Breast Implants, PIP Breast Implants & Anaplastic Large Cell Lymphoma (ALCL): A Rare form of Non-Hodgkins Lymphoma (Nhl).
A Scientific Guide for patients.
Many patients in Australia and across the world have recently become aware of the risks associated with a specific make of Breast Implant, called Poly Implant Prosthese (PIP).
Dr. Bobby Kumar (Cosmetic Surgeon) has never used PIP Breast Implants. He has chosen only to use breast Implants with a proven and trusted safety record, and breast Implants that are recognised and approved by the major medical authorities around the world, such as FDA (Food and drug authority of the US), TGA and NHMRC of Australia as well as UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Breast Implants that are recommended at the Bare Aesthetics Cosmetic clinics and by Dr. Bobby Kumar are Eurosilicone (It has one of the lowest rates of all breast Implants for rupture), and for specific cases Polyurethane (“Furry Brazilian” or P-URE) and Mentor Breast Implants. These Implant companies provide guarantees for their Implants; Eurosilicone Implants are Insured for life to all my patients and the company will exchange for free any on their Implants that develop a spontaneous rupture and or capsular contracture.
Bare Aesthetics Cosmetic Surgery Clinics has received many enquiries regarding what to do from patients having had PIP breast Implants by another surgeon.
Dr. Bobby Kumar (Cosmetic Surgeon) in his opinion has recommended that the PIP Implants be removed especially if they have ruptured; this is contrary to the recent advice provided by the TGA and their advisors.
1. So what are the issues with the PIP breast Implants?
The media and the PIP manufacturing company have released a statement suggesting that PIP Implants have a higher than expected spontaneous rupture rate, at least approximately 4x greater than other types of breast Implants. There is a greater risk of Capsular Contracture and now a suggestion that this particular breast Implant is implicated in the formation of a rare form of NHL tumour (ALCL) of the scar tissue(Capsule) surrounding the Implant.
Of particular concern are textured PIP breast Implants as well as textured titanium coated breast Implants.
Consequently Poly Implant Prosthese(PIP)has advised that patients should consider removal of their PIP breast Implants.
This has caused significant concern amongst patients with PIP Implants or in fact with any breast Implant, as evidenced by the number of calls received at Bare Aesthetics Cosmetic Surgery Clinics. In Australia PIP breast Implants were used largely by Surgeons in South Australia (State where the parent Importing Company of PIP breast Implants resided) and Queensland.
PIP breast Implants were banned for use in Breast Augmentation in the USA by the FDA in the year 2000 when it became evident that there were significant spontaneous rupture rates and capsular contractures. It was also recognised that PIP manufacturing company were using Industrial strength Silicone, not authorised or appropriate for use in medical breast augmentation.
Despite the FDA findings the Australian TGA only banned PIP breast Implants in approximately 2010, when similar concerns were raised by Australian patients reporting adverse outcomes.
2. What are the concerns regarding Breast Implants and the rare ALCL tumour?
Depending on the source of scientific literature and information there are a slightly varying number of ALCL cases in women having undergone breast Implantation.
After a careful review of literature published from January 1997 through May 2010, the FDA identified 34(one study identified only 27) unique cases of ALCL in women with breast implants worldwide. In addition, the FDA has received information from other international regulatory agencies, scientific experts and breast implant manufacturers. Altogether, the agency is aware of approximately 60 cases of ALCL in women with breast implants. Most of these women are mainly in Europe and some in the USA.
However, based on all the evidence available to us at this time, the FDA believes that women with certain types of breast implants may have a very low but increased risk of developing ALCL.
The true cause of ALCL in women with breast Implants is not certain; therefore there is no established causal relationship between breast Implants and ALCL.
3. What is Anaplastic Large Cell Lymphoma (ALCL)?
ALCL is not breast cancer. According to the National Cancer Institute (USA), ALCL is a rare malignant tumor (non-Hodgkin lymphoma) that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs or liver.
Also according to the National Cancer Institute, an estimated 1 in 500,000 women per year in the U.S. are diagnosed with ALCL. ALCL in the breast is even rarer. Approximately 3 in 100 million women per year in the U.S. are diagnosed with ALCL in the breast (with or without breast Implants).
Even though ALCL has been found in the breasts of some women with breast implants, it is not breast cancer. ALCL is a type of lymphoma, a cancer of the cells of the immune system.
In fact the type of ALCL that forms in association with some breast Implants, that is, ALCL Kinase negative, is an even rarer form of all the subtypes of ALCL.
