Diana Zuckerman, PhD, October 6, 2011
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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 | ||
| Enrollment | Follow Up | Enrollment | Follow Up | |
| Core Study | 715 Patients | 65% at 10 years;Primary Aug. 66%Primary Rec. 75% | 1008 Patients | 58% at 8 yearsPrimary Aug. 54%Primary Recon. 67% |
Conclusion of Post-Approval Studies: Many of these rates are too low to provide useful data for augmentation patients.
Rupture Rate: The FDA mistakenly reported the rupture rate per implant as if it were per patient. Previous data shows that the price per implant is approximately twice as high as per implant.
| Mentor: Rupture Rate in MRI Cohort | ||||||
| Primary Augmentation | Primary Reconstruction | Revision | ||||
| 3 year | 8 year | 3 year | 8 year | 3 year | 8 year | |
| By Patient | .5% | .8% | 4.8% | |||
| By Implant |
.2% | 13.6% | .5% | 14% | 3.9% | 15.5% augment. 21.3% reconstr. |
| AllerganRupture Rate in MRI Cohort | ||||||
| Primary Augmentation | Primary Reconstruction | Revision | ||||
| 4 year | 10 year | 4 year | 10 year | 4 year | 10 year | |
| By Patient | 3.4%(N=166) | 20.5%(N=107) | 10.9% | |||
| By Implant | 1.7%(N=331) | 10.1% | 13.1%(N=182) | 27.2% | 5.7%(N=150) | 6.3% aug6.7% rec |
Why the Poor Follow-up?
Once company did a much better job than other. There is no excuse for Mentor’s poor performance because their patients and studies are like Allergan’s.
Plastic surgeons tell women that complaints are so safe that the women aren’t concerned about follow-up. Does the contribute to patient’s lack of interest in participating in these studies? Or are incentives poor? In addition, women are being “fired” by their plastic surgeons.
Cumulative Complications
Cumulative complication rates are decreasing in data the FDA has presented now compared to a few years ago! That’s impossible. They should stay the same or increase from 4 years to 10 years. (Allergan: swelling decreased from 23% to 9%)
Since come complication rates are going down there is a problem with the data. Either the company is not reporting complications correctly or the sample is changing in ways that reduce complications.
| Allergan:Cumulative Complications | ||
| Health Complications | Primary Augmentation | |
| 3 yearsN=494 | 10 yearsN=455 | |
| Reoperation | 21% | 36% |
| Removal/replacement | 8% | 21% |
| Capsular Contracture III or IV | 8% | 19% |
| Breast pain | 6% | 11% |
| Loss of Nipple Sensation | 3% | 6% |
| Seroma | 3% | 2% |
| Hematoma | 1% | 2% |
| Skin sensation changes | 2% | 2% |
| Skin Rash | 3% | 1% |
| Redness | 3% | 1% |
| Infection | 1% | 1% |
| Bruising | 9% | .4% |
| Allergan: Cumulative Complications | ||
| Cosmetic Complications | Primary Augmentation | |
| 3 yearsN=494 | 10 yearsN=455 | |
| Swelling | 23% | 9% |
| Implant malposition | 3% | 6% |
| Scarring | 8% | 4% |
| Asymmetry | 3% | 3% |
| Ptosis (sagging) | 3% | 2% |
| Implant palpability | 2% | |
| Wrinkling | 2% | |
| MentorComplications: 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 | ||
| 2-Year Rate | 3-Year Rate | 8-Year Rate | |
| Reoperation | 12% | 15% | 20% |
| Nipple sensation changes | 9% | 11% | 12% |
| Capsular contracture III or IV | 8% | 8% | 11% |
| Implant removal w/ or w/o replacement | 4% | 5% | 7% |
| Breast Mass | 2% | 2% | 5% |
| Hematoma | 3% | 3% | 3% |
| Breast sensation changes | 2% | 2% | 3% |
| Breast Pain | 2% | 2% | 3% |
| Infection | 2% | 2% | 2% |
| MentorComplications: Augmentation
Cumulative KM Risk Rates of Complications through 2 and 3 yrs |
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| Cosmetic Complications | Augmentation N=551 | ||
| 2-Year Rate | 3-Year Rate | 8-Year Rate | |
| Hypertrophic scarring | 6% | 6% | |
| Ptosis | 2% | 2% | |
| AllerganCumulative Complications | ||
| Health complications | Primary reconstruction | |
| 3 yearsN=221 | 10 yearsN=98 | |
| Reoperation | 46% | 72% |
| Removal/replacement | 25% | 54% |
| CC III/IV | 16% | 25% |
| Breast Pain | 6% | 7% |
| Infection | 2% | 3% |
| Seroma | 5% | 2% |
| Redness | 6% | 2% |
| Skin Rash | 3% | 2% |
| Hematoma | 2% | |
| Bruising | 4% | 1% |
| Delayed wound healing | 2% | 1% |
| AllerganCumulative Complications | ||
| Cosmetic Complications | Primary Reconstruction | |
| 3-yrsN=221 | 10-yearsN=98 | |
| Asymmetry | 15% | 23% |
| Wrinkling | 4% | 10% |
| Swelling | 16% | 7% |
| Implant palpability | 7% | |
| Scarring | 6% | 6% |
| Implant malposition | 5% | 2% |
| Ptosis (sagging) | 1% | 0% |
| MentorComplications: Reconstruction
By patient, Cumulative KM Rates of Complications with ≥ 1% Rate through 2 and 3 years |
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| Health Complication | ReconstructionN=151 | ||
| 2-Year Rate | 3-Year Rate | 8-Year | |
| Reoperation | 25% | 26% | 39% |
| Implant removal w/ or w/o replacement | 12% | 13% | 23% |
| Capsular Contracture III/IV | 7% | 9% | 15% |
| Infection | 5% | 5% | 6% |
| Metastatic disease | 2% | 2% | 6% |
| Breast Mass | 3% | 4% | 5% |
| Seroma | 5% | 5% | 5% |
| Breast pain | 2% | 2% | 3% |
| Recurrent breast cancer | 2% | 2% | 2% |
| Implant extrusion | 1% | 1% | 1% |
| Hematoma extrusion | 2% | 2% | ? |
| Necrosis | .4% | 1% | ? |
Cumulative Complications
Mentor seems to have stopped reporting certain complication rates. For example, asymmetry. 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?
Given these problems, it is difficult to have faith in the integrity of the Mentor data.
| MentorComplications: Reconstruction
By patient, cumulative KM Risk Rates of Complications with with ≥ 1% Rate through 2 and 3 years |
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| Cosmetic Complication | ReconstructionN=251 | ||
| 2-Year Rate | 2-Year Rate | 8-Year Rate | |
| Implant malposition/displacement | 2% | 2% | 3% |
| Asymmetry | 5% | 7% | ? |
| Ptosis | 3% | 7% | ? |
| Hypertrophic scarring | 6% | 6% | ? |
| Wrinkling | 2% | 3% | ? |
Conclusions:
Incentives are lacking for companies or surgeons to do post-market research correctly. Enforcement is needed to provide incentives.
Data are not capturing the problems many implant patients report-especially Mentor.
Literature is funded by silicone and implant companies, and medical foundations with conflicts of interest.