Textured Implant Recall Information

A Bit of History:

The first breast implantation of silicone-filled silicone implants was performed in 1962. These devices leaked and while the silicone stayed locked within the surgical pocket, the lining (capsule) thickened. This thickening is called a contracture. The rate of contracture back in those early days was as high as 50%. In an attempt to prevent this, the shell was textured, which helped prevent this problem. However, the skin of the chest would often stick to the textured shell and distort. Placing the smooth implant under the chest muscle served the same function, that is, it prevented contracture. Overtime the silicone shell was improved and the contracture rate was reduced to less than 5%.

Silicone Implant Ban:

Back in 1992 silicone filled silicone implants were banned because of a fear that they caused Lupus-like symptoms. This left only silicone implants that were filled with saline. Because these implants did not look as realistic as their silicone-filled counterparts, one of the implant manufacturers developed a teardrop shaped implant. It solved the initial issue, but these implants would fall over causing a distorted look. They then textured the outside using a new methodology, coining the phrase Biocell Implant.

Current Timeframe:

In November of 2006 the FDA completed their studies on the silicone-filled silicone implants and concluded that there was in fact NO evidence that implants were associated with any auto-immune diseases, cancer or any other disease state. The implant manufacturers by this time had perfected a better implant and so most surgeons began using the new ‘Gummy Implant.’ However, the Biocell shell was still being manufactured, although Dr. Freedland did not see any purpose for these since the smooth-silicone adopts a Teardrop shape on its own.

In 2011 the first reported case of BIA-ALCL cancer was reported. Since then a total of 573 patients have been identified. All of the patients that could find their records have had a Biocell Implant. Understand that the total number of implants placed, worldwide is over 10,000,000. In April 2019 France moved to ban this device. Other countries soon followed and finally the company ‘voluntarily’ took the Biocell Implants off of the market.

Now What:

Patients with this mild form of cancer have all complained about symptoms prior to the finding of BIA-ALCL. The symptoms consisted of increased fluid buildup, which can lead to pain, swelling, or lumps in the breast or armpits. The treatment is the surgical removal of the implants as well as the capsule that formed around the implant. New implants (obviously smooth, non-textured implants) can be inserted at the same time.

For patients that have had Biocell Textured implants at any time in their life who do not have symptoms are still at risk for getting this mild form of cancer even if they have had their implants replaced. Understand that removing the capsule in patients without symptoms is often difficult. So many of the patients that don’t have symptoms are choosing to replace their implants with smooth implants and have a simple biopsy of the capsule. They are then waiting to have their capsule removed if and only if they experience symptoms. In other words, most patients do not have anything to worry about.

Contact Us:

This information can be overwhelming to our patients. If you have any questions, please feel free to contact our office. If you have patients with concerns, they are welcome to set up a free consultation.

Contact Dr. Michael Freedland

Further Reading: