Breast Implants

V. (e) Soy breast implants.

The U.S. Food and Drug Administration (FDA) has placed restrictions on the use of silicone gel-filled breast implants. This has lead to new interest in developing alternative implant filler materials. One of the most promising materials is Soybean Oil. The implant has a heat-cured silicone elastomer shell which is filled with a highly refined medical grade triglyceride extracted from soybean oil. They initially were introduced in Europe in 1995. However in 1999, they were removed from the market due to increased complications.

The perceived advantages of this implant include the following:

• First, triglycerides are naturally found in the blood stream. Thus, if the implant ruptures or leaks, it is felt to be safe.
• Second, since soybean oil is 30 times more viscous than saline, it may reduce the incidence of implant wrinkling and lead to a more naturally feeling breast.
• Last, saline filled implants are radiopaque on mammography. This means they do not allow x-rays to penetrate them. The soybean oil filled implants are radiolucent, thus they allow the penetration of x-rays. This allows better visualization of the breast tissue for breast cancer screening.

These implants are currently not available in the United States do to the initial studies in Europe.

V. (e) Soy breast implants.

Soybean Oil Implant Recall

Are they safe?

New Information Questions Safety

Warning - The following is an introduction to soy implants. Please read all the way through! After the introduction is new information about a recall of soy implants in the United Kingdom.

Introduction: Soy oil-filled implants were conceived of by Dr. Leroy Young, and others at Washington University in St. Louis in the early 1990's. Their concept was to use presumably metabolizable Soy Triglyceride Oils (Trilipid Z6) to fill the implants, and thus provide a material less dense than silicone gel, or saline solution, to allow for better visualization of mammograms in the presence of implants. The goal was also to achieve a material of similar safety to saline to allow clearing once the implants eventually fail and leak.

These implants are/were manufactured by LipoMatrix of Neuchatel, Switzerland, and were generally available in Europe since 1994, and in the UK since 1995. Collagen Corporation (the makers of injectable bovine collagen) owned this company until mid-1998 and was in charge of the first stage clinical trials involving 50 implant recipients in the US. Recently, due to large financial losses, Collagen Corporation divested themselves of LipoMatrix and this soy implant study to a group of venture capital investors which apparently trades under the name Sierra Ventures. LipoMatrix was actually sold to Sierra Medical Technologies, a company that I cannot locate on an internet search. Details on current progress with the soy implant study, regarding approval by the FDA, is scarce at this point, but an official dispatch from Collagen Corporation in April 1998 suggested that market release in the US was "at least 3-5 years away."

The "feel" of these implants should be about the same as saline, although soy oil is a much less dense material, and thus will likely have the same problems as saline implants regarding wrinkling, especially if the implants are used above the muscle, with textured shells, or in very thin individuals.

Deflation rates, and results of release of large volumes of concentrated old triglyceride oil at the time of implant failure is not yet known, and more than one source has speculated about the possibility of rancid spoilage of the filler oil, although I have seen no proof of that concern.

As I see it, the only significant possible benefit of soy oil-filled implants, over current saline or silicone implants, is the improved ability to do mammography when implants are placed over the muscle, whereas saline or silicone implants will always cause significant mammography interference when placed over the muscle. I see no reason why other complication rates such as incidence of capsule contracture would be any different than for other implants.

On June 6, 2000, the following article came across the news wires from the Department of Health in England.

Copyright 2000 Crown Copyright

Hermes Database The British Government’s Department Of Health

June 6, 2000

HEADLINE: Warning Issued To Remove Trilucent Breast Implants.

New advice issued by the Government today recommends that women with Trilucent breast implants should have them removed as a precautionary measure. The guidance from an Independent Advisory Group convened by the Medical Devices Agency (MDA) follows new data on the long term safety of these oil-based implants.

These measures are precautionary. Although there have been reports of breast swelling and discomfort in a small number of women with these implants, there has been no clinical evidence of any more serious health problems. Nor has the MDA or the manufacturer received any reports of health problems in babies born to mothers with Trilucent breast implants.

