of Dawn Miller

Testimony of Shannon Scott

Testimony of Linda MacDonald Glenn

Testimony of Audrey Sheppard

Testimony of Judy Norsigian

Testimony of Marcy Gross

Testimony of Claudia Miller, MD

Complete Transcript of FDA Advisory Panel meeting on Silicone Gel Breast Implants, April 2005

April 11, 2005 Transcript [Morning and Afternoon Public Comment] (Word)

April 11, 2005 Transcript [Evening Public Comment] (Word)

April 12, 2005 Transcript [Inamed Only] (Word)

April 13, 2005 Transcript [Mentor Only] (Word)

FDA summary of Inamed data for April 12, 2005 FDA advisory panel meeting
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed Panel Memo.pdf

FDA summary of Mentor data for April 13, 2005 FDA advisory panel meeting
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_Tab-1_fda-Mentor Panel Memo.pdf

FDA PowerPoint presentation of data on Mentor and Inamed Silicone Breast Implants, April 2005
http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4101s1.htm

Additional information about Inamed and Mentor silicone gel breast implants from the April 11-13 FDA advisory panel meeting
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1.htm

Testimony Before the FDA in 2003

Testimony of Diana Zuckerman, Ph.D.
October 15, 2003

Testimony of Anne Kasper, Ph.D.
October 14, 2003

Testimony of Sherry Henderson
October 14, 2003

Testimony of Suzy Cunningham
October 14, 2003

Testimony of Marcy Gross
October 14, 2003

Testimony of Becky S.
October 15, 2003

Testimony of Susan Pope Helman, Ph.D.

October 15, 2003

FDA PowerPoint Slides of Inamed Complications with Silicone Breast Implants, October 14-15, 2003
http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt#49

Testimony Before the FDA in 2002:

Testimony of Diana Zuckerman, Ph.D.
July, 2002

Testimony of Jae Hong Lee, MD, MPH
July, 2002

Testimony of Cynthia Pearson
July, 2002

Research by FDA Scientists

• Click here for articles by FDA Scientists

Transcript of FDA March 2000 Meeting on Saline Implants
To read the exact transcript of the 3-day FDA Advisory Panel meeting on Saline Breast Implants, click the day you want to read first. It may take some time to view or download the file:

March 1, 2000

March 2, 2000

March 3, 2000

 

Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants
This article explains why there was a massive recall of PIP breast implants in Europe but not in the U.S., and explains the strengths and weaknesses of the standards for allowing breast implants on the market in different countries. It was published in Reproductive Health Matters in December, 2012.

Cancer of the Immune System and Breast Implants: Research and Implications for Women’s Health

A study published in December 2013 raises concerns about a cancer associated with breast implants.  Our published response letter highlights the need for access to timely treatment for all patients with implants.

Research on Silicone Breast Implants and Unexplained Symptoms
A study published in 2013 sheds light on the signs and symptoms that many women with silicone implants experience, and suggests that removing the implants can improve the women’s health dramatically.

Reasonably Safe? Breast Implants and Informed Consent
This article summarizes the latest research on what is known and not known, and what patients need to know. It was published in Reproductive Health Matters in May 2010.

Adolescents, Celebrity Worship, and Cosmetic Surgery
This study shows that media portrayals of celebrities influence how adolescents feel about their looks and influence their decisions to undergo cosmetic surgery. It was published in Journal of Adolescent Health in November 2011.

Teenagers and Cosmetic Surgery: Focus on Breast Augmentation and Liposuction
This article gives physicians the information they need to make a decision about breast augmentation and liposuction for adolescents. It was published in Journal of Adolescent Health in October 2008.

What Do Women Need to Know and When Do They Need to Know It?
This summary of what women need to know before deciding whether to get breast implants was written by former president of the American Society of Plastic Surgeons and the director of FDA’s Office of Women’s Health. It was published in Plastic and Reconstructive Surgery in June 2008. It is not out of date.

