Breast Implants- Impact of FDA Reapproval of Silicone Implants

A Survey of Fifty-two Plastic Surgeons

February 2007

STUDY DESCRIPTION

OBJECTIVES

To determine the impact of the FDA’s re-approval of silicone implants on the markets for breast augmentation and reconstruction procedures.  Additionally to:

• Identify the current and anticipated future product use for breast augmentation and reconstruction procedures.
• Examine the impact of the FDA’s re-approval of silicone implants on patient volume, patient types, and prices.
• Evaluate concerns plastic surgeons and their patients have over the long-term safety of and clinical trial requirements for silicone breast implants.
• Predict future use of dermal tissue products in breast reconstruction procedures.

Companies and Products Mentioned in This Report 

Inclusion Criteria and Respondent Demoigraphics

Key Findings

Breast Implant Use

• Plastic surgeons select Mentor saline implants most frequently for breast augmentation procedures for both 2006 and 2007.

• Anticipated changes in the number of patients using each type of implant for augmentation in the year 2007 versus 2006.
• Mentor silicone: Increase by 19 patients (17 to 34)
• Mentor saline: Decrease by 17 patients (64 to 47)
• Inamed silicone: Increase by 15 patients (14 to 29)
• Inamed saline: Decrease by 13 patients (44 to 31)

• Plastic surgeons select Mentor silicone implants most frequently for breast reconstruction procedures for both 2006 and 2007.

• Anticipated changes in the number of patients using each type of implant for reconstruction in the year 2007 versus 2006.
• Mentor silicone: Increase by 1 patient (19 to 20)
• Mentor saline: Decrease by 6 patients (13 to 7)
• Inamed silicone: Increase by 8 patients (13 to 21)
• Inamed saline: Decrease by 3 patients (18 to 15)

• 73% of respondents believe FDA reapproval of silicone implants will cause a 23% mean increase in the number of breast augmentation procedures in 2007 versus 2006.
• A mean of 58% of breast augmentation patients have chosen saline implants versus 42% who have chosen silicone implants over the last 60 days.
• 8% of the plastic surgeons currently have a waiting list for silicone implants.

• Mean number of patients on the waiting list: 21.
• 3 of the 4 respondents with a waiting list indicate these patients will receive silicone implants within 1 to 3 months.

• Respondents anticipate the percentage of augmentation patients choosing silicone over saline will increase over the next 2 years due to the FDA’s reapproval:

• 6 months from now: 58% saline versus 42% silicone
• 12 months from now: 52% saline versus 48% silicone
• 2 years from now: 43% saline versus 57% silicone

• The plastic surgeons indicate that about 58% of their breast augmentation patients receive implants for the first time and 42% replace old implants.

• Over the next 2 years, they anticipate that about three-quarters of their breast augmentation patients who request silicone implants will be new patients while one-quarter will be patients replacing saline implants.

Price Effects

• Respondents estimate cost to remain relatively the same following FDA reapproval of silicone implants with silicone implants around $1,100 and saline implants around $650

Breast Implant Patient Demographics

• Most important criteria for choosing between silicone and saline for augmentation:

• Appearance (4.5 out of 5)
• Feel (4.4 out of 5)
• Long-term safety (4.1 out of 5)

Concerns Regarding FDA Approval

• Level of concern over long-term safety of silicone implants (1=Not at all concerned and 5=Very concerned).

• Physicians: 2.5 out of 5
• Patients: 3.5 out of 5
• Almost two-thirds of the plastic surgeons believe that patients’ concerns over long-term safety has affected their decision to undergo breast augmentation surgery.

• The plastic surgeons rate themselves as somewhat concerned (3.2 out of 5) about the clinical trial requirements associated with silicone breast implants.
• 75% of the respondents have participated in a clinical trial for silicone implants.

• Many indicate that these trials were time consuming and involved a lot of paperwork.
• 11 of the respondents participated in a Mentor trial and 4 participated in an Inamed trial.

• Respondents believe the added cost of the clinical trials is about twice as much for physicians ($668) as it is for patients ($324).
• 83% of the plastic surgeons do not believe clinical trial requirements will impact the number of breast augmentation procedures performed in 2007 versus 2006.

Human Cellular Tissue Matrix

• Approximately two-thirds of the plastic surgeons anticipate using dermal tissue products for breast reconstruction procedures.

