Popular breast implant recalled worldwide after US regulators found more evidence of a link to rare cancer

  • Allergan's Biocell textured implants have a rough surface to prevent slipping
  • They have long been linked to a cancer of the immune system called BIA-ALCL 
  • The FDA contacted Allergan this week with new information on the rates of implant-related BIA-ALCL 

By Mia De Graaf Health Editor For Dailymail.com and Reuters

Published: 11:46 EDT, 24 July 2019 | Updated: 13:04 EDT, 24 July 2019

A popular type of breast implant has been recalled worldwide after US regulators found even stronger evidence of a link to a rare cancer. 

Allergan Plc said on Wednesday it was recalling its Biocell textured breast implants and tissue expanders following a report by the US Food and Drug Administration (FDA). 

The implants, which have a textured surface to prevent it slipping, have long been linked to a cancer of the immune system called BIA-ALCL (breast-implant associated anaplastic large cell lymphoma). 

The FDA contacted Allergan this week with new information on the rates of implant-related BIA-ALCL

The FDA contacted Allergan this week with new information on the rates of implant-related BIA-ALCL

The recall does not affect Allergan's Natrelle Smooth (also silicone) or Microcell breast implants and tissue expanders, the company said. 

Allergan is in the process of being acquired by drugmaker AbbVie Inc in a $63 billion deal. 

In May, the Botox-maker recalled and stopped the sale of its Biocell textured breast implants in Canada, after the country’s health regulator said the potential risks associated with the implants outweigh their benefits.

Late last year, Allergan also took its textured breast implants off the market in Europe after a French regulatory body ordered a recall.

Effective immediately, healthcare providers should no longer implant Biocell implants and unused products should be returned to Allergan, the company said on Wednesday.

HISTORY OF BREAST IMPLANTS IN THE U.S. 

1960s: Breast implants were first sold in the US, before the FDA regulated medical devices.

1976: Law changed, meaning that every medical device would be categorized into class I, II or III.

Those in the highest class (Class III) would require the most stringent checks - mainly: human clinical trials.

Breast implants, growing in popularity, were allowed to stay on the market while the FDA decided which category it should take. 

But doctors started raising concerns in that the devices seemed to trigger side effects.

1978: An FDA advisory panel suggested breast implants should be Class II.

1982: The FDA decided breast implants should be Class III. They called on industry to conduct human studies to investigate a few main concerns: 

  • the risk of rupture
  • the risk of leaks
  • scars contracting
  • that they are hard to mammogram 
  • links to lupus
  • links to cancer

1990: Congressmen berated industry for failing to present human trials. The only trials to date were silicone injections in rats and rabbits.

1991: Industry submitted human studies but they were deemed poor quality. One only lasted three months.

1992: Internal documents from people inside the industry leader at the time, Dow Corning, were leaked to the press, showing that manufacturers had concerns of risks to human health.

That was the nail in the coffin. The FDA decided to ban silicone implants for women unless they were part of 'adjunct' trials to assess their safety. 

2003/4: The FDA rejected the data presented by Inamed (now called Allergan) and Mentor (now part of J&J), saying they were poor quality. Seventy-five percent of women dropped out of the Mentor trial before their first follow-up. 

The FDA then published guidance on what the trials should consist of. They needed to answer why implants break, leak, and how long implants last. 

2005: Mentor and Inamed submitted three-year-long studies, which were criticized as inadequate by the FDA.

2006: The FDA re-approved silicone implants, but ordered device makers to conduct six trials spanning 10 years with at least 40,000 women. 

2011: No data had been published. The National Center for Health Research, a patient advocacy group, lobbied congress for answers. The FDA published data online later that year, showing the studies were not completed. Three-quarters of women dropped out of the Mentor study, and 40 percent dropped out of the Allergan study.

Popular breast implant recalled worldwide after more evidence of a link to rare cancer

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