My name is Dr. Diana Zuckerman, and I am glad to speak today on behalf of the National Research Center for Women & Families. Our nonprofit organization is dedicated to improving the health and safety of adults and children.
We have several concerns about the data that have been provided to you.
First, as you can see, many of the patients have been lost to follow-up.
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Status of Post-Approval Studies |
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Study |
Allergan Follow Up |
Mentor Follow Up |
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Large Study |
2 years; 61% for silicone; 42% for saline |
3 Years; 21% for silicone; 10% for saline |
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Adjunct Study |
54% at 1-year 30% at 3-year 23% at 5-year |
36% at 1-year 24% at 3-year 16% at 5-Year |
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Status of Post-approval Studies |
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Study |
Allergan |
Mentor |
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Enrollment |
Follow Up |
Enrollment |
Follow Up |
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Core Study |
715 Patients |
65% at 10 years; Primary Aug. 66% Primary Rec. 75% |
1008 Patients |
58% at 8 years; Primary Aug. 54% Primary Recon. 67% |
Our conclusion regarding the Post-Approval Studies: Many of these follow-up rates are too low to provide useful data for augmentation patients.
Our second point is about the reported rupture rates: Since FDA reported the rupture rate in terms of the percentage of implants, it seems that this is a rate of rupture per implant, instead of per patient. Previous data shows that the price per implant is approximately twice as high as per implant.
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Mentor: Rupture Rate in MRI Cohort |
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Primary Augmentation |
Primary Reconstruction |
Revision |
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3 year |
8 year |
3 year |
8 year |
3 year |
8 year |
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By Patient |
.5% |
.8% |
4.8% |
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By Implant |
.2% |
13.6% |
.5% |
14% |
3.9% |
15.5% augment. 21.3% reconstr. |
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Allergan Rupture Rate in MR I Cohort |
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Primary Augmentation |
Primary Reconstruction |
Revision |
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4 year |
10 year |
4 year |
10 year |
4 year |
10 year |
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By Patient |
3.4% (N=166) |
20.5% (N=107) |
10.9% |
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By Implant |
1.7% (N=331) |
10.1% |
13.1% (N=182) |
27.2% |
5.7% (N=150) |
6.3% augment. 6.7% recontr. |
Why the Poor Follow-up?
One company did a much better job than other. Why is that? There is no excuse for Mentor’s poor performance because their patients and studies are very similar to Allergan’s.
Plastic surgeons tell women that implants are very safe. Does that contribute to patient’s lack of interest in participating in these studies? Or are the incentives poor? Are they receiving free doctor’s exams or money for filling out lengthy questions?
In addition, we have heard from several patients that they were “fired” by their plastic surgeons when they reported implant problems. That would obviously reduce the sample size and bias the results.
Cumulative Complications
Cumulative complication rates are decreasing in data the FDA has presented now, compared to a few years ago! That’s impossible. Cumulative complication rates should stay the same or increase from 4 years to 10 years. For example, for the Allergan data, swelling decreased from 23% to 9%.
Since come complication rates are going down, there is clearly a problem with the data. Either the company is not reporting complications correctly or the sample is changing in ways that reduce complications.
