British Journal of Plastic Surgery (2000), 53, 317 318 �9 2000 The British Association of Plastic Surgeons doi: 10.1054/bjps. 1999.3762

BRITISH JOURNAL OF ~ / PLASTIC SURGERY

Local tissue reactions to oil-based breast implant bleed

S. Choudhary, M. A. M. Cadier and B. J. Cottrell

Odstock Centre for Burns, Plastic and Maxillo-Facial Surgery, Salisbury District Hospital, Salisbury, Wiltshire, UK

SUMMARY. We present two cases (three implants) of symptomatic local tissue reactions to Trilucent breast implant bleeds. The implant shells had changed their colour and texture. Capsule histology showed foreign body reaction and inflammatory changes. These findings question the safety of these implants. �9 2000 The British Association of Plastic Surgeons

Keywords: breast augmentation, soya oil, Trilucent, inflammation.

Oil-based breast implants (Trilucent implants) have recently been withdrawn in the U K by the Depart-ment of Health (Circular CEM/CMO/9911). This was prompted by some reports of local inflammation in a small number of women with Trilucent implants. No objective data was presented with the reason for the withdrawal being given as 'not enough was known about the long term safety and the breakdown of soy- bean oil in the filler and its possible effects on the body'.

To date only one clinical report of an adverse effect has been published 1 and a literature search failed to reveal any objective features of a case of bleed or rup- ture of an oil-based implant in a clinical setting. We present two cases of Trilucent breast implant bleeds along with the gross and microscopic picture of the implant and its capsule.

Case reports

Case 1

A 62-year-old woman was referred for left breast reconstruc- tion. She had undergone a wide excision of T2N 0 breast cancer in the left breast followed by radiotherapy and tamoxifen. She had been recurrence free for 4 years prior to her referral. She underwent reconstruction with a tissue expander inserted in the subpectoral plane. This was serially inflated to 375 ml over a period of 6 months to provide a reasonable match to the size of her normal breast. As the patient was very concerned about the safety of silicone-filled breast implants, the tissue expander was replaced with a 330 ml Trilucent implant at her request. The initial result was satisfactory but after about 18 months she started complaining of pain and hardness in the reconstructed breast. A Baker grade IV capsule was noted and 30 months after implant insertion the implant was removed and a TRAM flap reconstruction was performed.

At operation the Trilucent implant, although intact, had a very bizarre appearance. It had a variegated colour with shades of yellow and brown, and was studded with whitish yellow nodules (Fig. 1). The shell of the implant was extremely friable and despite careful handling ruptured on removal. A very dense adherent capsule surrounded the implant, the anterior portion of which was removed. The whole cavity had a rancid smell.

On histological examination, the capsule consisted of thick collagen layer with the inner zone being very cellular (Fig. 2A). This inner zone contained a variety of inflammatory cells, pre- dominantly macrophages, as well as multinucleated giant cells consistent with a foreign body reaction (Fig. 2B). Multiple lipid droplets were also observed within this inner zone.

Case 2

A 35-year-old woman had undergone a bilateral breast augmentation 30 months previously with Trilucent breast implants being inserted into subglandular pockets. Two weeks postoperatively a haematoma on the right side had been evacuated. At 30 months post-implantation the patient started to complain of pain and lumpiness in both breasts, worse on the right. Baker grade II capsules were noted with the implants being readily palpable. A change of implants and capsulectomies were performed. An identical macro- scopic appearance to Case 1 was noted in both breasts with similar histological findings.

Discussion

Trilucent breast implants are filled with soybean oil and were named so, as the filler is a triglyceride mixture and the implant is radiolucent. When introduced in late 1994 in the USA and 1995 in the UK, they were hailed as a major advance in the field of breast implants. They were vigorously promoted as a safer and better alterna- tive to silicone- and saline-filled implants.

