History – Breast Implants timeline


Thomas Cronin and Frank Gerow invent the silicone breast implant. 


The U.S. Food and Drug Administration (FDA) regulates silicone breast implants, subjecting them to controls and performance standards.1976 – US Congress passes the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Breast Implants are classified as moderate risk (Class II) devices and required to comply with general controls and performance standards. 


 -The FDA places breast implants in the more rigorous class III category, because of “reports of adverse events in the medical literature.”


Jean-Claude Mas established Poly Implant Prothese (PIP) based in France.


FDA calls for a voluntary moratorium on the use of silicone gel breast implants until safety has been reviewed.


Faced by massive lawsuits, Dow Corning filed for Chapter 11 bankruptcy; litigation was halted by the filing.


The FDA lifts its restrictions on silicone breast implants, clearing them for cosmetic use in women aged from 22. 

The FDA approves Allergan’s Natrelle Silicone Gel Filled Breast Implants and Mentor’s MemoryGel Silicone Gel Filled Breast Implants. The FDA based each approval on the manufacturers’ Core Studies. These clinical PMA studies followed hundreds of women with Silicone Gel Filled Breast Implants for a very short time – 4 years (Allergan) or 3 years (Mentor). The FDA determines that silicone filled breast implants are safe and effective. Based on these short studies the FDA concludes that the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.
However it came with conditions-  both Allergan and Mentor were ordered to conduct six post-approval studies to investigate the long-term performance and safety of their silicone gel filled breast implants. 

FDA recommends{ When the moratorium for breast implants was lifted in 2006}, MRI screening for silent silicone gel-filled breast implant rupture every 2 years and 3 years after breast augmmentation 


Breast implantation is the most popular form of plastic surgery in the United States with 318,123 augmentations performed, 62 percent of which used silicone implants.


 BioCell® textured breast implants FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. 

FDA U.S. Food and Drug takes significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. 


The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.


FDA issues MRI recommendations 

The FDA points out that in most cases neither you nor your surgeon will be able to find evidence of rupture by a physical examination. Breast MRIs are recommended after the first 3 years and then every 2 years from that point on. According to the FDA’s report many patients report that they were never told to undergo MRIs to check for rupture. MRIs can cost more than $2,000, and often insurance will not pay for an MRI to check for rupture. Many women undergo mammography to check for rupture instead, but FDA’s own research shows that it can cause implants to leak. 


FDA  finalized labeling guidance for breast implant manufacturers, including a boxed warning informing patients that the products have been associated with development of a type of cancer of the immune system.


ASPS annual meeting annonces that the likelihood of developing ALCL from Allergan Biocell textured implants was 1 in 300 at 10 years according to the largest series of studied patients from MSKCC. Of more concern was their mathematical modeling that the risk will increase to 1 in 100 at 20 years if the implants are left in place. The FDA has no mandate to remove these textured implants. 

Randall Feingold , MD FACS  is a Leading plastic surgeon in New York with expertises in capsulectomy and breast reconstruction. He is a pioneer in en bloc explant with more than 20 years experience ;“ “Many plastic surgeons still prefer to remove the implant and leave the capsules behind. This makes no sense to me since particulate matter from the textured surface is believed to be the causative agent in developing this cancer, and it is certainly left behind in the capsule if one merely peels the implant off the capsule (which feels like pulling apart two pieces of Velcro). In addition, the newer findings of BIA-Squamous Cell Carcinoma (very deadly) as well as other lymphomas were also presented. I have had one such patient who died from BIA-SCC as well as one patient each with B-cell lymphoma and T-cell lymphoma in smooth implant capsules. Since I have been able to perform hundreds of capsulectomies yearly with very low risk, I cannot in good conscience rationalize leaving capsule behind, and will continue to perform total en bloc capsulectomies in my explant patients regardless of whether they present for texture, contracture, rupture or symptoms of BII.”


The global breast implants market is $2.25 billion in 2022 at a compound annual growth rate (CAGR) of 7.43%. The breast implants market is expected to grow to $2.90 billion in 2026 at a compound annual growth rate (CAGR) of 6.57%.

Growing breast cancer incidences significantly contributed to the growth of the breast implants market. 












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