Reconstructive Breast Implantation After Mastectomy
This brief article points out that a medical journal about breast implant surgery after mastectomy was misleading. It was published in Archives of Surgery.

Teenagers and Cosmetic Surgery
March, 2005

Safety and Benefits of Mentor Silicone Breast Implants From the April 2005 FDA Analysis and Meeting
This article describes the risks and benefits of Mentor silicone breast implants, based on 3-year studies provided to the FDA.

Symptoms and Complications from Inamed (Allergan) Silicone Gel Breast Implants
This article describes the risks and benefits of Allergan silicone breast implants, based on 3-year studies provided to the FDA.

Breast Implants and Mammography: What we Know and What we Don’t Know PDF version
Experts agree that breast implants interfere with mammography. This article explains why and what you can do about it.

Health Complications from Breast Implant Surgery: A Canadian Study with Implications for the U.S.
This study shows the medical problems of women with breast implants, and was conducted by the British Columbia Centre of Excellence for Women’s Health.

Where There’s Smoke, There’s Fire: The Silicone Breast Implant Controversy
This article explains why breast implants can cause joint pain and other serious health problems. It was published Journal of Rheumatology.

Silicon, Silicone, Breastfeeding, and Breast Implants
This short article explains that we still don’t know the impact of breast implants on the safety of breast milk. It was published in Pediatrics.

The European Perspective: Do Silicone Breast Implants Cause Disease?
This summary of European studies of breast implants explains why you can’t believe everything you read in medical journals.

Are Breast Implants Safe?
This summary of what is known and not known about the safety of breast implants was published in Medscape General Medicine and Plastic Surgery Nursing.

Fibromyalgia and Ruptured Silicone Gel Breast Implants
This summary of a study by scientists at the FDA explains that their research found that women with ruptured breast implants are more likely to be diagnosed with fibromyalgia and several other diseases. It was published in FDA Consumer Magazine.

Government Studies Link Breast Implants to Cancer, Lung Diseases, and Suicide
This is a summary of two articles that were written by scientists at the NIH and FDA.

Higher Rates of Lung, Brain Cancers In Patients With Breast Implants
This article summarizes research showing that women with breast implants are more likely to develop lung cancer or brain cancer than women without breast implants. It was published in Oncology Spectrums.

Do Breast Implants Cause Disease?
This article explains why the meta-analysis of studies of breast implant safety, often used as the reason why there is no reason to be concerned about breast implants, was fundamentally flawed.

Summary of Studies of Saline and Connective Tissue Diseases
This article summarizes major epidemiological studies about the connection between saline breast implants and connective tissue diseases.

Cancer risk at sites other than the breast following augmentation mammoplasty.
This is the abstract for the article by NIH and FDA researchers that found that women with breast implants are more likely to develop lung cancer or brain cancer than women without breast implants. It was published in Annals of Epidemiology.

Study of Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women
This is the abstract for the article by NIH and FDA researchers that found that women with leaking silicone gel breast implants are more likely to develop fibromyalgia than women with breast implants that are not leaking. It was published in Journal of Rheumatology.

Prevalence of Rupture of Silicone Gel Breast Implants Revealed on MR Imaging in a Population of Women in Birmingham, Alabama
This is the abstract for the article by FDA researchers and medical school faculty that found that many women with silicone gel breast implants are unaware that their implants are ruptured or leaking, and that MRIs are needed to diagnose rupture and leaking. It was published in American Journal of Roentgenology.

Study of Rupture of Silicone Gel-filled Breast Implants (MRI Component)
Sixth World Biomaterials Conference, May 2000

Study of Re-operations and Self-Reported Silicone-Gel Breast Implant Rupture (Interview Component)
Sixth World Biomaterials Conference, May 2000

What Does the Institute of Medicine Report Say About Breast Implants?
This article summarizes the findings of the Institute of Medicine report about the safety of breast implants, which has frequently been misquoted and misunderstood.

by Patricia Lieberman, Ph.D. and Diana Zuckerman, Ph.D.