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Allergan: Cumulative Complications |
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Health Complications |
Primary Augmentation |
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3 years N=494 |
10 years N=455 |
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Reoperation |
21% |
36% |
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Removal/replacement |
8% |
21% |
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Capsular Contracture III or IV |
8% |
19% |
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Breast pain |
6% |
11% |
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Loss of Nipple Sensation |
3% |
6% |
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Seroma |
3% |
2% |
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Hematoma |
1% |
2% |
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Skin sensation changes |
2% |
2% |
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Skin Rash |
3% |
1% |
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Redness |
3% |
1% |
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Infection |
1% |
1% |
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Bruising |
9% |
.4% |
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Allergan: Cumulative Complications |
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Cosmetic Complications |
Primary Augmentation |
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3 years N=494 |
10 years N=455 |
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Swelling |
23% |
9% |
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Implant malposition |
3% |
6% |
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Scarring |
8% |
4% |
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Asymmetry |
3% |
3% |
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Ptosis (sagging) |
3% |
2% |
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Implant palpability |
2% |
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Wrinkling |
2% |
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Mentor Complications: Augmentation By Patients, Cumulative KM Risk Rates of Complication with ≥ 1% Rate through 2 and 3 years |
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Health Complications |
Augmentation N=551 |
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2-Year Rate |
3-Year Rate |
8-Year Rate |
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Reoperation |
12% |
15% |
20% |
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Nipple sensation changes |
9% |
11% |
12% |
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Capsular contracture III or IV |
8% |
8% |
11% |
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Implant removal w/ or w/o replacement |
4% |
5% |
7% |
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Breast Mass |
2% |
2% |
5% |
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Hematoma |
3% |
3% |
3% |
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Breast sensation changes |
2% |
2% |
3% |
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Breast Pain |
2% |
2% |
3% |
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Infection |
2% |
2% |
2% |
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Mentor Complications: Augmentation Cumulative KM Risk Rates of Complications through 2 and 3 yrs |
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Cosmetic Complications |
Augmentation N=551 |
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2-Year Rate |
3-Year Rate |
8-Year Rate |
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Hypertrophic scarring |
6% |
6% |
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Ptosis |
2% |
2% |
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Allergan Cumulative Complications |
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Health complications |
Primary reconstruction |
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3 years N=221 |
10 years N=98 |
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Reoperation |
46% |
72% |
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Removal/replacement |
25% |
54% |
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CC III/IV |
16% |
25% |
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Breast Pain |
6% |
7% |
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Infection |
2% |
3% |
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Seroma |
5% |
2% |
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Redness |
6% |
2% |
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Skin Rash |
3% |
2% |
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Hematoma |
2% |
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Bruising |
4% |
1% |
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Delayed wound healing |
2% |
1% |
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Allergan Cumulative Complications |
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Cosmetic Complications |
Primary Reconstruction |
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3-yrs N=221 |
10-years N=98 |
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Asymmetry |
15% |
23% |
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Wrinkling |
4% |
10% |
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Swelling |
16% |
7% |
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Implant palpability |
7% |
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Scarring |
6% |
6% |
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Implant malposition |
5% |
2% |
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Ptosis (sagging) |
1% |
0% |
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Mentor Complications: Reconstruction By patient, Cumulative KM Rates of Complications with ≥ 1% Rate through 2 and 3 years |
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Health Complication |
Reconstruction N=151 |
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2-Year Rate |
3-Year Rate |
8-Year |
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Reoperation |
25% |
26% |
39% |
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Implant removal w/ or w/o replacement |
12% |
13% |
23% |
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Capsular Contracture III/IV |
7% |
9% |
15% |
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Infection |
5% |
5% |
6% |
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Metastatic disease |
2% |
2% |
6% |
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Breast Mass |
3% |
4% |
5% |
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Seroma |
5% |
5% |
5% |
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Breast pain |
2% |
2% |
3% |
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Recurrent breast cancer |
2% |
2% |
2% |
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Implant extrusion |
1% |
1% |
1% |
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Hematoma extrusion |
2% |
2% |
? |
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Necrosis |
.4% |
1% |
? |
Mentor seems to have stopped reporting certain complication rates. For example, asymmetry and ptosis, 2 complications for reconstruction patients, are simply not reported at 8 years.
What else might Mentor have decided not to report? We don’t know.
Given these problems, it is difficult to have faith in the integrity of the Mentor data.
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Mentor Complications: Reconstruction By patient, cumulative KM Risk Rates of Complications with with ≥ 1% Rate through 2 and 3 years |
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Cosmetic Complication |
Reconstruction N=251 |
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2-Year Rate |
2-Year Rate |
8-Year Rate |
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Implant malposition/displacement |
2% |
2% |
3% |
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Asymmetry |
5% |
7% |
? |
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Ptosis |
3% |
7% |
? |
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Hypertrophic scarring |
6% |
6% |
? |
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Wrinkling |
2% |
3% |
? |
Conclusions:
Incentives are lacking for companies or surgeons to do post-market research correctly. Enforcement for the FDA is needed to provide incentives.
Data are not capturing the problems many implant patients report. This seems to be especially true for Mentor.
The FDA seems to depend on the research literature when data from the companies are lacking, but the research literature was funded by silicone and implant companies, and medical foundations with conflicts of interest. We need unbiased data, and we should not excuse the companies from providing the data that was required as a condition of approval.