[Evaluation of the tolerability of Hydrogel breast implants: a pilot study].
BACKGROUND
During the 90s the widely publicised controversy regarding the use of silicone gel breast implants stimulated research into alternative alloplastic filling materials. In this context, a new type of breast implant, containing Carboxymethylcellulose at 3.7% in the form of Hydrogel, was introduced into the European market.


METHODS
A preliminary pilot study was carried out to evaluate the tolerability and reliability of breast implants pre-filled with Hydrogel. A group of 12 consecutive patients was recruited for this purpose and underwent plastic surgery for breast augmentation or reconstruction (20 implants) at the Department of Plastic and Reconstructive Surgery at the University of Genoa between December 1996 and October 1997. All patients were then followed up for a minimum of 3.5 years. The mean age of patients was 50 years and ranged from 28 to 67 years old. After surgery the patients were examined at 4 weeks (evaluation of any immediate complications), 3 months, 6 months and 1 year (evaluation of any delayed complications).


RESULTS
No immediate complications were reported in any patient. After 3.5 years of follow-up, the degree of capsular contraction according to Baker in these patients varies between 1 and 2. In general, the implants were very soft to touch even some time after surgery, above all in patients undergoing breast augmentation. Four implants (20%) were removed from 3 patients for reasons unconnected to the implants themselves (because of neoplasm in one case and due to inadequate volume in the other two patients). No case of rupture has been reported.


CONCLUSIONS
This pilot study appears to confirm the validity of implants prefilled with Hydrogel in reconstructive or cosmetic breast surgery. A larger population and longer periods of minimum follow-up are obviously required to confirm these results over the long term.
Cicchetti
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Cattedra di Chirurgia Plastica e Ricostruttiva, IST (Istituto Nazionale per la Ricerca sul Cancro), Università degli Studi, Genova, Italy. silviacic@yahoo.it
Leone
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Franchelli
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Santi
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PL
D000328:Adult; D000368:Aged; D018427:Breast Implants / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D008875:Middle Aged; D010865:Pilot Projects
D020136:Hydrogel, Polyethylene Glycol Dimethacrylate