Lawsuit Filed Over Allergan Breast Implants After FDA Recommends Boxed Warning
Health Canada has barred the sale of a brand of breast implant that has been linked to a rare form of cancer. According to a CBC news report, Health Canada has suspended the licenses of Ireland-based Allergan for its Biocell implants after finding significantly higher rates of a type of non-Hodgkin lymphoma among patients implanted with the macro-textured breast implants. Biocell implants are the only textured breast implants available in Canada.
Implants Still Available in the U.S.
These implants have been linked to breast implant associated anaplastic large cell lymphoma (BIA-ALCL), a type of cancer that attacks the immune system. It’s not cancer of the breast tissue. This move by Health Canada bans the sale or import of five Biocell products in Canada. A joint investigation by CBC News, Radio-Canada, the Toronto Star and the Washington-based International Consortium of Investigative Journalists found deaths and serious injuries potentially tied to breast implants and other medical devices that is underreported in many countries, including the United States.
Even though Allergan has recalled its implants from Canada, the company maintains its products are safe. Health Canada has received 26 confirmed cases of breast-implant related cancer in Canada of which 85 percent are linked to Biocell implants. The agency says the risk of BIA-ALCL are one in 3,565 with Biocell implants compared to one in 16,703 for a brand of micro-textured breast implants from another manufacturer.
No cases of cancer have been reported in Canada with any smooth-surface implants. The agency said it is not recommended that people remove Biocell or other implants if they don’t have any cancer symptoms. Those who have these implants are urged to discuss the matter with their healthcare providers. Textured breast implants have rough surfaces. France has also pulled macro-textured implants from its market. However, the U.S. Food and Drug Administration (FDA) has reviewed these implants and their cancer risk, but hasn’t pulled them from the market.
If You Have Been Affected
Some questions you may want to consider if you think you’ve been affected.
- What physical symptoms are you having?
- Have you received a cancer diagnosis?
- Who’s your cancer specialist?
- What cancer have you been diagnosed with?
- When were you diagnosed?
- What treatment have you received?
- What treatment is planned?
- What is your prognosis?
- Information about the implant – when, where, by whom. How do you know you had a bio cell textured implant? Do you have copies of medical records relating to the implant?
- Have you received a recall notice? Who sent you the notice. What date did you receive it?
If you have received this or any other brand of macro-textured breast implants and are suffering from lymphoma, you may be able to file a product liability lawsuit against the medical device manufacturer. You may be able to seek compensation for damages including medical expenses, lost income, cost of surgery, rehabilitation, ongoing treatment, pain and suffering and emotional distress. An experienced product defect lawyer will be able to better advise you regarding your legal rights and options.