• Anticipated percentage of breast reconstruction procedures in which dermal products will be used:
• 2007: 34% of procedures
• 2008: 39% of procedures

• A large majority (around 90%) of respondents who anticipate using dermal tissue products for breast reconstruction anticipate using AlloDerm in both 2007 and 2008.

• Patients with thin skin and poor muscle or implant coverage are the most frequently mentioned situation in which the plastic surgeons anticipate using AlloDerm.
• Many anticipate using it for tissue expander reconstructions and others for reconstruction of the inframammary fold.
• Only 3% of the respondents anticipate using NeoForm in 2008 and none in 2007.
• Other products they anticipate using are Dermamatrix and Surgimend.

quantitative survey detailed findings by question

SECTION ONE: Breast Implant Use

Question 1.

Please estimate the percentage and number of breast augmentation patients in 2006 that received each of the following types of implants.

Question 3.

In 2007, please estimate the percentage and number of breast augmentation patients you anticipate will receive each of the following types of implants.

Question 2.

Please estimate the percentage and number of breast reconstruction patients in 2006 that received each of the following types of implants.

Question 4.

In 2007, please estimate the percentage and number of breast reconstruction patients you anticipate will receive each of the following types of implants.

Question 5.

In your opinion, how will the FDA’s re-approval of silicone implants affect the number of breast augmentation procedures performed in 2007 compared with 2006?

Question 6.

Within the last 60 days, please estimate the percentage of your breast augmentation patients who have selected silicone versus saline breast implants.

Question 7.

Do you currently have a waiting list for silicone breast implants?

Question 8.

Currently, how many patients are on your waiting list for silicone implants?

Question 9.

Please estimate in how many months these patients will be treated?

Question 10.

Given the recent FDA re-approval of silicone breast implants, please estimate the percentage of your future breast augmentation patients you expect to select each type of implant at each of the following time periods

Question 11.

Historically, please estimate the percentage of your breast augmentation patients who are new patients and those who are replacing older implants.

Question 12.

For your future breast augmentation patients expected to select silicone implants, please estimate the percentage of patients who will be new patients versus patients replacing their saline implants at each of the following time periods.

SECTIOn two: Price Effects

Question 13.

Please estimate the current price per implant of silicone and saline breast implants.

Question 14.

To the best of your ability, please estimate the price per implant of silicone and saline breast implants at each of the following time periods.

section three: Breast Implant Patient Demographics

Question 15.

On a scale from 1 to 5, please rate the importance of each of the following criteria when deciding whether to use silicone or saline breast implants for your breast augmentation patients. “1” indicating “Not at all important” and “5” indicating “Very important.”

Section Four: Concerns Regarding FDA Approval

Question 16.

Please rate on a scale of 1 to 5 your level of concern about the long-term safety of silicone breast implants, with “1” indicating “Not at all concerned” and “5” indicating “Very concerned.” 

Question 17.

Please rate on a scale of 1 to 5 your patients’ level of concern about the long-term safety of silicone breast implants, with “1” indicating “Not at all concerned” and “5” indicating “Very concerned.”

Question 18.

Have concerns about the long-term safety of silicone breast implants affected your patients’ decisions to undergo breast augmentation surgery?

Question 19.

Please rate on a scale of 1 to 5 your level of concern about the clinical trial requirements associated with silicone breast implants, with “1” indicating “Not at all concerned” and “5” indicating “Very concerned.” 

Question 20.

Have you participated in a clinical trial for silicone breast implants?

Question 21.

Please comment on your participation in the clinical trial.

Question 22.

Please estimate the added cost of participating in the trial will be for you and for your patients?

Question 23.

In your opinion, how will the clinical trial requirements associated with silicone implants affect the number of breast augmentation procedures performed in 2007 compared with 2006?

Section Five: Human Cellular Tissue Matrix

Question 24.

Do you anticipate using dermal tissue products for breast reconstruction procedures?

Question 25.

Please estimate the percentage of breast reconstruction procedures you anticipate performing in 2007 and 2008 for which dermal tissue products will be used.

Question 26.

Of the <answer from Q25_1> percent of future reconstruction procedures for which you plan to use dermal tissue products, please estimate the proportion that will be each of the following products.

Question 27.

Please comment on the patients and situations for which you will use LifeCell’s AlloDerm?

Question 28.

Please comment on the patients and situations for which you will use Mentor’s NeoForm?