Message from Leonard, FDA, regarding breast implants

[Guest guest]

Mrs. Leonard sent this message in regard to a

message you'll find below . . . I'm sharing Mrs.

Leonard's response with the group because it contains

important web addresses and statments.

- Thank you Mrs. Leonard! - Rogene

--------------------------------------

This is in response to your email to the Food and Drug

Administration (FDA), regarding problems with her

breast implant.

Matters concerning physician diagnosis and treatment

of patients are considered the practice of medicine

governed by the State licensing authorities.

I suggest that she get another opinion from another

American Board Certified Plastic Surgeon. She can

contact the following association to find one in her

area.

American Society of Plastic Surgeons

888-475-2784

This is the latest FDA information on breast implants.

Silicone gel breast implants are not approved. The FDA

sent the Mentor Corporation an approval letter on July

28, 2005, requesting additional information. The FDA

sent the Inamed Corporation an approval letter on

September 22, 2005, requesting additional information.

When these companies have met the FDA requirements,

they will be approved. Presently, you can only get

them for reconstruction, or for augmentation if you

are in a study.

You can get silicone gel breast implants now but you

have to be in a study.

A study means that you will have to see the physician

periodically and be followed to see how you are doing.

I suggest that you contact the following manufacturers

to find out where and what physicians are

participating in silicone gel breast studies:

http://www.fda.gov/cdrh/breastimplants/addsources.html

When saline breast implants rupture, FDA recommends

that they be removed even though the saline solution

will be absorbed by the body. The silicone shell

should be removed. Silicone gel breast implants are

still being studied.

I suggest you look at the information at the following

website:

http://www.fda.gov/cdrh/breastimplants/consumerinfo.html

To find breast implant problems reported to the FDA,

please go to:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

For additional FDA information on breast implants,

please go to the website below:

Breast Implant Website - The breast implant website is

a valuable source of information on implant

procedures, special surgical concerns, post-operative

care, and topics to discuss with your surgeon that can

help you make your decision. The breast implant

website also includes the breast implant consumer

handbook and patient labeling for the approved Mentor

and Inamed saline-filled breast implant products. The

breast implant website is at

http://www.FDA.gov/CDRH/breastimplants/.

This is the latest information on silicone gel-filled

breast implants:

On April 11-13, 2005, FDA sought input from an

Advisory Panel of outside experts on the data

contained in the Inamed and Mentor PMAs during an open

public meeting. In a 5 to 4 vote, the Panel

recommended not approvable of the Inamed PMA. In a 7

to 2 vote, the Panel recommended approval of the

Mentor PMA with conditions. The Panel makes a

recommendation to FDA which then makes the final

decision. FDA's review of the Inamed and Mentor PMAs

continue. The Panel agenda, Panel roster, briefing

materials (e.g., sponsor information, FDA Panel memo),

and FDA slides, and Panel transcript are available at

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=593

For purchase from the FDA, Freedom of Information

Staff (FOI), 5600 Fishers Lane, HFI-35, Rockville, MD

20852, 301-827-6500 (voice) or 301-443-1726 (FAX). For

purchase from Neal R. Gross & Company, 1323 Rhode

Island Avenue, NW, Washington, DC 20005; 202-234-4433.

Cohesive gel breast implants are not approved and are

only available when you participate in a study. When

the study is completed and the manufacturer provides

FDA with the information, FDA will review the

information and make a decision as to whether they

will be approved or not approved.

Saline breast implants were approved for marketing on

May 15, 2000, and are manufactured by the Mentor

Corporation and Inamed Corporation (formerly McGhan).

MedWatch - MedWatch is the Food and Drug

Administration's (FDA) program for reporting serious

reactions and problems with medical products, such as

drugs and medical devices. The MedWatch website is at

http://www.fda.gov/medwatch/how.htm.

BI ListServe - For the latest information on breast

implants, you can subscribe or unsubscribe to the

BREASTIMPLANTS list by going to

http://www.govdelivery.com/solution/howgovdworks/subscription/

I hope the information I've provided is helpful.

