FDA Slams Breast Implant Makers in Warning Letters Days Before Federal Hearing that Could Ban Them from the US Market

Mia de Graff, The Daily Mail: March 20, 2019.

Days before a hearing on breast implant safety, US regulators have sent warning letters to two of the top implant manufacturers involved.

In the letters, the US Food and Drug Administration reprimanded Mentor and Sientra for historically failing to complete the safety studies required for medical devices to stay on the market.

If the firms do not have completed data within 15 days, the FDA warned, their blockbuster silicone implants could be pulled from the market.

The warning is a gesture to patients that the FDA intends to be firm with breast implant manufacturers, whose products have stayed on the market for years without adequate safety data, despite ranking in the highest-risk bracket for medical devices.

It comes amid global concerns over the safety of silicone breast implants, which have been officially linked to cancer of the immune system, and are alleged to cause autoimmune disorders.

Dr Diana Zuckerman, president of the National Center for Health Research, said the letters were ‘surprising but encouraging’ for US patients. 

‘I was surprised, but this is not the first time that the FDA has sent warning letters to implant companies that they are not complying with their research requirements,’ Dr Zuckerman, a scientist who studies patient data and health after years in Congress overseeing committees on medical devices, told DailyMail.com. 

‘The important question is what the impact of those letters will be. Will the letters scare the companies enough that they improve their research? If not, will the FDA rescind approval of their products? 

‘The FDA has never rescinded approval of a device in those circumstances, and as long as FDA doesn’t follow through on their threats, the companies don’t have an incentive to improve their research.

‘And if the research isn’t improved, patients will still lack the information they need to make informed medical decisions.’ 

The US banned silicone implants in 1992, after 10 years of pushing industry for safety data to no avail.

But companies immediately mounted plans to get the incredibly lucrative product back into the most lucrative market.

Conferring with the FDA, they were able to keep administering the products to women in the US for the purpose of research.

The firms presented their data in 2004, but the FDA rejected their application as poor in quality. Seventy-five percent of women dropped out of the Mentor trial before their first follow-up.

In 2006, firms submitted three years of data – far less than the 10 years required – and the FDA conceded, on the grounds that companies engage in rigorous 10-year studies including at least 40,000 women.

Specifically, the FDA wanted to know the risks of rupture, leaks, scars contracting, difficulties performing mammograms around implants, links to lupus, and links to cancer.

To this date, nobody has seen complete data from those studies the firms promised to complete.

Until 2011, these gaps in data were dismissed as a work in progress.

But then the FDA, alongside regulators around the world, published a statement saying there is strong evidence silicone breast implants are linked to BIA-ALCL, a rare cancer of the immune system.

Since, thousands of women have reported autoimmune reactions, ruptures, scars contracting, and cancer.

Earlier this year, the FDA published data showing nine women have died and 457 have contracted BIA-ALCL related to breast implants.

The hearing on Monday and Tuesday is a bid to interrogate all of the major players in the market, amid pressure from researchers, patient groups, and other regulators around the world (France, for example, has banned Allergan’s silicone implants).

The letters sent out to Mentor and Sientra focused on two products in particular.

See the original story here.