Animal studies were conducted in rabbits looking at various aspects of oil-based implant bleed and rupture over a period of 5-6 months. 2 The studies concluded that although there was a bleed of oil across the silicone elastomer shell, this was easily absorbed and meta- bolised by the surrounding tissues. Capsules were found to be thin and soft. The histology showed an acellular capsule with no foreign-body reaction or inflammation.

Despite concerns raised by some regarding the metabolism of the oil filler in the body on bleed or rup- ture of these implants, 3,4 they were declared safe and were vigorously p r o m o t e d Y No objective clinical

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318 British Journal of Plastic Surgery

e las tomer appea r s to have undergone a s ignif icant change, poss ibly as a result o f l ip id infi l t rat ion. This renders rup tu re much more likely. I t is known tha t some sil icone e l a s tomer formula t ions can absorb l ipids resul t ing in swelling and a decrease in their tensile s trength. 6

Figure 1--The Trilucent implant that was removed from case 1. The bleed of the oil filler has imparted a yellowish colour to the elastomer shell and covered the surface with whitish-yellow nodules.

f indings associa ted with the bleed or rup ture o f Tri lucent implan ts have been publ i shed to date.

The cases that are presented conf i rm the k n o w n bleed o f Tri lucent implants . 2 In m a r k e d con t ras t to the or iginal suggest ion tha t this caused no local tissue effects, our cases reveal a very signif icant i n f l ammato ry and fore ign-body response. This reac t ion may account for the s y m p t o m s in our two cases and also o f the pat ients descr ibed in the hea l th service circular. Also o f note is the presence o f mul t ip le l ipid depos i t s indicat- ing that this oil is no t readi ly absorbed. O f concern is the po ten t i a l for b r e a k d o w n of this l ipid, which is sug- gested in ou r cases no t only by the presence o f a rancid smell bu t also by the mul t ip le yel low nodules (con- f i rmed as l ipid on histology). There are no long- te rm studies that focus on this area. Lastly, the silicone

References

1. Davies DM, Kirkpatrick WNA. Lipid emulsification after implant rupture. Br J Plast Surg 1999; 52: 238.

2. Young VL, Lund H, Ueda K, Pidgeon L, Watson Schorr M, Kreeger J. Bleed of and biologic response to triglyceride filler used in radiolucent breast implants. Plast Reconstr Surg 1996; 97:1179 93.

3. Barnett MR Triglyceride-filled breast implants. Plast Reconstr Surg 1997; 99: 2105-6.

4. Brucker R, Winger EE, Sendelbach L. Bleed of and biologic response to triglyceride filler used in radiolucent breast implants. Plast Reconstr Surg 1997; 99:2107 8.

5. Emken EA. Discussion: Bleed of and biologic response to triglyceride filler used in radiolucent breast implants. Plast Reconstr Surg 1996; 97:1194-5.

6. Dole~el B, Adamirovfi L, Vondr/t6ek P, N~tprstek Z. In vivo degradation of polymers: II. Change of mechanical proper- ties and cross-link density in silicone rubber pacemaker lead insulations during long-term implantation in the human body. Biomaterials 1989; 10: 387-92.

The Authors

Sunil Choudhary MS, FRCSEd, Specialist Registrar in Plastic Surgery M. A. M. Cadier MA, MS, FRCS(Plast), Consultant Plastic Surgeon

Odstock Centre for Burns, Plastic and Maxillo-Facial Surgery

B. J. Cottrell PhD, MRCPath, Consultant Histopathologist

Salisbury District Hospital, Salisbury, Wiltshire SP2 8B J, UK.

Correspondence to Sunil Choudhary.

Paper received 21 May 1999 after revision. Accepted 5 October 1999.

Figure 2--(A) Histology of the capsule from case 1 under low magnification shows the outer zone, which consists of a thick collagen layer, and an inner zone, which is composed of fibrin admixed with inflammatory cells. (B) Histology of the capsule under high magnification shows mononuclear inflammatory infiltrate, giant cells and lipid droplets seen as lacunae.