How long to breast implants last? Studies by FDA scientist Dr. Lori Brown and her colleagues indicate that most women with silicone gel-filled breast implants will have at least one broken implant within 10 years.

In the first study, the FDA interviewed 907 women in the Birmingham, Alabama area who had breast implants for at least six years. In the second study, 344 women with silicone gel breast implants who had been interviewed in the first study and had not had additional surgery after getting their implants received a Magnetic Resonance Imaging (MRI) exam, to determine whether their implants were broken.

Interview Study
In the Interview Study, women with breast implants were asked if they had any additional breast surgery after getting their implants. If their implants were removed, they were asked why. Women who had surgery because they suspected their implants were ruptured were asked about what symptoms they had and whether they knew of a possible reason that their implants could have ruptured.

One-third of the women interviewed (303 of 907) reported that they had at least one operation to remove or replace a breast implant. Of the women who had additional surgeries, more than half reported that at least one of their implants was ruptured or leaking. The average time between getting implants and having additional surgery was 11.5 years.

The most common reason for additional surgery was due to complications such as pain, capsular contracture, displaced implant, infection, or a suspected rupture. Those complications occurred in 103 of the 303 women who had additional surgery. An additional 92 women had their breast implants removed because they were concerned about the safety of silicone.

Some women had additional surgery because of diseases or because they had symptoms that they or their doctors thought were due to the implant. Other women had additional surgery that was planned or staged, such as replacing tissue expanders, or to get a different size implant.

Of the 73 women who suspected their implant had ruptured, 51 suspected the rupture because they had pain in their breast, chest, or upper body. Thirty-five suspected rupture because of changes in their breast shape.

Since self-reported medical history is not always accurate, the FDA attempted to check to determine if the women’s reports were accurate. The FDA was able to obtain medical records from about half of the women who had additional surgeries, and found that the women’s reports were quite accurate. There were minor discrepancies between what the women reported and what was recorded in their medical records. Those differences could have been because researchers may have reviewed a medical record from a different surgery than the one the woman reported, the doctor might not have recorded whether an implant had ruptured, or the woman could have been mistaken that her implant was ruptured. In order to eliminate those biases, the FDA performed a second study, using MRIs. The MRI Study, described below, showed even higher rates of implant rupture than the Interview Study.

MRI Study
The FDA recruited women from the Interview Study to have a Magnetic Resonance Imaging (MRI) exam to determine if their implants were ruptured. The study looked at 344 women who had 687 silicone gel-filled breast implants and who did not suspect that their implants were broken. The average time a woman had implants was about 17 years. Three radiologists looked at each of the MRIs and determined if the implants were intact, suspicious for rupture, or ruptured.

Since the study excluded the one-third of the women in the Interview Study who already had their implants removed due to breakage or other complications, the actual rupture rate is even higher than this study reports. More than two-thirds (69 percent) of the women who had not previously had surgery were found to have at least one ruptured implant in the MRI Study.

Almost half (48 percent) of the women who had implants for only six to 10 years had at least one ruptured implant. Even more, 79 percent, of the women who had implants for 11-15 years had at least one ruptured implant, and similarly, 72 percent of women who had implants for 16 to 20 years had at least one ruptured implant. The rupture rate was lower, approximately one in three, among the few women who had implants for 21 years or more. This is probably because implants made prior to 1975 were made with thicker envelopes and thicker silicone gel.

Of particular concern was whether the silicone migrated outside of the scar tissue that surrounds the implant. Migrating silicone is almost impossible to surgically remove, and efforts to remove it can result in surgery resembling a mastectomy. The findings were bad news for patients with gel implants: the radiologists agreed that more than one in five women (21 percent) had silicone gel that had migrated, and could therefore potentially migrate to essential organs.

