Fw: Information has been posted regarding McGhan and Mentor

[Guest guest]

Thanks to for this report!

MM

Martha Murdock, Director

National Silicone Implant Foundation | Dallas Headquarters

" Supporting Survivors of Medical Implant Devices "

4416 Willow Lane

Dallas, TX 75244-7537

----- Original Message -----

From: <S3733@...>

<S3733@...>

Sent: Tuesday, July 09, 2002 6:17 PM

Subject: Information has been posted regarding McGhan and Mentor

> Please post the following on your e-mail list:

>

> Information has been posted regarding McGhan and Mentor five years post

> approval study on saline-filled breast implants. You can access this

> information at http://www.fda.gov/cdrh/panelmtg.html. Click on #12

(Devices

> and Radiological Health). Click on Text (Briefing Info for the July 9th,

> 2002 General & Plastic Surgery Devices Panel). Click on DOC for McGhan or

> Mentor.

> Summary of important information on Mentor five year study includes:

> (1) At the end of three years approximately 25% of patients were lost to

> follow-up.

> (2) Mentor has only recently improved their efforts to contact patients.

> (3) At the end of five years, the number of patients with any data was

only

> 54% for augmentation patients.

> (4) Since March 2002, Mentor has provided FDA with weekly updates of

their

> contact efforts.

> (5) Mentor confirmed that 199 patient discontinuations were not sent

> questionnaires and 3 physicians comprised 96 discontinuations due to

> physician request.

> (6) Based on the large number of patient lost to follow-up, FDA requested

> Mentor to access for non response bias and adjust the data for

non-response

> bias.

> (7) In summary, even with Mentor's generous definition of a responder,

> which is still only approximately half of the entire cohort - 909 of the

> 1601 patients (57%) ...it is problematic to generalize the results from

the

> responders to the entire cohort of patients.

> (8) Because of the numerous differences between the responders and

> non-responders, interpretation of the Kaplan-Meir complication risk rates

as

> being applicable to the entire population is not possible. The low

response

> rate and the difference between the responders and the non-responders is a

> major limitation of this study.

> (9) Mentor submitted this (a re-analysis of the estimation of the

> cumulative incidence of complications and re-operations) the first week of

> June; however, it is still under FDA review.

> (10) Table 7 reports re-operation rate at 5 years (43%) Implant removal

> (30.3%) Capsular contracture (29.4%) Breast pain (18.0%) Implant deflation

> (16.6%)

> (11) On a by patient basis, the most common reasons for re-operation were

> leakage/deflation/rupture (29.3%) patient request for size/shape change

> (26.3%) capsular contracture (19.7%) and wrinkling (11.1%).

> (12) Table 8 - 6.6% of augmentation patients listed infection as a reason

> for reoperation.

> (13) Table 9 - 17.3% of reconstruction patients listed infection as a

reason

> for reoperation.

> (14) Table 11 - For reconstruction patients at five years, 21.5% list

> infection, 5.2% list necrosis (skin death), with other listed (4.4%) as a

> reason for reoperation. Mentor has been asked to determine the primary

> reason for removal of the 6 implants (listed as other) and then the table

> will be modified accordingly.

> (14) Focus Study Group - women reported that brochure content, on the

whole,

> was clear and easy to understand with the exception of the clinical

studies

> section. Most women had difficulty in understanding and/or interpreting

the

> safety data, so they tended to skip over this section.

> *note from - Mentor has been under a consent decree for violations

> of good manufacturing practices. The Office of Criminal Investigation

(OCI)

> at the FDA began an investigation of Mentor in 1998 regarding

> under-reporting of complications among other allegations.

>

> Keeling, President and Founding Director

> CANDO (Chemically Associated Neurological DisOrders)

> P.O. Box 682633

> Houston, Tx. 77268-2633

> 281/444-0662

>

>