History of breast augmentation surgery

History of breast augmentation

The history of breast augmentation and its regulation is starring the manufacturers of these devices and the Food and Drug Administration of the United States (FDA for its acronym in English). But there are other ‘actors’ in this story such as legal experts, the media, Wall Street, public interest groups, Congress and undoubtedly medical specialists in plastic surgery.

1895-1975

breast augmentation history
In 1895 was recorded the first description of a breast augmentation surgery

Since 1895, when Czerny, a surgeon from the Czech Republic, recorded the first description of a breast augmentation surgery, a number of techniques have been tried to satisfy the wishes of women either to increase or to reconstruct their breasts. Among these efforts we can mention injections of paraffin wax and silicone free in the 20th century, a disastrous practice that led to numerous problems of leakage or migration and embolization, with the consequent formation of granulomas in the chest.

We should also mention the placement of sponges made of plastic polymers, a technique that was discarded due to the numerous problems with infections, contractures and tissue growth, which prevented future prosthesis removal.

The history of breast augmentation and its regulation is starring the manufacturers of these devices and the FDA.

It was in 1962 when surgeons Cronin and Gerow managed to implant a device containing silicone gel inside a silicone elastomer coating and the patient who received it was Timmie Jean Lindsay. This prototype is considered the precursor to breast implant surgery and was commercially manufactured by Dow Corning in 1963 and the product was exempt from the FDA regulations, as it was considered a medical device and not a medicine.

1976-1990

history of breast augmentation
In 1962, surgeons Cronin and Gerow managed to implant a device containing silicone gel inside a silicone elastomer coating

In 1976, with reforms to the Safe Medical Devices Act made by the United States Congress, breast prostheses are no longer exempt from regulation by the FDA. Despite the recommendation initially given by the FDA’s General and Plastic Surgery Devices Advisory Panel that the implants were considered products of class II, i.e. they were subject to general controls, in 1982 the FDA took the legal decision and proposed the classification of these products as Class III, i.e. subordinate to the demonstration of safety and effectiveness before entering the market.

At the same time, surgeons and patients began to discover the excellent long-term results of breast augmentation surgery with the new generation of breast implants.

Bad experiences with capsular contracture caused numerous reoperations that led to reveal a rupture rate of implants was not expected to be so high. There were lots of dissatisfied patients with breast prosthesis failure, who expressed the need to be operated again. Some expressed it by legal means and the first lawsuit was filed in 1977, in which a woman from Cleveland, whose implants had ruptured, received a compensation of $ 170,000 for pain and suffering caused by having to undergo surgery again in order to remove the implants.

Later in 1984, another case against Dow Corning was presented, this lawsuit was filed on the basis of a misinterpretation of data from internal studies of the Dow Company and the patient received a compensation of $ 1.7 million. This case caught the attention of the media especially because of questioning the safety of implants.

In 1976, with reforms to the Safe Medical Devices Act made by the United States Congress, breast prostheses are no longer exempt from regulation by the FDA.

Growing dissatisfaction of plastic surgeons with gel filtration and implant failure, fostered greater cooperation with manufacturers in order to improve the design of the prosthesis, make covers more durable and therefore cause a decrease in rupture and leak rates.

The production and supply of information required by the FDA was a challenge and efforts to meet this challenge were limited by the slow production of the devices and the resistance of the manufacturers to assume the new classification of the FDA because they did not want to accept that the availability of these devices could be restricted.

1990-1999

breast enlargement history
The final regulation for breast implants was published in 1991 by the FDA

The final regulation for breast implants was published in 1991 by the FDA and this legislation established that the manufacturers of these products had 90 days to submit requests for pre-market approval to show that the products are safe and effective, as a guarantee prior to their manufacture and distribution.

