New Research Suggests PIP Implant Failures Significantly Higher Than Previously Thought

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Women's Health / Gynecology
Article Date: 18 Apr 2012 - 0:00 PDT Current ratings for:
'New Research Suggests PIP Implant Failures Significantly Higher Than Previously Thought'

New research published in the Journal of Plastic, Reconstructive and Aesthetic Surgery suggests that the failure rate of silicone breast implants manufactured by Poly Implant Prosth?se (PIP) could be as high as 33.8%.

Patients who received PIP implants either for primary or secondary breast augmentation, between January 2000 and August 2005, were studied to determine implant failure rate and other complications. Results found that 7 to 12 years after implantation the failure rate for PIP implants is in the region of 15.9-.8%.

"Previous studies have typically reported failure rates of between 2% and 5% and these estimates have been based on secondary data. In this study, all participants were scanned by ultrasound, which provides conclusive indication of rupture, rather than clinical examination which is typically used. Most previous studies were based on multiple surgeon, multiple technique, with a relatively small number of patients and shorter follow up time span," commented Mr. Jan Stanek, lead author of the study.

Concerns about the durability of PIP silicone breast implants have been expressed for several years prior to their formal withdrawal from the UK market in March 2010. Although precise details of what elements were at fault remain unclear, concerns have been raised about both the elastomer (the outer cover of the implant) and the filler gel.

In this study PIP implants were used by the plastic surgeon for both primary and secondary breast augmentation. A database of patients was constructed and each patient was offered a free consultation and referral for ultrasound scan. Chief outcome measures included secondary surgery, implant rupture rate and time to rupture.

453 patients with PIP devices were identified. Of this number, 30 had already undergone implant exchange for a variety of reasons. 180 (39.7%) could not be contacted and 19 had undergone implant removal elsewhere. Of those who could be contacted, 47 declined consultation as they had no concerns. 97 had neither clinical signs nor radiographic evidence of implant rupture and elected to remain under regular review. At the time of writing, 38 had undergone implant exchange after ultrasonographic indication of rupture.

Based on these results, if the group of non-responders had no ruptures, the overall rupture rate would be 15.9%. However, it the non-responders had the same rupture rate as those examined in the study, the overall rupture rate would be 33.8%.

Mr. Stanek indicates that all PIP implants, due to the high rupture rate and uncertainty about the nature of the silicone gel, may need to be removed. Those patients with ruptured implants will have to have them removed; those with no evidence of rupture will need to be monitored on a regular basis. Further research into the nature of the elastomer and gel filler will determine whether all PIP implants should be explanted in the future.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cosmetic medicine / plastic surgery section for the latest news on this subject. This article is "The PIP mammary prosthesis: A product recall study" M.G. Berry and Jan J. Stanek (DOI: 10.1016/j.bjps.2012.02.019); in press, ahead of print in Journal of Plastic, Reconstructive and Aesthetic Surgery, published by Elsevier.
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Peliculas Online

PiP Breast Implant Scandal, 7000 More Women May Need Replacement Or Removal UK

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Main Category: Cosmetic Medicine / Plastic Surgery
Article Date: 15 Mar 2012 - 14:00 PDT Current ratings for:
'PiP Breast Implant Scandal, 7000 More Women May Need Replacement Or Removal UK'

The UK Department of Health has issued an update on PiP breast implants scandal which struck in late 2011. Authorities have identified an additional 7,000 women in the UK that may be in need to replacement or removal of their implants, and have confirmed this should be covered under the same NHS arrangements made earlier in the year.

The additional patients have been identified from those who had surgery before 2011, where previously, the French Authorities who first investigated their local company, believed only those implants after 2001 were suspected of containing unauthorised silicone gel.

It is generally recommended that implants are replaced every ten years, so many of these women may have already elected to replace their implants, or done so under NHS care. The NHS Medical Director, Professor Sir Bruce Keogh, continues to advise that there is not enough evidence to recommend routine removal of PiP breast implants They state on their website that :

"However, we have always recommended that if women are concerned they should speak to their surgeon or GP. The NHS will support removal of PIP implants if, after this consultation, the patient still has concerns and with her doctor she decides that it is right to do so. The NHS will replace the implants if the original operation was done by the NHS. We expect the private sector to do the same for their patients.