There were several factors that affected the likelihood that an implant had ruptured, such as the age of the implant, which manufacturer made the implant, and whether the implant was put above or beneath the chest muscle. Unfortunately, most of these findings have not yet been reported, and the study is not yet published.

Implications for Patients and Women Considering Gel Implants

• The results of this study show that most women with silicone gel implants will have a broken implant within 10 years but they are unlikely to detect it unless they get an MRI.

• The study also indicates that estimates of rupture that are based on the women who have surgery to remove broken implants will grossly underestimate the problem. As a result of the many “silent ruptures,” implant patients and their surgeons have been unaware that most women will require repeated surgeries even if they do not have physical complaints about their implants.

• Even more worrisome, gel was migrating outside the scar capsule for more than one in every five women who were unaware that their implants were broken. This puts these women at risk for losing at least some of their own breast tissue when the implants are removed. In the most extreme cases, some of these women will need a mastectomy to remove the silicone, and the silicone could also migrate to the lungs or other vital organs.

By Rachael Flynn, MPH and Diana Zuckerman, Ph.D.

The first study to systematically evaluate the health of women with ruptured breast implants has raised serious concerns about silicone implants. A team of scientists led by Dr. Lori Brown of the Food and Drug Administration (FDA) reported that women whose ruptured breast implants leaked silicone outside the scar tissue surrounding the implant were significantly more likely to have been diagnosed with fibromyalgia (a painful soft-tissue disease), pulmonary fibrosis, and connective-tissue diseases such as dermatomyositis.

Magnetic resonance imaging (MRI) was used to examine the status of the breast implants of the women participating in the study. Based on the implant’s condition, researchers assigned cases to three groups: intact, ruptured, or indeterminable. (Those implants that appeared ruptured but were not able to be confirmed, were classified as indeterminable.) Radiologists also determined which ruptured cases had silicone that migrated outside of the scar capsule that surrounds the breast implant. A majority of the women had at least one ruptured implant, even though they were often unaware of that condition. Also, 21% had silicone that migrated outside of the breast area from at least one broken and leaking implant.

Women with ruptured implants where the silicone had traveled outside of the scar tissue were compared to women in the intact and indeterminable groups; investigators found an increase in fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, pulmonary fibrosis, eosinophilic fascitis, and polymyalgia. The significant association with fibromyalgia remained even after controlling for patient’s age, implant age, location, and manufacturer. Therefore, once the silicone from a broken implant migrates outside of the breast area, the woman’s risk for these serious diseases increases considerably.

This study raises serious concerns for women with ruptured implants, because it indicates that women who are unaware that an implant is ruptured and leaking could be at increased risk for health problems due to their exposure to silicone.

The study evaluated 344 women with silicone gel implants who had not sought to have their implants removed, and who were contacted from a list of patients from two medical practices. They were selected from a sample of 907 augmentation patients for a study designed to determine the percent of implants that are ruptured in the population of women who had not sought treatment for problems with their implants; 70 women who had their implants removed were excluded from the original sample of women, as were women with saline implants. Eighty-one percent of the women who were invited to participate in the study accepted.

This study is the third to be published in May 2001 with findings that indicate potentially serious health risks for women with breast implants. The other studies, conducted by scientists at the National Cancer Institute, found a 21% overall increased risk of cancer for women with implants and a 100% or more increase in mortality from brain tumors, lung cancer, other respiratory diseases, and suicide.

FDA Study:
Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women. The Journal of Rheumatology 2001;28:996-1003.

NCI Studies:
Brinton, LA, Lubin, JH, Burich, MC, Colton, T, and Hoover, RN. Mortality Among Augmentation Mammoplasty Patients, Epidemiology 2001; 12: 321-326.

Brinton, LA, Lubin, JH, Burich, MC, Colton, T, Brown, SL, and Hoover, RN. Cancer Risk at Sites Other Than the Breast Following Augmentation Mammoplasty. Annals of Epidemiology 2001;11: 248-256.

