Implant Files: Inside the Murky Breast Implant Industry

Severe faults in the breast implant industry are being revealed worldwide and from investigations in India.

Different investigations into the breast implant industry have revealed the unacknlowdged harmful consequences of the surgery. 

(Photo: iStockphoto)

More than 10 million women have received breast implants worldwide. As part of the Implant Files series, a report by the International Consortium of Investigative Journalism has revealed the ignorance and unaccountability that characterises the breast implant industry. The investigation also showed the grave consequences that it can lead to for women who have undergone such surgeries.

As per the Food and Drug Association’s (FDA) safety notices, around one in every five women who receive breast implants will get them removed within a decade due to complications such as rupture, deflation and the painful contraction of scar tissue around the implant, known as capsular contracture.

An investigation by The Guardian showed that in the UK, 1459 reports of incidents related to breast implants have been recorded in the last three years, more than 1200 of which were serious. These cases were revealed through a Freedom of Information (FoI) request to the Medicines and Healthcare Products Regulatory Agency (MHRA) and mostly dealt with implants that had caused allergic reactions, pain, psychological problems and the need for another operation.

While the data could not explain the causes of the problem, it did uncover some of the harmful results that breast implants might lead to.

One-third of the reports involved ‘material separation’ (rupture in the shell or he inside of the implant) and a quarter involved a leak. Fifty-seven women experienced anaplastic large cell lymphoma (ALCL), a lymphoma that can significantly affect the immune system. As a result, women were forced to have their implants removed and replaced.

Similar problems in other countries have been collated in the ICIJ report.

For instance, a study in the US showed links between breast implants, rare illnesses that affect the immune system, and others like the Sjögren’s syndrome, characterised by dry mouth and eyes. The results were obtained from findings of the leading implant manufacturers, Allergan and Mentor, where many women also expressed satisfaction with the implants.

Amy Rose, Allergan’s Director of Media Relations, shared the other side with ICIJ, “The safety profile of Allergan’s breast implants is supported by extensive pre-clinical device testing, more than a decade of US and European clinical use as well as a large number of peer-reviewed and published studies.”

The report put a part of the blame on regulators for not penalising manufacturers who violate government regulations or provide flawed data on implant safety. For instance, in the European Union, authorities allowed 10 companies that sell implants in member countries to continue operating even when half failed to provide clear instructions or caution. Similar cases have been quoted from the US, Canada and Brazil.

Patients Kept in the Dark

Many of the women who get implants are not informed about the short-term and long-term consequences. (Photo: iStockphoto)

The research revealed horrifying numbers for the level of awareness regarding implant complications.

Over 300 people who responded to an ICIJ survey said they were unaware of the long-term dangers of breast implants before undergoing the surgery. Only two conceded to have been warned about the local complications, but still not long-term risks. 40 percent women said they did not receive any warning at all.

A Look at Delhi Clinics

Indian Express investigated some Delhi clinics to highlight the conditions in which implant surgeries are performed. (Photo: iStockphoto)

Investigations by Ritu Sarin from the Indian Express into Narela’s K D Plastic & Cosmetic Surgery Centre and Pitampura’s Olmec Plastic Surgery Centre led to some startling revelations about the state of implant surgeries in the city.

No one is checking the implants for safety; 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,

Upon going through a few video clips maintained by Dr Narendra Kaushik, owner of the Olmec Plastic Surgery Centre, the investigations could clearly see the poor state of implant surgeries in Delhi. For instance, an implant removed from a patient showed a collection of mites on the surface, indicating the unhygienic conditions of the original story.

Notably, the Central Drugs Standard Control Organisation (CDSCO) maintains no list of licensed Indian or international manufacturers which sell their implants in India. This is considered as a major flaw in the functioning of the industry, as the report suggests.

(With inputs from ICIJ and Indian Express)