ALCL comprises only 2% of all newly diagnosed NHL worldwide. Lymphomas occurring in the breast are even rarer, comprising only 0.04 to 0.5% of all breast cancers and approximately 1-2% of all extranodal (outside of lymph nodes) lymphomas.
The absolute risk of developing ALCL following breast augmentation is extremely small. It is estimated by de Jong et al. to have an incidence of 0.1 to 0.3 per 100,000 women with breast Implants per year.
Following an expert multidisciplinary panel in the USA early last year (2011) regarding ALCL and breast Implants; a proposed aetiological cause is repeated Microtrauma to breast Implant surface via degradation of the Implant surface. This leads to silicone particles to come in contact with native tissue, the silicone particles are taken up by the breasts inflammatory cells. The fibrous capsule surrounding the breast Implant becomes disrupted, causing a re-initiation of the Immune system response and potentially leading to the development of ALCL through a chronic inflammatory reaction.
This is the same mechanism proposed or thought to occur with PIP breast Implants and the potential risk of developing ALCL.
4. Symptoms associated with development of ALCL and women with Breast Implants
The main symptoms of ALCL in women with breast implants were persistent swelling or pain in the vicinity of the breast implant. These symptoms were noted to occur well after the surgical incision had healed, often years after implant placement (published articles estimate 6 months to several years after breast augmentation).
Upon evaluation, evidence of fluid collection around the breast implant (seroma) was observed. Some patient reports indicated that a palpable mass or capsular contracture (thick and noticeable scar capsule around the implant) were present.
5. Where in the breast has ALCL been found in women with breast implants?
In the case studies reported in the literature, the ALCL was found near the breast implant, and contained within the fibrous scar capsule. However, it was not in the breast tissue itself. The illustration below shows the location of the ALCL in these reports. In most cases, the ALCL cells were found in the effusion fluid (seroma) surrounding the implant or contained within the fibrous scar capsule.
ALCL disease occurring in women with breast Implants is a clinically indolent disease with a favourable prognosis, as distinct from the systemic ALCL disease type.
Management consists of removal of the involved breast Implant and capsule, which likely on current evidence will prevent local reoccurrence (evaluation for other disease sites needs to be performed).
With capsule confined disease, adjuvant chemotherapy and radiotherapy is not required.
Whilst ALCL of the breast and in particular in women with breast Implants is rare, it is believed that there is a positive association between ALCL and breast Implants. There is NO causal link at this stage between breast Implants and ALCL.
However, some scientists now suggest that textured breast Implants (such as PIP breast Implants) are a potential cause for developing ALCL through microtrauma of the Implant surface and chronic inflammation of the scar or fibrous capsule, or capsular contracture formation.
The scientists have suggested that smooth breast Implant surfaces potentially have a lower or no risk of developing ALCL. It is uncertain whether Polyurethane breast Implants are better than textured silicone breast Implants.
The expert panel also believes that there is evidence of an increased risk of developing ALCL in women that have breast augmentation in the Subglandular plane (under the breast) compared to those women with Subpectoral breast augmentation (under the pectoral muscle).
The treatment is removal of the breast Implant and fibrous capsule. It is not clear whether there is still a long term risk of developing ALCL despite removal of the affected breast Implant and capsule.
To reiterate Bare Aesthetics Cosmetic Surgery Clinics and Dr. Bobby Kumar have received many enquiries regarding what to do from patients having had PIP breast Implants by another surgeon. Dr. Bobby Kumar (Cosmetic Surgeon) in his opinion has recommended that the PIP Implants be removed especially if they have ruptured; this is contrary to the recent TGA advice.
Patients with PIP breast Implants are naturally distressed and anxious about developing ALCL and removal of the affected breast Implants which then entails increased risk or morbidity of having further surgery and anaesthesia, especially as it will take longer than a standard breast augmentation. Also there is consideration of cost; it is unclear who will finance further surgery for the removal of the affected PIP Implants.
At this stage patients are expected to finance further surgery, although international authorities are suggesting the government finance patients in cases where breast augmentation with PIP Implants followed corrective surgery for breast cancer; or it be financed by the private clinics and or Surgeons that performed the breast augmentation with PIP breast Implants.
Dr. Bobby Kumar is a board certified Cosmetic Surgeon, experienced and qualified to perform Breast Augmentation or Breast Enlargement surgery. For advice regarding Breast Implants and PIP Implant related issues, please contact us at www.bareaesthetics.com.au or call (02) 9571 4850 or 0430 491 009.
Written by Dr. Bobby Arun Kumar on Wednesday the 11th of January, 2012. Currently No Comments »
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