Manufacturers like McGhan and Mentor, who had anticipated this regulation and seen the need to generate this data, began their studies one year before this regulation entered into force and completed their reports before the deadline, July 11, 1991. The General Assembly and the FDA’s Plastic Surgery Devices Advisory Panel scheduled for November 1991, would review the available information and then recommend a course of action, the American Society of Plastic and Reconstructive Surgeons (ASPS) for what they formed a working group dedicated to the study of silicone implants.

The purpose of this group was the independent review of the evidence for and against these devices and to use this information to contribute to effective public education. This group reviewed the results of research available until then and it began to be clear that the problems associated with silicone implants were mostly local, muscle-skeletal problems, associated with rupture and capsular contracture and there was no evidence to support an association between silicone implants and systemic disease.

There was no evidence to support an association between silicone implants and systemic disease.

The meeting of the FDA’s advisory panel took place from 12 to 14 November 1991. A thorough review of the data was done and coincided with the analysis done by the working group of the ASRPS, and therefore the panel unanimously voted for the implants to remain on the market in order to contribute to public health of women who undergo breast reconstruction.

breast augmentation history
There is no link between implants and connective tissue diseases

From April 1992 the phase in the history of implants was marked with the lifting of the moratorium on the implants and was characterized by the abundance of litigation.

The transition to the next stage of this history is marked by several symbolic judicial decisions. Due to the large number of lawsuits that patients filed against manufacturers of silicone implants in the United States, the judicial authorities saw the need for strong and objective data to give a verdict.

It was in April 1996 when two federal judges in New York City named an independent and impartial panel of experts to review the available literature on these devices and their medical effects. This decision was of vital importance as it did not only help judges to resolve cases involving implants, but it also set a precedent in regard to validation of medical examinations.

In 1999, the year in which the Institute of Medicine of the National Academy of Sciences issued a report on silicone implants, in response to a request from Congress for a conclusive review of the evidence generated until then, found no link between implants and connective tissue diseases or that the implants could cause cancer, neurological diseases, childhood diseases or interference with cancer treatment. The media spread these findings.

2000-Present

breast augmentation history
You should inform your doctor if you develop unusual symptoms such as asymmetry, hardness, swelling and pain

The year 2000 was the beginning of the time when the doubts regarding breast implants were clarified. The manufacturer Inamed (formerly McGhan) and Mentor in May 2000 received the approval of their permanent means of access to saline- filled implants.

As international literature on implants was being produced, it was clear that the problems with the implants are not systemic, but local and they mainly originate from capsular contracture, rupture and new surgical interventions.

In May 2000, the US FDA, inspected the PIP production site in southern France. As a result this brand of breast implants was banned in the United States. In a letter to Jean Claude Mas, owner of the company, the FDA warned that the implants were defective and determined other deviations from correct manufacturing practices, including the lack of sufficient studies of the rate of deflation and lack of reporting 120 complaints that had been brought to this brand. These prostheses were banned worldwide.

Patients with breast implants should continue going to their regular breast screenings for early detection of breast cancer.

Years after the second period of moratorium, in November 2006, the FDA approved Allergan (formerly Inamed) and Mentor to continue the manufacture and marketing of breast implants filled with silicone gel for widespread use in the United States, including indications for cosmetic and reconstructive surgery.

breast augmentation history
You mast keep regular follow-up visits.

Among the results of this excellent investigation that led to this approval, the process of informed consent was obtained, as well as implants, surgical techniques and methods to ensure the responsible monitoring.

In late 2011, the scandal of PIP implants was known well known and among the recommendations made by the International Confederation of Plastic Reconstructive and Aesthetic was the replacement of these implants that comply with the FDA regulations.

FDA recommendations

The FDA recommends the patients who undergo this type of surgery the following:

  • Keep regular follow-up visits.
  • Pay attention to changes, you should inform your doctor if you develop unusual symptoms such as asymmetry, hardness, swelling and pain.
  • Be aware that breast implants are not made to last a lifetime.

Patients with breast implants should continue going to their regular breast screenings for early detection of breast cancer.

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