By Diana Zuckerman, Ph.D. and Rachael Flynn, MPH

Two major new studies raise questions about the long-term safety of breast implants. A team of researchers led by Louise Brinton, Ph.D., of the National Cancer Institute (NCI) published these studies on the long-term health effects of breast implants. One of the studies found that women with breast implants are more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients. The other study found a 21% overall increased risk of cancer for women with implants, compared to women of the same age in the general population.

These studies are the first to look at all types of cancer and all causes of death among breast implant patients. While the authors were not able to determine whether implants caused these illnesses, the results show a doubling of brain cancer and a tripling of lung cancer, emphysema, and pneumonia for women with implants. Even though these findings were described as “unexpected,” they are consistent with previous research that shows brain abnormalities and lung problems related to breast implants. There was also a four-fold increase in suicide for breast implant patients, which seems to contradict the manufacturers’ assertion that implants improve a woman’s feeling of self-worth.

Why are these results so different from widely reported claims that breast implants do not cause any diseases? One reason may be that the women included in the studies all had implants for at least eight years. Previous research included women who had only had breast implants for a year or two, or even a few months. Therefore, these new studies are the first examine the long-term health effects of breast implants. Unfortunately, even though diseases may take much longer than 8 years to develop and be diagnosed, the findings from these well-designed studies indicate a potentially serious risk for the health of women with breast implants.

Another possible reason for this difference is that plastic surgeons and the implant manufacturers helped design and fund much of the previous research on implants; these groups have a tremendous financial stake — billions of dollars — in the outcome. Perhaps that is why so many previous studies focused on just a few, rare diseases, rather than a more comprehensive evaluation of the women’s health.

Study Design
The comprehensive studies started with the same group of nearly 13,500 women from 6 different geographical regions in the U.S. Information was gathered from patient questionnaires and medical records. Both studies compared women with implants to women who underwent other forms of plastic surgery as well as the general population of women the same age. In general women with implants were healthier than women in the general population, but less healthy than other plastic surgery patients. The latter is a more appropriate comparison because all plastic surgery patients tend to be more affluent than the general population, and more affluent women tend to live longer.

More Research Needed
More independent research, funded by the federal government, is needed to determine why breast implants are linked to cancer and other fatal diseases in these new studies. In addition, these two studies need to be continued to see whether the results change as the women (and their implants) age. Since approximately 2 million women in the United States already have breast implants and another 300,000 are planning on getting them this year, research on the long-term health effects is long overdue.

The new studies are:
Brinton, LA, Lubin, JH, Burich, MC, Colton, T, and Hoover, RN. Mortality Among Augmentation Mammoplasty Patients, Epidemiology 2001; 12: 321-326.

Brinton, LA, Lubin, JH, Burich, MC, Colton, T, Brown, SL, and Hoover, RN. Cancer Risk at Sites Other Than the Breast Following Augmentation Mammoplasty. Annals of Epidemiology 2001;11: 248-256.

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Updated February 2008

Complications of Saline Breast Implants:
What You Should Know Before You Decide on Reconstruction

By Elizabeth Nagelin-Anderson, M.A. and Diana Zuckerman, Ph.D.

How risky are breast implants? This is a controversial question, but implant manufacturers have done research showing that local complications, including pain, rupture, and the need for additional surgery, are very common within the first three years.

The FDA required breast implant manufacturers Mentor Corporation and Inamed Aesthetics (formerly called McGhan) to conduct research on the complications of saline breast implants for breast reconstruction and breast augmentation patients. The purpose of this research was to provide women with information so that they can make a more informed decision about whether or not they want saline breast implants. This information is supposed to be made available by plastic surgeons to all patients before they make their decision. The studies did not include diseases or conditions such as cancer, lupus, or fibromyalgia.

