AN 1999(01) Trilucent™ breast implants: Voluntary recall

Please note that contact names and/or numbers may have changed since this notice was published. If you need to contact us about a particular notice, please  email dts@mhra.gsi.gov.uk quoting the reference number and title of the notice.

_________________________________

March 1999

MANUFACTURER/SUPPLIER
Lipomatrix Inc/Collagen Aesthetics International Inc

ISSUE
Voluntary recall of Trilucent™ breast implants because of concerns about long term safety.

IMMEDIATE ACTION

1. Do not implant Trilucent™ breast implants.
2. Identify all stocks of Trilucent™ breast implants and return them to a Lipomatrix Inc representative.
3. Identify all patients implanted with Trilucent ™ breast implants (for further information, see Annex 1).
4. Inform MDA of any adverse incidents involving Trilucent™ breast implants.

DISTRIBUTION REQUIRED
Please bring this advice to the attention of all who need to know or be aware of it. This will include distribution by:

TRUSTS to:

• Liaison Officers (for onward distribution)
• Plastic and Cosmetic Surgeons and all surgeons involved in breast reconstruction
• Directors of surgical units involved in breast reconstruction
• Specialist Nurses involved in breast cancer care
• All Theatre Staff and Theatre Staff Liaison Officers
• Supplies Departments

HEALTH AUTHORITIES to:

• Liaison Officers (for onward distribution)
• Registration Inspection Units
• General Medical Practitioners and Practice Nurses
• Private Hospitals and clinics involved in cosmetic/plastic surgery

BACKGROUND
The supplier estimates that since Trilucent™ breast implants were first marketed in 1995, over 9000 have been sold in the UK, representing in the order of 5,000 women having these devices.

Trilucent™ breast implants consist of a silicone elastomer shell containing a lipid filler derived from soyabean oil. Chemical breakdown of the lipid filler occurs in the body following lipid leak through the intact implant shell or shell rupture. The extent of chemical breakdown of the filler in intact implants is not known.

MDA has received 74 adverse incident reports on Trilucent™ breast implants from clinicians and the supplier, including some reports of swelling, generally associated with implant rupture. The underlying aetiology of the swelling is unknown but it may be due to a local inflammatory response. This local swelling is believed to resolve once the ruptured implant has been removed.

As a result of concerns arising from investigation of the reported adverse incidents, MDA requested relevant technical information from the supplier. Review of this information has revealed that the degree of chemical breakdown of the filler found in implants removed from women is in some cases significantly different than that predicted during pre-clinical testing. This breakdown results in some biologically active substances the toxicology of which has not been adequately evaluated.

In the light of MDA’s concerns over long term safety of degraded filler to patients, the supplier has, as a precautionary measure, voluntarily withdrawn Trilucent™ breast implants from the UK market.

FUTURE INVESTIGATIONS
The Department of Health (DH) is working with the supplier to review the available clinical and toxicological data and to identify further testing which may be required. DH will provide the results of these investigations as soon they are available.

ENQUIRIES
Enquiries to the MDA should quote reference number DEF 55/27/99020505.

_________________________________

Annex 1

GUIDANCE ON CONSULTATION WITH WOMEN IMPLANTED WITH TRILUCENTTM
BREAST IMPLANTS

The Medical Devices Agency and the Department of Health, give the following advice on which they have consulted with the relevant professional organisations.

Need for consultation
Women who believe that they may have Trilucent™ breast implants should either make an
appointment with their General Medical Practitioner or consult the surgeon who carried out the
initial implantation or another suitably qualified clinician.

General advice
The Department of Health is setting up a 24-hour Health Alert Line on 0800 004440 for women
with Trilucent™ breast implants who are worried about the possible effects on their health.
Women can also ring the Health Information Service on 0800 665544 or, where it is available
NHS Direct.

Payment for consultation
Arrangements for reimbursement for further consultation are under discussion.

Points to be discussed during the consultation
The following points are listed as guidance to clinicians carrying out consultation with women implanted with Trilucent™ breast implants:

• the reason for the withdrawal of supplies of Trilucent™ breast implants
• that there are currently no safety data to suggest removal of Trilucent™ breast implants is
  indicated
• that women should be advised to seek an immediate consultation if they notice unusual
  breast swelling or inflammation associated with a Trilucent™ breast implant
• the need for future clinical follow up
• any decision to remove Trilucent™ breast implants should be taken jointly by the woman
  and her clinician, based upon the individual clinical circumstances of each woman
• some women with Trilucent™ breast implants maybe identified through the presence of a
  transponder
• MRI should not be carried out because this may cause damage from heating up the transponder.