How Long Till The FDA Approves Silicone  Implants? 

The approval process of FDA has had more or less a positive or near positive history with regard to silicone  implants.  implants for the first time in history started selling in the market way back in the 1960s. The FDA at that point in time did not have any regulatory body, which could have regulated the entire mechanism of selling the brand in the market. Thus, between the 1960s and 1970s,  implants sold like hot cakes in the market, and the product caught the attention of particularly those women, who were not at all satisfied with the size of their s.  At the very outset, they were not that concerned about the consequences of the silicone  implants they were going to use for  augmentation.  They at any cost wanted to beauty their s to the best possible extent.

Since at that time, the FDA did not have any kind of regulatory body, the public went on an implant-purchasing spree. The greatest benefits if any one got was most prominently the manufacturing companies. They were the ones who were accountable as to what actually they manufactured for the consumers. With no regulatory body to control their activities, the implant companies made huge profits without standardizing their product. Women, who used these implants to look beautiful and attractive, did not care either. The race to look attractive made women ignore many of the consequences. Working women had their own priorities and wanted to look presentable at office. High-society women, who socialized a lot, wanted to corner all the attention at parties and social dos.

Sales of Silicone  Implants Were Slow Between 1960s and 1976

However, between the 1960s and 1976 the use of the silicone  implants was a bit slow. Possibly, it could have been due to lack of awareness or some other specific reason, not clarified officially. One possible factor could also be said to be the doubts generated around the implants by certain vested interests in the market, leading to the decline in the business of implants in the market. Certain lobbyists, who were against  implants, built public opinion against the product by sowing doubts in the mind of the people. This propaganda had an impact on the FDA as well.

By 1990, Almost One Million Women Had  Implants

The real boom in  implants came in the 1990s. The implants sold in the market like hotcakes. The women section of the society were not overly concerned about the safety factors that they needed to adopt, while going for  implants for enlargement or reconstruction purposes. They were ready to pay any price for making their figures look attractive and beautiful. The negative side of  implants came to light when complaints started pouring in from all quarters. This made the government authorities to sit up and take note. Before any appropriate measures could be adopted by the authorities, a large number of women had already undergone  implants.  implants were considered a great invention and a dream come true for every woman. These large-scale implants were a cause worry for the authorities and the women who had undergone the surgery. In due course of time,  implants were exposed as having more side effects than benefits. 

In 1991, the FDA made it mandatory for the manufacturers of Silicone Gel  Implants to submit safety devices

When the silicone  implant problem reached alarming proportions, the government had to intervene. The FDA made it mandatory for the manufacturing authorities to come out with complete guidelines regarding the safety norms of implants, stating as to which kinds of manufactured implants were safe for use. Unless this was done, the FDA authorities were not ready to approve the product in the market for consumption purposes. Meanwhile, a lot of controversy arose in the industry on the use of silicone-gel  implants. The Mentor and MacGhan (Inamed), the two important companies in particular, and other companies in general were strictly instructed to adopt safety norms to avoid any kind of complaints regarding the implants they were supplying in the market for the consumers.

 The FDA required studies of local complications

The FDA further asked for details regarding the local repercussions such as infection, hardening, pain and the requirement of additional surgery following the  implants. In the guidelines issued clearly, it was instructed that come what may, the manufacturing company had to ensure the safety norms regarding the use of its product in the market. In the absence of this, the regulating authority decided to put a ban on these products in the larger interest of the country in general and the women section in particular.

In 2003, “A new, Safer Silicone Gel  Implant” attracted considerable Media Coverage

The conditional approval that FDA gave attracted considerable media coverage. It was a go-ahead signal from the authorities and it was lapped up by women as they went on a  implant-buying spree. The implants that made it to the market were improved products as the manufacturing companies had invested a lot in research. This step paved the way for women to adopt these implants without much concern except that they had to take a little precaution like consulting the doctor before going for the implants. They were also advised to consult the doctor after the  implant surgery to avoid any unforeseen complications.

Role of Silicone  Implants in  Reconstruction

How Far Along is the Approval Process of the FDA?

The Role of the Manufacturer (Mentor) Working on the Project of Implants

Reasons for  Implant Surgery

Types of  Implants

 Surgery Procedure and Techniques

Price of Silicone  Implants

Silicone  Implants and Cosmetic Use

Application of the New Silicone  Implants for  Cancer Victims

Issues Associated With Silicone  Implants

The Role of New Technology in Making People Safer With Silicone  Implants

Living With  Implants

Surgery Complications

Effects on Pregnancy, Lactation, and Children

 Enlargement and Public Opinion

Removal and Replacement of Silicone  Implants

Deciding for a Better Future With Silicone  Implants

Mentor and  Implants

Silicone  Implants and Mammography

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Information and opinions provided here are never to be construed as medical advice.   Readers should consult appropriate health professionals on any matter relating to their health.