This issue brief is based on the FDA’s analyses of data collected by Mentor Corporation and Inamed Aesthetics. It is based on research, not opinion. The 3-year data were analyzed by the FDA in 2000 and the 5-year data were analyzed in 2002. This fact sheet is only about reconstruction patients.

Mentor Saline Implants
Mentor conducted a 5-year study on reconstruction patients. Unfortunately, so many women (almost 60%) dropped out of the study before the five years were completed, that the information is not reliable. For that reason, we are only providing the information collected during the first 3 years after getting implants, which included 78% of the patients.

Important Points from the Mentor Data

• Most women can expect at least one complication within the first 3 years.
• 40% of reconstruction patients can expect to have additional surgery within the first 3 years.

Mentor Reconstruction Patients 3-Year Complication Rate
Reconstruction patients experienced the following problems within the first 3 years of receiving their implants:

40%	Needed another operation
30%	Capsular contracture (hardening of breast)
28%	Asymmetry (breasts look different from each other)
27%	Implant removal
20%	Wrinkled appearance of breast
17%	Breast pain
9%	Infection
9%	Implant leaks/deflates
8%	Irritation/inflammation
6%	Delayed wound healing
6%	Seroma (watery portion of blood collects around implant or incision)
5%	Scarring complications
2%	Extrusion (implant comes through the skin)
2%	Necrosis (death of skin or tissue)
1%	Hematoma (blood collects around implant)
1%	Position of implant changes

Loss of nipple sensation is not listed since nipples are removed during mastectomy.

Only 78% of the reconstruction patients who originally enrolled in the study completed all 3 years. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher.

Inamed Saline Implants
Inamed, formerly called McGhan, conducted a 5-year study on breast reconstruction patients. They collected information at the 3-year point from 71% of the reconstruction patients who originally enrolled in the study.

At the 5-year point they collected information from 57% of the reconstruction patients. This is a problem, since no information is available for 43% of the patients. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher, and the 3-year data are more reliable than the 5-year data.

Important Points from the Inamed Data

• Most women can expect to experience at least one complication at some point within 5 years after implant surgery.

• 40% of reconstruction patients can expect to have additional surgery within the first 5 years.

Inamed Reconstruction Patients 3-Year and 5-Year Complication Rates
Reconstruction patients experienced the following complications during the first three years and first five years after surgery.

3 Year	5 Year
39%	45%	Needed another operation
33%	39%	Asymmetry (breasts look different from each other)
25%	36%	Capsular contracture (hardening of breast)
23%	28%	Implant replacement/removal – any reason
20%	27%	Implant can be felt or seen
23%	25%	Wrinkled appearance of breast
15%	18%	Breast pain
12%	17%	Implant is in a bad position
6%	8%	Implants leaks/deflates
7%	7%	Irritation/inflammation
6%	6%	Intense skin sensation
6%	6%	Scarring complications
5%	6%	Infection
5%	5%	Calcium deposits form around implant
4%	4%	Seroma (watery portion of blood collects around implant or incision)
4%	4%	Skin/tissue necrosis (death of skin or tissue)
3%	3%	Delayed wound healing
3%	3%	Implant extrusion (implant comes through the skin)
3%	3%	Skin Rash
1%	1%	Hematoma (blood collects around the implant)

Loss of nipple sensation is not listed since nipples are removed during mastectomy.

Most complications for Inamed patients through the first 5 years are similar to those reported after the first 3 years. Since it is well known that some complications, such as rupture and capsular contracture, increase over time, women with complications were apparently more likely to leave the study than those who continued. Some of these women have left their plastic surgeons and could not be contacted.

References:

http://www.fda.gov/cdrh/breastimplants/labeling/mentor_patient_labeling_5900.html#_Toc20548932

http://www.fda.gov/cdrh/breastimplants/labeling/Inamed_patient_labeling_5900.html#_Toc20904704