Friday, 9 December 2011

All Breast Implants - MEDICAL DEVICE ALERT

Article by
Kevin Timms
The MHRA has reported that there is uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma of the breast. The MHRA commented in a Medical Device Alert on 16 February 2011 as follows:

“The FDA recently published a Safety Communication entitled ‘FDA Medical Device Safety Communication:

Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants


In a thorough review of scientific literature published from January 1997 to May 2010, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world. The FDA’s adverse event reporting systems also contains 17 reports of ALCL in women with breast implants. This is a very small fraction of the 5-10 million women who have received breast implants worldwide.

Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin’s lymphoma (NHL), a cancer involving the cells of the immune system. It is a very rare tumour in the breast, accounting for less than 1% of all breast malignancies.

To date there have been no corresponding reports of this disease association to the MHRA. The MHRA encourages all surgeons to report all adverse incidents, including cases of ALCL, to the adverse incident centre (aic@mhra.gsi.gov.uk).

The MHRA will review any evidence that comes to light and take appropriate action as needed.
There is no indication for any routine action in the form of explantation or regular radiological examination including MRI. Women should be advised to self examine and consult their medical practitioner if they notice any changes in the breast or have any concerns."

The MHRA Medical Device Alert has stated that the MHRA has not received any reports of ALCL.
Garden House Solicitors are currently acting on behalf of a number of women who have been provided with defective PIP breast implant. If you have concerns about an irregularity with your breast implants we suggest that you seek medical advice from their GP or surgeon.

If you have suffered and abnormally early rupture which has not been as a result of excessive trauma, you breast implant may be defective. If you do have defective breast implants you may be entitled to make a product liability claim.

Please contact Kevin Timms in the product liability team at Garden House Solicitors on 01992 422 128 or email him at kevin@gardenhousesolicitors.co.uk if you believe you may be entitled to make a product liability claim.

Please note that this post is for information purposes and the MHRA Medical Device Alert is not intended to alarm women with breast implant but rather to highlight recent studies.

http://www.gardenhousesolicitors.co.uk/ Tel: 01992 422 128

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