The PIP breast implant incident does not affect the breast augmentation patients or the breast surgeons in America, as this particular silicone gel implant was not permitted for use in the country. Yet, the problems that arise due to use of substandard breast implants elsewhere could be a matter of interest to the potential breast patients and the surgeons here.

UK’s Royal College of Surgeons (RCS), a renowned institution in the field of training and education in surgery and an advisory body to the Department of Health, Health Authorities in UK on surgical issues, has addressed the final report of the expert group on PIP breast implants.

First, a little on the background of the PIP breast implant and the associated problem:

The French company Poly Implant Prothe’se (PIP), was the maker of PIP implants and had been charged by UK, France and many other governments worldwide to have fraudulently manufactured and supplied below grade silicone breast implants. An estimated 400,000 women might have used the implants. For many of these women, the breast implants ruptured spilling the illegally used industrial grade (instead of approved medical grade) silicone gels extensively into the body tissues. This raised serious medical anxieties among patients and the regulators.

The PIP silicone implants were not cleared by FDA for use in America and hence the impact of the scandal has been very little in the country. However, some American women might have received the implants in foreign countries.

The patients, the regulators and the governments have been in a dilemma on what to do with the implants fitted in the breasts, some of which may not have ruptured yet.

Under the direction of the UK government, an expert group studied the complex case and submitted the final report. The RCS has now reviewed the report and given its response, for action by the UK government. Some of the important observations by the RCS are in the following lines:

  • The collection and analysis of data from PIP implants in the final report will enable women to make more informed decisions about their own implants as well as highlighting the need to put in place mandatory data collection for all implants.
  • The five professional surgical organisations involved in breast implant surgery have updated their clinical guidance for the care of patients with PIP implants. The guidance provides patients with practical advice on what to expect and on their rights, gives information to GPs about where to refer different groups of patients and advises surgeons on treatment. The guidance is available here (attachment).
  • The College is currently drawing up a set of professional standards for cosmetic surgery and will contribute to the Government’s review of the regulation of the cosmetic surgery industry, when it begins. We are committed to working with the Government to ensure a robust, open and transparent regulatory system is in place.

Professor Norman Williams, President of The Royal College of Surgeons, said:

“The PIP breast implant issue brought into sharp focus the need for better regulation and surveillance for all surgical implants. With the publication of the final report by the expert group, it is time to look to the future to ensure no patient experiences unnecessary harm or distress from substandard surgical implants. It is the view of the College that we should, as a minimum, have mandatory databases for all surgical implants and associated techniques which would provide ongoing patient safety data.  New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our health-care system, disseminated appropriately and monitored in the long term.”

The guidance issued and referred to by RCS has three components: guidance for patients, guidance for GPs and guidance for surgeons and these are outlined below:

Guidance for patients places importance on having the details of the implant used and if not available, urges the patients to get the implant details from their surgeons or the surgical providers. In case of inability to access the surgeons or the surgery providers, they are advised to consult with their GPs. The patients are then to discuss their options with their surgeons and whether a scan is required. The guidance expects that the provider of the initial procedure will provide to the patients all information and where necessary implant removal and replacement without cost to the patient.

Guidance for GPs advises that the NHS (National Health Service) will contact the patients with the PIP implants for consultation and expects that the private providers will follow suit. It advises that as per government decision the private patients will be entitled to explantation and not re-augmentation. It also says that patients planning re-augmentation soon after explantation should be advised of increased risks of two surgeries and that the patients should not be referred for scanning without specialist surgical opinion. It then includes detailed signs and symptoms by which the GPs should assess the patients.

Guidance for Surgeons advises the surgeons and hospital specialists to examine the PIP implant patients carefully for rupture or gel leak. It then advises the surgeons in some detail on how to deal with “patients who have evidence of implant rupture/gel leak”, “patients without symptoms or signs of leak or rupture”, “Surgical procedure” and provides information on “Specific considerations for PIP-related explantation” and “Future monitoring”.

The full response document of the RCS and the final expert report on PIP implant may be referred to for further details on the guidance issuedand other matters.

Dr. Robert L. True, a cosmetic surgeon specializing in breast and body cosmetic procedures in the Dallas Fort Worth area, has never placed PIP implants in his patients. As a specialist in Breast Augmentation surgeries, he is well able to remove such implants and place new ones as needed by the patient. His philosophy is to provide the safest means for cosmetic breast surgery, and offering the Awake Breast Augmentation procedure improves this  safety. If you would like further information on his services, go to www.truemd.com.

[Source: This write up is sourced from the article Royal College of Surgeons responds to the final report of the expert group on PIP breast implants” dated 18 June 2012 issued by The Royal College of Surgeons, UK]