Great suggestion for Op Ed article on Mentor investigation!

[Guest guest]

--- Pam Dowd <ivotepam47@...> wrote:

> From: " Pam Dowd " <ivotepam47@...>

> <Undisclosed-Recipient:;>

> Subject: FDA investigates Mentor

> Date: Thu, 26 Jan 2006 17:26:36 -0700

>

> This came in from Dr. Zuckerman today. Please pass

> along and consider writing a letter regarding this

> investigation to the editor in the largest newspaper

> in your state. I believe it is important for media

> to realize we hold the truth in our hands and we are

> not giving up.

>

>

>

> Most newspapers have a limit on letters to the

> editor. Most are 200 words and a few may be as many

> as 400. If you can get the editor to let you

> provide an op-ed, that would be even better.

>

>

>

> Thanks.

>

>

>

> Pam

>

>

>

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> FDA Week, January 24, 2006

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> FDA Criminal Investigation Shop Looks Into Breast

> Implant Allegations

>

> FDA's Office of Criminal Investigation is

> interviewing people about the rupture data that

> Mentor submitted to FDA on its textured silicone

> breast implants, sources say. One of at least two

> interviewees include a former Mentor employee who

> last year alleged the company hid rupture

> data from the agency.

>

> It is unclear if the OCI is on a fact finding

> mission or pursuing a formal investigation. An FDA

> spokesperson would neither confirm nor deny an

> investigation is underway.

>

> Sources say an OCI investigator asked those

> interviewed about rupture data that Mentor gave FDA

> as part of a multi-product approval package. The

> investigator also asked general questions about the

> company's practices, the sources say.

>

> The former Mentor employee spoke with OCI Dec. 19 in

> FDA's Dallas office.

>

> A Mentor spokesperson says the company has given FDA

> all rupture complaints from product evaluations,

> warranties, clinical study departments or any other

> source. Mentor has told FDA Week in the past that it

> remains confident that its product will be approved,

> and points out in a company statement that the

> former employee was indicted by a Texas district

> attorney for stealing Mentor implants and selling

> them on eBay. In a letter to FDA last November, the

> former Mentor employee alleged

> that Mentor hid rupture data from FDA.

>

> " The textured silicone gel breast implants made by

> Mentor have a design flaw that results in a higher

> rupture rate than [the company's] smooth shell

> implants, " the former employee wrote. " That higher

> rupture rate has not been accurately reported to the

> FDA. "

>

> The former employee told OCI investigators of

> hearing conversations while at Mentor that warranty

> claims for the textured implant were much higher

> than the number of defects doctors reported, the

> former employee tells FDA Week. The former employee

> also reports telling OCI that the company may have

> categorized leaks under other defects like joint

> failures or patch failures.

>

> The former employee worked in Mentor's research and

> development department and stresses to FDA Week that

> this division is not privy to product quality data.

> The former employee told OCI of hearing that the

> company hid data from another employee who

> transferred from product evaluation to research and

> development, the former employee says.

>

>

> The OCI investigator may interview this employee,

> sources say.

>

> Textured implants are made with two layers of

> silicone to prevent the prosthesis from moving

> around, the former employee explains to FDA Week.

> Over time, the rubbing between the two layers can

> result in tiny fractures and lead to ruptures.

>

> The texturing process is used to make some saline

> implants as well, which Mentor already has on the

> market.

>

> The former employee also alleged in the letter to

> FDA that Mentor may have misled patients by

> supplying doctors with sample implants that use a

> low-bleed patch that leaks less than those used in

> surgery (see FDA Week, Dec. 16). Previously, FDA

> Week reported that FDA thinks the

> company likely did nothing wrong by giving doctors a

> demonstration implant that is different from the one

> used in surgery unless Mentor purposely misled

> patients.

>

> Sources close to the investigation say the

> demonstration models do not appear to be the focus

> of the OCI investigation.

>

> Drug lawyers say it is unusual for the OCI to

> investigate a company that is not involved in

> product diversion or counterfeiting.

