My WonderLand - @gfzambrano

As noted in prior posts below, #silicone breast implants have been given a seal of approval by the FDA based upon data provided by manufacturers regarding their safety and efficacy. The once banned implants have returned as an option for women. However, during recent meeting of an FDA advisory panel consumer advocates were renewing calls to have the silicone implants banned or recalled. In “Consumer Groups: Stop Sale of J&J Breast Implants”, REUTERS reporter, A. Yukhananov, reported on the National Organization for Women Foundation and the National Research Center for Women and Families appearance at the two-day FDA advisory panel meetings to discuss needed follow up studies for silicone implants. This story notes that Johnson & Johnson’s “Mentor” unit, and Allergan’s, silicone implants were approved conditionally approved for sale in 2006. However, the companies were required to follow 40,000 women, for 10 years, to monitor and report on safety issues.  The story cites Allergan as having collected preliminary data for only 60% of participants and J&J’s Mentor as collecting only information on only 21% of women over a 3 year period. Notably, J&J has been plagued by a company wide pandemic of recalls over the past two years across a number of markets and divisions. Their failure to obtain data on these women raises more red flags about institutional controls and could contribute to more scrutiny of their safety record.  The American Societ of Plastic surgeons estimates that in 2010, 400,000 women underwent breast enlargement or reconstruction in the US.

In 1992, the FDA had banned silicone breast implants over safety concerns. Final recommendations on how to move forward are expected following the conclusion of these hearings. For now, company representatives are making excuses about why they could not follow up with women that initially enrolled in their studies. However, with the availability of e-mail, digital technology and social media you have to openly wonder about their commitment to follow women for adverse events, as well as transparency in reporting their results.

Will there be a breast implant #recall? Despite limited data and note gaps in the manufacturers safety data, the FDA has already given the return of silicone breast implants the proverbial ‘green light’. Whether this will prove to be short sighted, or sound action, remains to be seen.

Gabriel F. Zambrano, P.A., is the sponsor of this blog and commentary. Gabriel F. Zambrano, P.A., is actively investigating cases of ALCL (Anaplastic Large Cell Lymphoma) in women that have breast implants, as well as future complications from implants.