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Public Citizen Calls for Criminal Investigation of Breast Implant Manufacturer for Withholding Safety Data from FDA (HRG Publication #1790)

Public Citizen's letter to the FDA written by Sidney M. Wolfe, MD.

Whistleblower's letter to the FDA highlighting dangers associated with silicone gel implants.

Public Citizen's Letter to the FDA

October 12, 2006

Andrew von Eschenbach, M.D., Acting Commissioner
U.S. Food and Drug Administration
Food and Drug Administration
5600 Fishers Lane 
Rockville,  MD 20857 

Dear Dr. von Eschenbach:

I have recently obtained a copy (below) of a June 22, 2006 letter sent to the FDA by a former senior scientist from Mentor—one of the two companies seeking FDA approval of silicone gel breast implants—accusing the company of withholding from the FDA important new safety information concerning dangerous physical and chemical properties of their implants. Prior to sending the letter, the scientist had raised all of the serious concerns mentioned in the letter within the company; he had urged Mentor to submit the withheld data, but they had refused. The scientist sent the information to the FDA only after his employment was terminated after 15 years with the company.

Several weeks ago, the former Mentor scientist was called by the FDA staff member to whom the letter was sent. The scientist was told that because:

(1)  the withheld test data demonstrating dangers of the implants referred to in the letter were not required in FDA’s request to Mentor (and Inamed, the other breast implant manufacturer) for more studies (referred to as the “deficiency response”); and (2) since the submitted data from both Mentor and Inamed (the other silicone gel breast implant manufacturer) were similar, that he had no other comment on the new information, implying that the agency would take no action.

This new information is compelling enough to warrant a reassessment of FDA’s position. At the very least it should clearly stop any FDA final approval of either device until the withheld data has been submitted, evaluated by the FDA staff, and made available to the public. This new evidence that information has been illegally withheld from the FDA should prompt a new criminal investigation into the Mentor’s failure to promptly send the agency all new information bearing on the safety of silicone gel implants.

In discussions with the scientist, he has explained to me the details and significance of the information. This is summarized below, under five subheadings that correspond to the five points made in the letter to the FDA:

Tests/data concerning gel leakage, composition

1. Diffusion Testing Validation: The gel bleed (diffusion out of the implant and into the body) chemical test data submitted to the FDA is invalid and has been fraudulently represented. A new procedure to correct this problem was successfully tested but the data from this more valid method was never submitted to the FDA. The importance of this is that the submitted data might understate the amount of low molecular weight siloxanes (the more toxic component of silicone gel) that is seeping out from the implant into the body.
2. Explant Semivolatile Extractable Testing: In tests of explanted silicone gel implants, the company found that there were very large amounts of the above-mentioned low molecular weight siloxanes compared to the amounts in devices that had not yet been implanted, implying that the larger molecular weight siloxanes were continually being degraded in the body to low molecular weight siloxanes. This suggests that a continual degradation of higher molecular weight gel to lower molecular weight siloxanes and bleeding of this may subject women to a constant source of the more dangerous low molecular weight siloxanes. These data were not submitted to the FDA.

   Tests related to mechanical properties of the implant

3. Explant Mechanical Testing: The company found a significant decrease in some of the mechanical properties of explanted devices in comparison to unimplanted control devices from the same manufacturing lot. In their submission to the FDA, however, these comparisons with unimplanted devices were not explicitly made, thus obscuring as much as a 50% decrease in some of these mechanical properties. This magnitude of weakening of the implant shell is extremely relevant to the issue of implant rupture.
4. Device Projection Fatigue Testing: Device projection refers to the distance from the front of the implant to the back (the anterior-posterior distance). A Mentor investigation of the relationship between device projection and fatigue lifetime (the time until the implant ruptures) found an inverse relationship, i.e., as the device projection increased, the estimated lifetime of the device decreased. This information was also not sent to the FDA.

   More toxic form of platinum in the implant shell

5. Platinum Valence: As noted in the letter, Mentor studies showed that in the silicone rubber envelope of the implant, Platinum existed in the +2 oxidation state (Pt (II). This previously unknown finding is of potential importance since this oxidation state is thought to be more toxic than the Pt (0) oxidation state of the metal. Again, this information was not sent to the FDA.

In summary, this former Mentor scientist has made the FDA aware of previously undisclosed information based on company files. These include considerable test data showing safety problems with silicone gel breast implants. Although some of these studies were not “required “ to be done in the Guidance among the studies the FDA asked Mentor to do, their results directly address important issues of safety that are of relevance and concern. The fact that they were done and that they found some serious problems with the safety of the implants is reason enough for the FDA to take them into account and demand that Mentor provide the actual data from the studies.

As mentioned above, no approval decision on either the Mentor or Inamed implants can be made until the FDA is in possession of and has evaluated these new studies. Unless the FDA opens a criminal investigation into Mentor’s failure to submit the studies, it will encourage Mentor and other device manufacturers to selectively send the agency only those studies that put their products in the most favorable light. Please note that in his letter to the FDA, the former employee identified the specific Mentor staff files containing the withheld information.

I look forward to a prompt response concerning this serious matter.