>

> " It's significance is that they've decided that [the

> accusations] are serious enough to dedicate

> resources to, " one drug lawyer said.

>

> Another drug lawyer points out that the Department

> of Justice does not have to approve cases that OCI

> brings. Instead, OCI can bring the case directly to

> a U.S. Attorney General, which bypasses some

> bureaucracy, the lawyer says.

>

> Breast implants are also the subject of a Senate

> health committee investigation.

>

> Last year, Sen. Mike Enzi's (R-WY) committee started

> looking into financial conflicts on the FDA advisory

> committee that recommended Mentor's implants be

> approved for general use. A committee spokesperson

> says the panel is also taking into account the

> former employee's accusations. Other legislators

> also have talked to the former employee, sources

> say.

>

> Silicone implants currently are only available to

> women who need them for reconstructive surgery, but

> they have been widely used nonetheless. Opponents of

> the product say even small silicone leaks caused by

> cracks or ruptures could be harmful to women.

>

> Mentor wants to put its silicone implants on the

> market for general use. The company last summer

> received an " approvable " letter from FDA for

> marketing the product. FDA stated it would approve

> the device if the company meets certain conditions.

> FDA and Mentor are not allowed to talk about these

> conditions.--Catharine Richert

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> WASHINGTON, Jan 25 (Reuters) - A consumer activist

> and a former Mentor Corp. (MNT.N: Quote, Profile,

> Research) employee said on Wednesday they had been

> interviewed by U.S. criminal investigators about the

> company's experimental silicone breast implants.

>

> Zuckerman, president of the National Research

> Center for Women & Families, told Reuters she spoke

> last Friday with investigators from the Food and

> Drug Administration's (FDA) Office of Criminal

> Investigations.

>

> Zuckerman, who has questioned the long-term safety

> of silicone implants, said she was asked in part to

> recount allegations from former or current Mentor

> employees who had told her the company failed to

> accurately report the difference in rupture rates

> between smooth and textured implants.

>

> Mentor said in a statement: " We have not been

> notified by the FDA of an investigation regarding

> that issue. "

>

> A former Mentor employee also said in an interview

> he was questioned by an FDA criminal investigator in

> December. He spoke to Reuters on condition of

> anonymity.

>

> FDA spokeswoman Bro said she could not confirm

> or deny whether the FDA had launched a criminal

> probe of Mentor.

>

> Mentor and rival Inamed Corp. (IMDC.O: Quote,

> Profile, Research) are seeking FDA approval for

> silicone breast implants. The FDA has told both

> companies it would approve the implants for sale if

> certain conditions are met. The conditions have not

> been disclosed.

>

> Zuckerman said FDA investigators asked her about

> allegations from three former and one current Mentor

> employee who had contacted her.

>

> The investigators asked in part about charges that

> Mentor did not report rupture rates for the implants

> accurately.

>

> " That's one thing I know interested (the

> investigators), the idea that the rupture rate is

> higher than has been reported, " Zuckerman said.

>

> Zuckerman said she had no way of knowing whether any

> of the allegations were true.

>

> Mentor said the company had reported all rupture

> complaints to the FDA and that its Texas

> manufacturing facility had been audited annually by

> the FDA and international regulators since 1999.

>

> " This FDA audit included a review of the complaint

> reporting process and no issues with that process

> were identified, " the company said.

>

> The former Mentor employee, an engineer who said he

> was interviewed in December, said he also spoke at

> the same time with two officers from the FDA's

> Office of Compliance, which makes sure companies

> follow device regulations.

>

> The former employee said he was questioned about his

> charges that Mentor used a " low-bleed " patch for the

> implants that women try on externally for size,

> while a higher-bleed patch was used in devices put

> into women's bodies.

>

> Such patches seal the opening through which the

> silicone gel is placed in the implant.

>

> Mentor said in December those allegations were

> " wrong " and that the engineer had been indicted for

> stealing implants from the company and trying to

> sell them.

>

> The engineer said he directed the investigators to

> others to contact about allegations regarding

> rupture rates.

>

>

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