Poly Implant Prosthesis (PIP), a French company founded in 1991 and liquidated in 2010, was the maker of PIP breast implants. It has been held responsible in several European countries and elsewhere, to have fraudulently manufactured and supplied below grade silicone breast implants.
About 400,000 women might have used PIP silicone implants for breast enhancement (breast augmentation). 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.
On May 14, 2012, Earl Howe, the Health Minister of UK in his review of the PIP breast implant scandal, held the implant manufacturer fully responsible for the faulty implants and said that although the British Medicines and Healthcare Products Regulatory Agency (MHRA) followed sound advice during the emerging incidents of PIP failure, in future it should gather evidence from a larger group of sources, especially from clinicians.
Earl Howe’s observation on the need to especially consult with clinicians in gathering evidence in the episode, underlines the crucial role the clinicians play in breast augmentation and other cosmetic surgeries. A clinician is defined as “a doctor having direct contact with and responsibility for patients, rather than one involved with theoretical or laboratory studies.”
The impact of faulty PIP silicone implants in France, UK and other countries have been very high leaving the patients and the governments in a quandary on what to do with the faulty implants fitted in the breasts, some of which may not have ruptured yet.
The impact in America has been little, as PIP silicone implants were never approved by the FDA for use. As of now, there are only three FDA approved silicone gel-filled breast implants in the U.S.A, manufactured by Allergan, Mentor and Sientra. But some Americans might have received PIP silicone implants in foreign countries.
What are the lessons for the future patients from the PIP scandal? There are a few.
First of all, the patients must know that cosmetic surgery is a serious choice and must not be taken up “as part of a whim or medical vacation” and without due deliberation and without following due processes.
Second, the patients must not depend too much on what the manufacturers say about their implants. The patients must choose the implant through research and by consulting with the cosmetic surgeons, who have lots of experience in breast augmentation using implants.
Third, while the patients must always choose from the products approved by FDA, there is very little additional advice (beyond FDA announcements & published materials) that they may get from the regulatory authorities.
Fourth, the patients must have a good cosmetic surgeon – they must select from the cosmetic surgeons who have long and hands-on experience in breast enhancement procedures and handling patients.
The patients should seek out the cosmetic surgeons who use safe techniques of breast augmentation using reliable implants and not any other implant, allow the patients to choose from different types and size of implants as per their desire.
The patients should ascertain that maintaining their safety and meeting their goals are the two most important conditions that the surgeon they choose, will be able to meet.
There have been several advances in techniques in cosmetic surgery including anaesthesia procedures. Some of the leading surgeons, who keep abreast with the advances, can bring in these latest and safe developments for the patients’ benefit.
One such example is safe “Awake” procedure in which the patient is under local anaesthesia remaining awake through the breast procedure. Tumescent fluid is used which also decreases risks of bleeding, infection, and potential general anesthetic risks. Plus, she can take part in deciding on the final shape and size of the breast.
So, there are a number of conditions for a patient to check, before choosing a cosmetic surgeon and going ahead with the procedure like breast augmentation. A good cosmetic surgeon fulfilling these conditions and backed by good infrastructure and good staff should be the one to be entrusted with the cosmetic procedure by the patient.
[Source: This write up is partly sourced from the article “UK regulator criticized over implant scandal” Publish date: May 31, 2012 By: Paul Gillette Source: Cosmetic Surgery Times E-News]