Biocell (breast implants)

2019: A response because of high risk of development of cancer

On July 24, 2019 the Allergan company announced that it withdraws the textured implants of a breast of Biocell and fabric expanders from the market. As the reason of recall concerns concerning the rare form of cancer known as the anaplastichesky krupnokletochny lymphoma connected with an implant of a mammary gland (BIA-ALCL) served.

Use of the textured implants is not necessary, but is shown in certain situations where the texture of an implant has the proved advantages. The textured implants in certain cases are more convenient as their uneven surface reduces the probability of movement and change of provision of an implant in a breast. They are more often used in Europe, than in the USA, however only 10% of all chest implants sold in these countries fall to their share.

Silicone breasts cause cancer. The countries started withdrawing them

The chief deputy commissioner of FDA Amy Abernethy noted that as soon as researchers obtained the evidence indicating significant harm for patients from implants of production of Allergan, regulatory bodies of the USA took necessary measures. In particular, the producer was immediately warned about correctness of earlier revealed risks and called for adoption of restrictive measures.

The Allergan company already stopped sale of the textured Biocell implants in Europe and Canada and reminded that the response does not concern smooth implants of Natrelle and implants of Microcell. According to the analyst of Stifel Annabel Samimy, the latest news can affect demand and for smooth implants of a breast of production of Allergan. Besides, the companies threaten numerous legal claims.

Nevertheless, it is considered that the direct effect of a withdrawal of the textured implants of Allergan from the market was insignificant for the company. At least, prolonged investigation did not frighten off pharmaceutical company AbbVie which purchased Allergan for $63 million.

Other textured implants sold in the USA are made by Sientra and Mentor companies, division Johnson&Johnson. Earlier regulatory bodies warned about the increased risk of BIA-ALCL at application of the textured implants, however this warning concerned generally implants of Biocell of production of Allergan as at their use the risk is approximately six times higher in comparison with the textured implants of other producers.

A number of models of chest implants withdraw in the USA because of threat of oncological diseases

According to data of regulatory bodies, as of July 6, 2019 573 cases of BIA-ALCL were around the world registered, and 481 patients at the time of establishment of the diagnosis had textured implants of Allergan. The director of Supervisory center for devices and radiological health of FDA Jeff Shuren told what regulatory bodies still find out whether the risk of development of BIA-ALCL by specific models of the textured breast implants is limited, or it concerns all implants.

On June 27, 2019 in Russia the round table "A new view on security of chest implants took place: be or not be" on which experts discussed the arisen problem. The Russian doctors believe that there are no bases for prohibition of the textured implants, but need to systematize process of collection of information in these cases ripened. Some specialists consider that in Russia it is necessary to create the register of all set chest implants as already becomes in other countries. Besides, it is decided to increase training duration in an internship on plastic surgery up to 5 years, having included in the new educational standard the expanded block on oncology.^[1]

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