PIP Implants Investigated

By: Mr Umar Khan
Created on 15th January 2012

Cosmetic surgery forums in the UK have been buzzing since the recall of PIP implants by the French medical authorities. Thought to have been used in up to 50,000 breast augmentation procedures in the UK, PIP implants contained a non-approved silicone gel and had a high rupture rate leading to complications. Leading plastic and reconstructive surgeon Mr Umar Khan of re-shape comments on the controversy

At the end of March of this year the Medicines and Health Products Regulatory Agency (MHRA) in the UK issued an alert about gel filled breast implants manufactured by French company Poly Implant Perthese (PIP), after the French medical authorities carried out the an inspection of the PIP manufacturing plant and established that the most of the implants manufactured by the company since 2001 have been filled with a silicone gel with a composition different from what had been previously approved.

When I received the press release from MHRA, I was so relieved that these implants were not going to be available for implantation and no women would have to go through the problems which arose from these implants. But obviously thousands of these devices have been implanted and the news has generated panic in patients; as a surgeon I have been answering queries on daily basis since then.

I think the news was long awaited as the surgeon and patient experience with the PIP implant was extremely poor with an unusual number of complication rates. Most common being the rupture of implants within two or three years of their insertion and quite often these patients were presenting with lumps or siliconomas.

As a surgeon I used these implants in 294 patients between April 2003 and October 2004. The reason I stopped using these implants was not its rupture but the feel of the device once it was implanted. These implants always used to feel like hard discs inside a breast and quite often could be seen from outside as a round line. However, for many the implants seemed to be a good choice as it seemed very cost effective compared to other implants.

In 2004 and 2005, I started seeing patients who’d been treated by other surgeons with complaints of breast autoinflation and lumps in the armpit and breasts. The patients with lumps were often seen by their GPs for possible breast cancer and after a full screen were referred to me for further management.

The ultrasound and mammogram of these patients showed ruptured implants with thick fluid in and around the prosthesis. Ultrasound imaging also showed silicone lumps in the breast and, in some cases, the lumps were much widely spread out into the armpits.

When these patients were operated on, almost all showed ruptured implants with a very thick creamy fluid which I have named sterile pus. The samples were sent to laboratories and none grew any bacteria on tests. I treated these patients with implant removal, breast clean up with saline and antibiotic irrigation, and new implants were inserted at the same time in one single operation.

Silicone lumps were removed at the same time, when present, and in one of the patients a massive lump (siliconoma) was removed from within the breast implant pocket to avoid extra scarring on the chest wall. Quite often, I used to change the implant pocket by putting them into a muscle splitting pocket, a technique I pioneered.

Ruptured implants were sent to the implant manufacturer but none were reported as defective. All reports came back as normal with references quoting possibility of implant rupture as early as one or two years.

I started writing articles about my experience with PIP implants, three of which were published in journals in the US (these articles can be available on request). After the secondary operations, I followed the patients for at least a year and these patients had no untoward health problems.

One of the patients that I operated upon did develop a moderate capsular contracture and also has noticed a recurrent lump, in the armpit, on the previously ruptured implant side. She has been recently seen by me and is interested in getting the lump removed with some corrective surgery for capsular contracture.

The problem of lumps is that they can be recurrent because the leaked defective silicone may continue to travel through the lymph channel and may present as lumps at different time.

As a surgeon, we have a lot of responsibility when we treat a patient and that includes acknowledgment of our limitations, to choose a right and a safe option and, last but not least, to select a safe and approved product. However, the problem arises when products have all the required checks and approval. As a member of the surgical community, we have to be vigilant and any unusual outcome and complication should be logged in and reported. Use of a good quality product is mandatory once the patient has put a trust in us.