NARELA, with its narrow bulges are an industrial neighborhood, the north-west outskirts of Delhi, the unlikeliest of places to house a clinic that conducts breast implant surgeries. But it is here, on the first floor of a building, that K D Plastic & Cosmetic Surgery Center has an operation theater and a patient ward. And thriving, if you ask the center's manager who admits that breast implant surgeries are conducted here for around Rs 50,000 each.
In Pitampura, 20 km from K D Plastic Surgery Center, is Olmec Plastic Surgery Center. Here, the operation is in the Delhi Development Authority (DDA) flat. It appears to be a busy center that the waiting period for a breast implant surgery is here two months. Commonly the two centers He worked on the Olmec Plastic Surgery Center. Realizing how breast implants are great demand, and the surgery is lucrative. He now owns the K D Plastic Surgery Center in Narela. What are his medical degrees? Is his clinic certified to do these surgeries? Is there a way to check his track record? Are there peers who testify to their competence? Is he a quack with a scalpel?
Each is a valid, potentially life-and-death question.
Because, nothing more powerfully illustrates what's wrong with the medical device market in India than the boom in India's breast surgery market. No one is checking Regulators do not exist; technicians often double up as surgeons; shame and stigma prevent patients from reporting the gruesome aftermath of what has gone wrong, an investigation by The Indian Express has found. On Monday, The Indian Express, in collaboration with the International Consortium of Investigative Journalists (ICIJ), reported how almost every medical device is advertised, sold and surgically regulatory in the implanted system that is now only up to a constant stream of wake up reports from across the country From coronary stents and pacemakers to breast and knee implants, from pelvic meshes to intrauterine devices.
And how global majors lured doctors with freebies to push their products, and persuaded patients to cough up "exorbitant prices" for implants with aggressive marketing and attractive loan schemes
'There is quackery all around'
In Pitampura, Dr. Narendra Kaushik, who owns the Olmec Plastic Surgery Center, says almost half of all breast implants he carries out "revision surgeries". He has maintained a record of some of these surgeries and the video clips he shares make a chilling, horrific tale of the callous, unregulated manner in which breast implant surgeries are conducted.
One video record It has fragmented and has symptoms of infection. Another implant removed from a patient shows a collection of mites on the surface, proof that the original surgery was done under extremely unhygienic conditions. A third case Dr. Kaushik mentions the removal of a prosthesis from a breast – this is what a surgeon has placed instead of the usual silicone or saline implant, which has been sold in hundreds of years.
Dr. Kaushik says he performs 10-15 breast implant surgeries in his Pitampura clinic, maybe half of those on transgender patients. "A majority of revision surgeries or correction surgeries are being done not because of faulty implants. They are being done because non-qualified people are performing the surgeries and because the implants themselves are accessible for anyone to buy. In the last five years, breast implant surgeries in India have gone up exponentially and I even notice a trend in my clinic of boyfriends sponsoring surgeries for their girlfriends. The problem: there is quackery all around, "he says.
And far from Pitampura, at a clinic in Saket that caters to the more affluent, the breast implant surgery is different. This clinic in South Delhi is owned by Dr. Monisha Kapoor and she, too, says that of 10 breast implant surgeries she conducts, at least five are corrective surgeries. "We are correcting more and more breast implant surgeries and many patients have come waterfall or capsule deformities. People are being duped because today also dermatologists and ayurvedic doctors are performing surgeries with questionable standards in clinics mushrooming all over the city and the country, "says Dr. Kapoor.
A patient who did not want her identity revealed that she had got her breast implants done at a Greater Kailash-II clinic by a well-known plastic surgeon. Evidently, it was a hurried job for which she had paid Rs 1.5 lakh. Later, she approached Dr. Kapoor for the repair job.
"The implant had obviously not been put in the right place and even my husband The implant becomes lumpy, soon after the shape of a capsule To make matters worse Once I was opened to the Saket clinic for the revision surgery, I was shocked to see the collection of pus. Severe infection that had set in, '' the patient told The Indian Express
No scientific study in India
While no scientific study has been conducted in India on the side-effects or risks of breast implant surgeries The world over, implants are used for either size augmentation or reconstruction of the breast after mastectomy or any other damage to the breast. A third category has now been added – that of "revision surgery" for correction of the original breast implant surgery.
It was 2006 in the US Food and Drug Administration (FDA) approved sale of silicone implants of companies like Allergan and Mentor, saying there was no direct link between the implantation and cancer. But it made it to the companies that entered into an adverse event summary reporting program with them. Currently, the FDA mentions capsular contracture, breast pain, rupture with deflation and silent rupturing as some of "complications and adverse outcomes" of breast implants. More than a decade after the 2006 FDA report, studies (from 2013 to 2017) have concluded that there is an association between breast implants and systemic illness. Significantly, the FDA's current page on the risks of breast implants found that it has not detected any association with systemic
"but in order to rule out these and other complications, studies have needed to be larger and longer than those conducted so far …"
A study by the ICIJ as part of the Implant Files investigation shows that as far as the US FDA's Manufacturer and User Facility Device Experience (MAUDE), the breast implants are concerned, the past two years in adverse reports in a rise. MAUDE is a database which houses medical device reports submitted to the FDA.
Data on breast implants show that from 408 adverse event reports in 2006, the number got up to 4,756 in 2017. And until June of 2018, the number had climbed to 8,371 Figures put out by the International Society of Aesthetic Plastic Surgery, show that India ranks seventh among the top ten countries in 2016 for the total breast procedures, which include saline implants, breast lifts and reductions as well as breast implant removals. The total number of breast procedures recorded for India was 92,960.
No list of manufacturers
While international health advisories on sale of breast implants remain vague, this is one area which is largely unregulated in India. The Central Drugs Standard Control Organization (CDSCO) maintains no list of licensed Indian or foreign manufacturers who have put their implants on the shelf in India.
Top distributors say both Mentor and Allergan stopped distributing in India due to poor sales. Two companies currently distributing are Motiva and Eurosilicone and they together account for around 1,000 pairs of breast implants annually. Then, there is a huge quantum of "gray area" sales with Chinese and Korean products flooding the market.
AD Mathur, Director of Myovatec Surgical Systems Pvt Ltd, the distributor for Motiva implants, says: "I have been dealing in breast implants since 1984 and can say that the business is growing, but very slowly." Namita Kumar, who heads Bengaluru -based Apex Marketing which distributes Eurosilicone implants, says: "We have been dealing with breast implants since over two decades and in the first year, we sell just one pair. Now we are doing 500 pairs a year and there is definite spurt in sales. Implants are now being gifted as Valentine's Day gifts, but the problem is also even dermatologists and gynaecologists are performing surgeries. Guidelines need to be tightened urgently. "
Several prominent plastic surgeons have told The Indian Express that they have taken the subject of only members of their fraternity performing surgeries with their All-India associations but no formal guidelines issued. Dr. Manoj Khanna, Chairman of Enhance Clinics and President of India Association of Aesthetic Plastic Surgeons, says: "We have taken this subject but at present, there is no legislation to prevent any surgery from breast implantation."