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The following are two articles about the safety of saline breast implants approved by fda for use.

For the how to do breast surgery texts go to Text and Articles

Thursday March 2 6:54 PM ET

FDA Panel Deems 2 of 3 Breast Implant Brands Safe

y Lisa Richwine

GAITHERSBURG (Reuters) - The two most popular brands of saline-filled breast implants are safe and effective and should stay on the U.S. market, a federal advisory panel said Thursday after reviewing new data on possible complications.

The committee said, however, that the company that makes a third brand of saline implants did not present enough information to prove the benefits of its product outweighed its risks.

Saline implants first hit the market more than 25 years ago when the FDA had no authority to determine whether they were safe. The agency is scrutinizing them now because of concerns about complications such as infections and rupturing.

The FDA usually follows its panels' advice and is expected to decide whether to officially approve the implants later this year.

Breast implants are more popular than ever. About 150,000 women received them last year. Most are filled with saline, or salt water. Silicone-gel implants were banned for most women in 1992 over safety concerns.

The panel recommended the FDA approve implants made by Inamed Inc.'s (NasdaqNM:IMDC - news) McGhan Medical unit and Mentor Corp. (NasdaqNM:MNTR - news), two California companies that lead the breast implant market.

``The data shows these implants are reasonably safe and effective,'' said panel member Dr. Phyllis Chang of The University of Iowa College of Medicine after studying McGhan's results.

But panelists said they were not reassured by data from Poly Implant Prostheses (PIP). They said the U.S. study the company presented did not include enough patients that were followed for an adequate time to truly evaluate the device risks.

Panel member Boyd Burkhardt, a plastic surgeon from Arizona, said he wanted to support PIP's implants because he thought their design would ``dramatically'' reduce the rate of infections. But he found the company's data incomplete and found it difficult to understand that the company was ``as ill prepared as you appear to be.''

PIP President Rick Hawk responded by saying the study results showed there was, ``reasonable assurance of PIP's implant safety and effectiveness.''

Earlier, McGhan said a one-year study of more than 2,500 women showed the most common problem was contraction of scar tissue around the implants, which can cause changes in breast appearance and deflation. That occurred in 7.2 percent of women who had breast augmentation and in 12.5 percent of women who had breast reconstruction.

Leakage or deflation happened to 3.6 percent of women who had augmentation and 2.6 percent of reconstruction patients.

An FDA official who analyzed the company's studies said the risk of complications increased over time. Dr. Sahar Dawisha said 95 percent of reconstruction patients had reported some type of complication after five years.

Studies on serious ailments such as connective tissue or autoimmune diseases were not designed well enough to draw any conclusions about whether they were related to the implants, Dawisha said.  

Health

From Scientific American September 1999

SILICONE SAFE

A major report finds that silicone breast
implants don't lead to cancer


Women who have silicone breast implants are no more likely than the rest of the population to develop cancer, immunological diseases or neurological disorders, a committee of the Institute of Medicine (IOM) reported on June 21. Moreover, mothers with implants may safely breast-feed their infants, as there is no evidence of toxicity in the milk. The IOM committee drew its conclusions after holding public hearings (during which women with implants told of their experiences) and reviewing scientific literature on silicone breast implants (first made in 1962) and silicone.

The analysis--funded by the U.S. Department of Health and Human Services and the National Institute of Arthritis and Musculoskeletal and Skin Diseases--is the latest in a series to have found such results. Similar announcements were made last year by scientists who were appointed by judges overseeing implant liability litigation in the U.S. and by researchers in Britain reviewing implant safety for the British Department of Health.

Still, the IOM committee points out, breast implants are not without risks. The tissue around the implants may contract, causing pain and disfigurement and leading to infection by skin bacteria that normally reside in the lactiferous ducts of a healthy breast. Also, implants have a finite life span, and rupture rates of gel implants and the deflation frequencies of current saline models have not been determined. Problems lead to additional surgery to replace or remove them.

Not everyone is convinced by the IOM report. Some believe that a study based on other studies--called a meta-analysis--is inherently flawed because of assumptions made about the quality of previous research. In any case, implant manufacturers have already agreed to a total settlement estimated at $4 billion with plaintiffs who claimed physical harm; now-bankrupt Dow Corning will be paying the most, some $3.2 billion.


--Christina Reed

 

What Are Other Sources of Additional Information?

MENTOR CORPORATION

General Resources about Implants:

Upon request, you will be provided with a copy of the Directions for Use. You can request a copy from your surgeon or from Mentor. For more detailed information on the preclinical and clinical studies conducted by Mentor, you are referred to the Summary of Safety and Effectiveness Data for this product at http://www.fda.gov/cdrh/

You will be given a device identification card with the style and serial number of your breast implant(s).

Mentor Corporation

1-800-MENTOR8

www.mentorcorp.com

Institute of Medicine Report on the Safety of Silicone Implants

 

www.nap.edu/catalog/9618.html

Food and Drug Administration

1-888-INFO-FDA or

301-827-3990

http://www.fda.gov/cdrh/breastimplant

Breast Reconstruction Resources

The following list of resources may help you to find more information and support for your breast reconstruction decision.