Trilucent breast implants, which have a soya bean oil filling, were available between 1995 and March 1999. In March 1999 they were withdrawn from sale as a precautionary measure because of lack of information on their long-term safety.

At that time the MDA had received reports of local complications in a small number of women with these implants but there were no data to suggest that routine removal should be carried out. The MDA asked the manufacturer to carry out further toxicological testing.

This new data is preliminary but it suggests that some products created when the soya bean oil deteriorates may be harmful to women with these implants. There is insufficient data to be clear whether there is an increased risk of cancer or damage to an unborn baby. However these risks could not be excluded.

As soon as the MDA received this data it set up an Independent Advisory Group to:

• Evaluate the evidence available on the toxicity of the breakdown products of the filler material.
• Assess the resulting clinical risk and give recommendations on the most appropriate action to protect womens' health.

Based on the recommendations of the Independent Advisory Group, the MDA has issued the following advice to women with Trilucent breast implants:

• Trilucent breast implants should be removed. Women should consult with their plastic surgeon to discuss removal of the implants and options for surgery. There is no information either way on the safety of inserting a different breast implant after removal of Trilucent breast implants.
• Women should not plan a pregnancy or breast feed until after the Trilucent breast implants have been removed and should use contraception prior to removal.

The company with responsibility for these implants, AEI Inc., is working in partnership with BUPA to establish a full programme of care for women, covering consultation, implant removal, replacement with other implants where indicated and follow-up care, available in both the NHS and the private sector. There will be no charge to the women concerned.

Dr Pat Troop, Deputy Chief Medical Officer said:

"Although this is a major step for us to take, it is a precautionary one. The latest scientific data shows that this type of implant could be harmful, but, as yet, there is no evidence of actual harm to women. Therefore, I am advising today that women should have these Trilucent breast implants removed. We have been working closely with the company involved to ensure that women have all the necessary support and information they need and fast access to surgery."

"Although there is no evidence of Trilucent breast implants causing problems in unborn or newborn babies, the Independent Advisory Group have recommended that women who have Trilucent breast implants should not plan a pregnancy or breast feed their babies until after their Trilucent breast implants have been removed. The Group stressed that this advice was precautionary."

"In order to give women with Trilucent breast implants as much information and advice as possible the company has set up a Trilucent Care Centre with a 24-hour helpline. The number for women to call is 0-800 028-6622. There is also a separate number for GPs, consultants and other healthcare professionals which is 0-845 608-0808. Women can also ring the Health Information Service on 0-800 66-5544 or where available NHS Direct on 0-845 4647. Information is also available on the NHS Direct Website at www.nhsdirect.nhs.uk."

1. The MDA is an executive Agency of the Department of Health with responsibility for protecting public health where it relates to medical devices and equipment including breast implants.

2. Trilucent breast implants consist of a silicone elastomer shell containing lipid filler based on soyabean oil.

3. Approximately 5,000 women in the UK have Trilucent breast implants. It is estimated that more than 70 per cent of Trilucent implants were implanted by the private sector for cosmetic reasons.

4. MDA established an Independent Advisory Group to review the additional information now available on Trilucent breast implants. The Group was chaired by Dr J Metters Formerly Deputy Chief Medical Officer.

The members of the Group are:

• Ms H Barnett Consumer Association.
• Professor J Caldwell Professor of Biochemical Toxicology and Head of Biomedical Sciences Division, Imperial College School of Medicine.
• Professor J K Chipman, Professor of Cell Toxicology, University of Birmingham
• Professor D Davies, Professor of Clinical Pharmacology, Imperial College School of Medicine.
• Mr B Jones, President of the British Association of Aesthetic Plastic Surgeons
• Professor J Lunec, Professor of Chemical Pathology, University of Leicester
• Mr D Murray President of the British Association of Plastic Surgeons

5. The full text of the Hazard Notice issued by the MDA is on the MDA Website at www.medical-devices.gov.uk/hn2000(05).htm The statement from the Independent Advisory Group statement is at www.medical-devices.gov.uk/tbi-state.htm

6. MDA had advised the European Commission, other Member States, worldwide regulatory authorities and the Devolved Administrations of its actions.