I still frequently get questions about Leroy Young's Mad Junk Science experiment failure … soybean
oil filled implants … best remembered as the "Disaster of the Tofu Titties."
Thank you to those who contact me regarding their experiences with this catastrophe ...
Here is the British Parliament report on them, the British Med Devices statement on them, followed
by a recent small Italian study.
parliament.the-stationery-office.co.uk30803.htmOpen ↗
ncbi.nlm.nih.govquery.fcgiOpen ↗
ct&itool=iconabstr
Ann Plast Surg. 2003 Sep;51(3):229-35.
Trilucent breast implants five years' experience from an Italian perspective.
Cicchetti S, Spina B, Nicolo G, Santi PL.
Department of Plastic and Reconstructive Surgery, University of Genoa, IST, National Cancer
Institute Genoa, Largo Rosanna Benzi 10, 16132 Genoa, Italy. [email hidden]
In June 2000 the Medical Devices Agency (MDA) issued a Hazard Notice recommending the explantation
of Trilucent breast implants (TBP) as a precautionary measure.
Following that recommendation, we reviewed our series of 52 patients (71 implants) operated on from
1994 to 1998 to recall and advise those still harboring TBP. We have analyzed all the recorded
adverse events in our setting before June 2000 to estimate the adverse reaction frequency and their
time relation (review series).
We have also recorded the rate of preoperative symptoms and postoperative findings in 23 patients
(29 implants) who underwent explantation after the MDA recommendation (explantation series). In
addition, some histologic observations have been made.
The rates of significant capsular contracture (Baker 3-4) and explantations were estimated using the
Kaplan-Meier method of survival analysis, and the rates of wrinkling and palpability were compared
at 1 and 5 years of follow-up.
Overall, the rate of grade 3-4 capsular contracture was approximately 45% at 6 years of follow-up
with no statistically significant difference among the reconstruction and augmentation groups. The
analysis of survival curves showed an overall rate of approximately 55% of explantations at 6 years.
Preoperatively, capsular contracture and volume modifications were the most frequent findings in the
explantation series. Postoperatively, most implants opposed inadequate resistance to the operative
stress and ruptured, showing a creamy content. Free oil has never been found in tissue surrounding
the periprosthetic capsule.
In conclusion, it appears that the TBP-claimed advantages over other available implants seem to be
inconsistent and the MDA advice appropriate. The problems related to these implants have had a great
impact on public opinion in Europe and have contributed to the implementation of the conformity
assessment procedures to be followed for medical devices: on the 4th February 2003 breast implants
were in fact reclassified as class 3 products, in order to provide the best guarantee for health
protection.The publication of a communication by the European Parliament in November 2001 gives us
hope for the future.
PMID: 12966232 [PubMed - in process]
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www.BreastImplantAwareness.org