Fw: Booby trap : Foreign companies dump poor quality

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http://www.the-week.com/23jan26/life9.htm

Jan 26, 2003

Booby trap Foreign companies dump poor quality breast implants in India

By Nistula Hebbar

Though breast implants provide a psychological boost to women who undergo mastectomy, the surgery has not been able to shake off its cosmetic image. This may be the reason why there are no specific standards in India for grading implants.

India's market for breast implants may be small at Rs 15 crore but it is growing. "Implants in India come from companies in Europe or the US," says Dr S.B. Gogia, one of Delhi's busiest plastic surgeons. The main players are Laboratoires Eurosilicone, Silimet and Nagor in Europe and McGhan of the US, which operate through local agencies.

Quality matters: A damaged implant with silicon oozing out

Though nearly 200 implants take place a month in Delhi alone, both the Bureau of Indian Standards and the Drug Controller General of India's office admit that there are no rules of certification for the prostheses. The certifying bodies accept the ISO series and the European Union's CE mark as benchmarks of quality.

Patients or doctors have no recourse to law in case of problems with implants. Gogia recalls a surgery where one of a pair of implants burst and the silicone oozed out. "Luckily this happened before it was implanted," he says. "Silimet refused to take back the damaged product and I had to replace it with a Nagor implant and bankroll the entire switch."

This was not the first time that customers have complained about Silimet, which does not have the CE certification and has allegedly shifted base to Brazil from France. Virender Sethi, marketing agent for Silimet, does not deny that the company has no certification. He, however, claims that it is the only company outside the US to be approved by the US Food and Drug Administration. "I don't know why the company has shifted base to Brazil," he says. "As of now, only we sell really affordable implants and we are quite popular."

It is not that doctors are unaware of the issue. "We have received several complaints about Silimet, but the price difference between its product and those of other companies makes it attractive," says one south Delhi plastic surgeon. Silimet implants are priced between Rs 2,000 and Rs 10,000, Nagor implants between Rs 24,000 and Rs 31,000 and Laboratoires Eurosilicone implants between Rs 16,000 and Rs 23,000. An entire batch of implants was recalled in November 2001, when it was found that Eurosilicone had been resterilising some of themÑa practice frowned upon by European Union standards.

"I have had problems of discharge from Eurosilicone implants, but I cannot comment on it in general," says Dr Lokesh of Apollo Hospital, Delhi. But Kumar, head of Eurosilicone's Bangalore-based agent, Apex Marketing, defends the company. "We have CE certification, it is Silimet which does not have one," he says. "We have in fact written to the ministry of health to evolve some standards for the industry."

As of now the companies are required to keep an international register where the serial numbers of implants sold along with the customer's name are entered. However, Deepak Sapra, head of Nagor's agent, Technomed India, says that safe practices are seldom followed in India. "We have an information booklet with an approval form to be filled by the clients," he says. "I hardly get it back. Since there are no standards and those who get implants do so in secrecy, there is hardly any danger of being caught."

Not always an asset A breast implant might cause complications. Most often, correction involves surgery. Capsular contraction: As the body heals after surgery, the implant gets covered by a capsule of fibrous tissue. Usually soft and yielding, such capsules occasionally thicken and contract downwards resulting in firmness, discomfort or occasional pain in the breast. It can also affect the shape of the breast.

Infection: Infection usually occurs shortly after surgery. Symptoms include redness of skin, tenderness, swelling of the breast, pain and high temperature. In some cases the implant may have to be removed.

Folding: Gel implants fold if the surgical pocket is too small or there is extreme capsular contraction.

Displacement: Soon after surgery, implants may move slightly. It can be corrected through surgery.

Deflation: The implant may deflate, or the fluid may flow out. Correction involves replacing the implant.

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