National Cancer Institute

1-800-4-CANCER

cis.nci.nih.gov

American Cancer Society
(Reach to Recovery)

1-800-ACS-2345

www.cancer.org

Y-ME National Organization for Breast Cancer Information and Support

1-800-221-2141

www.y-me.org

 

MCGHAN CORPORATION


What Are Other Sources of Additional Information?

General Resources about Implants:

Upon request, you will be provided with a copy of the Directions for Use (package insert). You can request a copy from your surgeon or from McGhan. For more detailed information on the preclinical and clinical studies conducted by McGhan, you are referred to the Summary of Safety and Effectiveness Data for this product at http://www.fda.gov/cdrh/

You will be given a device identification card with the style and serial number of your breast implant(s).

McGhan Medical

1-800-624-4426

www.mcghan.com

  

FDA BOOKLETS

FDA FREEDOM OF INFORMATION

We sincerely hope that the information in this packet has been of help to you. If you need more information, please submit a written request to the FDA Freedom of Information Staff.

The Freedom of Information Act (FOIA) allows anyone to request FDA records. However, under FOIA, information that is deemed exempt from disclosure may not be released to the public. Examples of this type of information typically include: preclinical or clinical data from ongoing, completed or discontinued studies; mechanical drawings; chemical compositions; etc. For instance, FDA cannot acknowledge the existence of an investigational study unless we know that the manufacturer has gone public with that information. Even then, in most cases, no details of that study can be given per FDA regulations. We are not denying any request; however, this clarification is provided so that you do not have unrealistic expectations on what information you can obtain through FOIA.   To access additional information on FOIA, to check to see if the information you want is already on FDA’s website, to find out about FDA public reading rooms, and to access the complete handbook for requesting information through FOIA, please go to our website at http://www.fda.gov/cdrh/foicdrh.html

If you want to request information under FOIA, you must submit a written request to the following address:

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Fax: 301-443-1726
Voice Mail Message: 301-827-6500

The letter should include your name, address and telephone number, as well as a statement of the desired records, identified as specifically as possible. A request for specific information that is releasable to the public can be processed much more quickly than a request for all information on a particular subject. There are fees for searching and reviewing the information plus a charge of 10 cents per page. You are billed after your request for information has been filled.

If you have submitted a FOIA request and you have questions relating to its status, please write to:   Freedom of Information Staff (HFZ-82)

Center for Devices and Radiological Health
Food and Drug Administration
2094 Gaither Road
Rockville, MD 20850
Fax: 301-594-4792

Breast implant documents involving our recent PMA approvals for two saline-filled breast implants may be of interest to you. For example, the Summary of Safety and Effectiveness (SSE) for each PMA may be obtained through FOIA. However, the transcripts for the March 1-3, 2000 Panel meeting for these saline-filled breast implants, as well as the patient labeling, for these implants are already available on our website at http://www.fda/cdrh/breastimplants/

Note: As an alternative source of information on breast implants, you should be aware that there is a comprehensive collection of FDA breast implant documents handled by the Plaintiffs’ Liaison Counsel, which is independent from FDA and its FOIA Staff. Upon the order of Judge Pointer, FDA released all relevant breast implant information that we had up to February 1993. If the information you are seeking occurred before this date, you should consider contacting the Plaintiffs’ Liaison Counsel at the telephone number or address below.

While FDA formerly referred to this comprehensive collection as the "Pointer Compendium," the Plaintiffs’ Liaison Counsel stated that you should refer to that collection as "those documents produced by FDA to the national depository in the national breast implant litigation MDL926."

This comprehensive collection of documents, along with an objective index allowing a requestor to access these documents, is available on CD. The collection includes items such as

·        Material related to advisory panel meeting in 1991 and 1992

·        Federal Register notice for silicone gel-filled implants

·        correspondence and meeting minutes concerning silicone and breast implants

·        public statements issued by FDA

·        FDA meeting minutes discussing elements of informed consent for silicone gel-filled implants

·        documents related to compliance with FDA-imposed requirements

·        documents in FDA field offices

·        administrative files concerning breast implant manufacturers

·        10 PMA applications for silicone gel-filled breast implants as well as correspondence and other related materials

·        FDA filings in breast implant-related litigation

·        testimony prepared for Congressional hearings regarding silicone gel implants

·        material related to IND 2702 (Dow Corning’s early investigation into soft tissue augmentation with silicone fluid injections)

The Plaintiffs’ Liaison Counsel may also be contacted for general assistance and information on breast implant litigation.

Please be aware that there will be independent charges assessed for this information also. Questions on the specific contents of this comprehensive collection or requests for specific records are to be directed to:

Plaintiffs’ Liaison Counsel
2008 2nd Avenue
Birmingham, Alabama 35203
205-252-6784
Fax: 205-252-0423

The breast implant consumer handbook, along with other breast implant information, may also be obtained by visiting FDA’s website at. http://www.fda/cdrh/breastimplants

If you have any comments regarding the breast implant handbook, please write to us at FDA, Office of Device Evaluation, Division of General, Restorative, and Neurological Devices, 9200 Corporate Boulevard, HFZ-410, Rockville, MD 20850

 

 

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  1984-2014 American Society of Cosmetic Breast Surgery  Last modified: May 22, 2014