Sincerely,

Sidney M. Wolfe, MD
Director, Public Citizen’s Health Research Group

Letter to the FDA from a Mentor Employee

June 22, 2006

Food and Drug Administration
Center for Devices and Radiologic Health
Mr. Carl DeMarco, R.Ph., J.D.
Integrity Officer
Office of Device Evaluation
301 594 2022 134

Round Profile Gel Mammary Implants
Premarket Approval Application
Preclinical Chemical and Mechanical Testing
Mentor Corporation
201 Mentor Drive
Santa Barbara, CA 93111
Research and Development Laboratory Services Document Control Program

1) Diffusion Testing Validation

The gel bleed or diffusion testing for low molecular weight siloxanes representing Round Gel Mammary Implants is invalid. I discovered this discrepancy shortly after the submission of the first PMA deficiency response (August 2004) upon thorough review of the raw data and results. Xxxxxxxxx performed the testing and failed to inform me of these difficulties. Consequently this information was concealed from me until I confronted her with the issues. Had I been aware of the problems I would never have submitted the work to the FDA since it could not be defended. The two major issues with the test method were the signal-to-background ratios (~0.1) and now recovery for the duration of the study. This was communicated with upper management Xxxxxxxxxxxxxxxxxxxxxx and also shared with other senior management personnel. I was eliminated from any further participation with FDA to discuss and provide an appropriate interpretation of the results. Subsequently the results were defended by Xxxxxxxxxxxxxxxxxxxx and no acknowledgement of the inability to validate the submission data was communicated. Eventually alternate methodology was developed, reviewed and approved by me (~1 year) however this also was not communicated since it would directly contradict previous submission data. The report for the new method is located in 1 of 2 file cabinets in Document Control labeled Gel Mammary Implants. This report outlines the new and distinct test method that was developed and validated. It describes the manner in which to present data using statistical analysis and includes recovery results for the 90 day duration of the diffusion experiment. The previous method could not be validated for recovery since after approximately 7 days the target analytes disappeared. Accordingly comparison of the old method results to the new method results will reveal the the former yielded erroneous data. Work ultimately returned to my oversight upon the reassignment of Xxxxxxxxxxxx. However no further communication was permitted with FDA during the RPG PMA review..

2) Explant Semivolatile Extractable Testing

Chemical testing of explanted implants was undertaken during the preparation of the deficiency response directed by Xxxxxxxxxxx. Again I was eliminated from participation due to my objection of the preliminary experimental design. Results showed that explanted device gel exhibited exceedingly large quantities of low molecular weight siloxanes compared to devices that had not been implanted. This report is located in 1 of 2 file cabinets in Document Control labeled Gel Mammary Implants. It was added as an addendum to another project conducted at SwRI (Southwest Research Institute) pertaining to total platinum analysis of shell and filler components in gel mammary implants. The immediate interpretation was in vivo biodegradation. Xxxxxxxxxxxxx responsibility for damage control. These results were not submitted to FDA in the deficiency response. No further studies have been undertaken to address the issues. Xxxxxxxxx were reassigned. I have separated from Mentor. Project status unknown.

3) Explant Mechanical Testing

Mechanical testing of explanted implants was undertaken during the preparation of the deficiency response directed by Xxxxxxxxxxxx. Results indicated that a significant reduction of some mechanical properties ha d occurred compared to devices that had not been implanted. These results were misinterpreted in a manner to conceal the relative change compared to control devices such that only absolute changes were reported during implantation. This presentation of the data yielded the apparent result of minimal degradation. No further testing was conducted to determine the origin of the discrepancies between control and explant test results. The original version of the report including control device data from PPQ manufacturing support and presenting percent retention of mechanical properties, in some instances showing a 50 % loss, is an electronic copy retained in Xxxxxxx Mentor directory.

4) Device Projection Fatigue Testing

Mechanical testing of device lifetime from fatigue has been underway since the deficiency submission. The influence of device projection on fatigue lifetime was investigated. Results showed that the device projection and lifetime were inversely proportional. In other words, as the device projection increased the estimated lifetime decreased. Both smooth and textured high profile devices yielded fatigue data statistically unique from moderate profile devices with a corresponding shorter lifetime. This has not been communicated with the FDA. Since I was the only scientist aware of this and I have separated from Mentor I don't know if this will ever be revealed or reported. The raw data for this work in on my desk in a folder label RPG Addendum I or it may also be in Xxxxxxxxxx office area since she was conducting the experiments. Coincidentally the same outcome for CPG was encountered after the PMA submission also indicating the higher profile devices have an apparent shorter lifetime. I'm certain this has also been concealed from FDA.

5) Platinum Valence

Chemical test data exists that indicates platinum is present in the shell with valence Pt (II). This is far more toxic than platinum valence Pt (0) which is the chemical species currently used for potential toxicological exposure. This information has not been communicated with the FDA. The work was conducted by Xxxxxxxxxx who was informed not to publish that information. I believe the results for gel showing Pt(0) were being prepared as a publication at the time of my separation from Mentor. The interim report showing the Pt(II) valence in shelll components is on my desk in a folder labeled Platinum. In addition Xxxxxxxxx has a copy in her office area since was a participant in this project.

It should be noted that much of this new data was generated after the PMA submission and that Xxxxxxxx would not support further updates since it may influence the decision of FDA to approve the RPG product. Much of Mentor personnel have been terminated after the divestiture of Urology. Only xxxxxxxx are still employed in R&D in Santa Barbara. Xxxxx is now part of Coloplast. Xxxxxx has retired. Accordingly it is unlikely if any of this information will ever be shared with the FDA. It is my understanding the laboratory is slated for complete shutdown in the next 90 days.

Xxxxxxxxxxxxx PhD.
(former Mentor Employee)

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