We believe that private providers have a duty to take steps to provide appropriate after-care to patients they have treated. If a clinic that implanted PiP implants no longer exists or refuses to care for their patient - where that patient is entitled to NHS services, the NHS will support the removal of PiP implants where clinically necessary. All women should be offered the same care, whether they had their implants before or after 2001."

Health Secretary Andrew Lansley said:

"The French regulator has confirmed this week that more women may be affected by the criminal activity of the French breast implant manufacturer PiP. These women are the victims of a fraudulent company and I know this situation is causing a huge amount of anxiety. I want to reassure those affected by the news today that they will be provided with all the help they need from the NHS.

We are still working to get private clinics to live up to their responsibilities and look after their patients. Our commitment is to ensure support for all women from the NHS if needed; we will continue to press for the same standard of care or redress from private providers."

Professor Dame Sally Davies, the Chief Medical Officer said:

"The expert group advises that there is no evidence to suggest that every woman with a PiP implant should have them removed. But we know this is a worrying time for them and want them to be able to see a GP or specialist to get reassurance and have them removed if necessary. All women who had the implants put in on the NHS will be able to have them removed and replaced by the NHS. We expect private clinics to offer their patients the same care. If they refuse, the NHS will provide advice, a scan and, if necessary, remove the implants.

Private patients will not, however, be able to have their implants replaced on the NHS unless this is clinically necessary. We will be placing adverts in the weekend papers again to inform all women with PiP implants about the advice from the experts and how they can get help if they are concerned. I have also written to GPs today to remind them that we want them to help women with PiP implants."

The Department of Health is advising women with PiP implants to take three steps to reassure themselves. The steps are to:
Find out if they have PiP implants by checking their medical notes. This information can be accessed for free from clinics or through GPs. Most women who had PiP implants on the NHS should already have received a letter ... anyone who received an implant between 1997 and 2000 will be contacted in the near future.
Speak to their GP or surgeon. Women who had PiP implants on the NHS should speak to their specialist or GP and women who had them done privately should speak to their clinic.
Agree what's best for you. Women should get advice on whether or not they need a scan then discuss appropriate action with their doctor.Patients have been told that the NHS will do removals for free if the original surgery was done on the NHS. However, if the original operation was performed in a private clinic, the patient will need to speak to their clinic to see if they will replace them for free.

Further information is available at http://www.nhs.uk/Conditions/Breast-implants/Pages/PIP.

The Chief Medical Officer has written again to all GPs to set out what they should do if a private patient with PiP implants asks for their help, and to inform them about the change in advice from the French authorities. The letter is available on the NHS Choices website at http://www.nhs.uk

Written by Rupert Shepherd
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our cosmetic medicine / plastic surgery section for the latest news on this subject. Please use one of the following formats to cite this article in your essay, paper or report:

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Rupert Shepherd B.Sc. "PiP Breast Implant Scandal, 7000 More Women May Need Replacement Or Removal UK." Medical News Today. MediLexicon, Intl., 15 Mar. 2012. Web.
8 Jun. 2012. APA

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'PiP Breast Implant Scandal, 7000 More Women May Need Replacement Or Removal UK'

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View the original article here

Peliculas Online

Silicone Gel-Filled Breast Implant Approved By FDA, With Conditions

Editor's Choice
Main Category: Breast Cancer
Also Included In: Cosmetic Medicine / Plastic Surgery;  Medical Devices / Diagnostics
Article Date: 11 Mar 2012 - 0:00 PDT
Current ratings for:
'Silicone Gel-Filled Breast Implant Approved By FDA, With Conditions'

Sientra Inc's silicone gel-filled breast implant for breast reconstruction or augmentation has been approved by the FDA, as long as the company carries out post-approval studies to assess the device's long-term effectiveness, safety, and rare disease outcomes. The implant is approved for females aged at least 22 years.
These implants are surgically implanted either under the chest muscle or under breast tissue - the aim is to enlarge the breasts, or rebuild them after breast cancer surgery or some breast abnormality.
This implant has an outer shell made of silicone, and is filled will silicone gel. Shells have either a smooth or textured surface, and come in various sizes.