M. Leonard

Public Health Advisor

Consumer Staff, HFZ-210

Division of Small Manufacturers,

International, and Consumer Assistance Office of

Communication, Education and Radiation Programs Center

for Devices and Radiological Health

Phone: 1-800-638-2041 extension 141

Fax: 1-301-443-8818

This response represents to the best of my judgment

how the device should be regulated, solely based upon

a review of the information you have provided.

This response is not a classification decision for

your device and does not constitute FDA clearance or

approval for commercial distribution.

Unless exempt from premarket notification submission

(510(k)) requirements, the official classification for

your device will appear on the final decision letter

from any premarket review. All device types

classified as exempt from the 510(k) requirements are

subject to the limitations of exemptions.

Limitations of device exemptions are found in the

device classification chapters in 21 CFR xxx.9, where

xxx refers to Parts 862-892 (e.g., 862.9, 864.9,

etc.). Please be aware, if I have indicated that I

believe your device falls within a device category

classified as exempt from premarket review

requirements, that it is your responsibility to ensure

that you meet the exemption criteria and your device

does not exceed the limitations of exemption. If your

device exceeds the limitations of exemption, you must

submit a 510(k) and receive a letter from FDA stating

that your device may be commercially distributed in

the U.S. prior to marketing your device.

This communication is consistent with 21 CFR 10.85 (k)

and constitutes an informal communication that

represents my best judgment at this time but does not

constitute an advisory opinion, does not necessarily

represent the formal position of FDA, and does not

bind or otherwise obligate or commit the agency to

the views expressed.

Cancer patient lied to - Now she's in trouble

>

> I only found this group today and would like to

> introduce me and my

> implant situation and my distrust of doctors.

>

> After a lumpectomy I was diagnosis with breast

> cancer October 2005,

> the doctor told me " if " I had a mastectomy I would

> not need any

> additional cancer treatment, later I found it to be

> a lie. I am 47

> and didn't want to live the next 30 years with only

> one breast so I

> checked into an implant and got lie #2. The plastic

> surgeon was

> quick to recommend silicone implants as perfectly

> safe and ideal for

> my small breast size. He stated that the most

> recent test results

> have given silicone implants a " clean bill of

> health " and there was

> no proof to all the bad information out on them.

>

> I told him I only wanted the one implant and it

> should match the

> remaining breast, but in his ultimate wisdom he gave

> me an implant

> nearly twice my normal size. It is a Becker implant

> half silicone

> and half saline with a port to increase or decrease

> its size. I did

> not want additional surgeries to match my breasts

> and decided not to

> have a nipple surgically put on my reconstructed

> breast. I was

> prepared to live with two different sized breast and

> get on with life.

>

> Then on March 16 I went in to have the port

> surgically removed and

> guess what, the doctor botched it, he nicked the

> tube leading to the

> implant and all the saline leaked out! Now I am

> left with a hard

> silicone lump for a breast and a decision to make.

> Do I replace the

> silicone implant or do I have them put in a saline

> implant or do I

> have them remove the implant and go through life

> with only one breast?

>

> The implant is under my chest muscle which was cut

> and a piece of

> cadavor tissue added all at the time of my

> mastectomy. If I choose

> to have the implant removed and not replaced what

> all do I need to

> tell the doctor to do and remove?? Besides the

> implant, should I

> have the cadavor tissue also removed? And in 4-5

> months is there a

> capsular that should also be removed and how will I

> know that it was

> actually taken out? Do I request the implant to be

> given back to me

> and will the doctor give it to me? Will I have

> muscle damage and arm

> weakness, what will be my recovery time?

>

> After the doctor told me he cut the tube and the

> implant needed to be

> replaced, I asked him who was going to pay for the

> additional surgery

> and he said insurance. Is my insurance company

> responsible for this

> cost? Is he? I told him I was going to call the

> Becker Implant

> company and report the implant had failed but he

> said it didn't, that

> he had cut the tube causing the leak. Is there

> anywhere I can turn

> for support or advice?

>

> Right now the implant is a hard distorted little

> lump, he claimed the

> silicone wasn't leaking but I am not so sure, I have

> a burning

> sensation in the lower part of my breast.

>

> Help me.

>