The U.S Food and Drug Administration (FDA) sent warning notices to two breast implants manufacturing companies for not observing all the regulatory procedures to ensure the quality and safety of the product. The breast implant company Allergan of Irvine in California received the warning letter from the FDA for violating two quality assurance rules set by the authority.
The company did not conduct the tests to ensure the harmlessness of the breast implants in the long term and risk associated with the use of the two designs of the implants. Last year, both of these models were made unavailable for sale by the company.
The other manufacturer, Ideal Implant Incorporated of Dallas, Texas received the warning letter from the FDA and already went through inspection this year. The breast implant company received the notice for not following good quality ensuring practices in the manufacturing procedure of the implants. The company also did not report the inspection event according to the requirements due to which the warning letter was issued.
The warning letter issued to Allergan mentioned that the companies manufacturing silicone breast implants must test the prolonged effectiveness and risk associated with the long-term use of the implants after the approval of the breast implant model. The company should also give scientific details about their product that were not mentioned in the clinical trial before launching the product into the market.
The letter also stated that the company should conduct the studies to test the longevity of the implants even in the case of removing the specific model from the market to ensure that the people already using the model do not suffer from any risk in the long term.
The director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, Binita Ashar, M.D. said that the requirements imposed by the FDA after the approval of the product are essential to ensure that the medical device does not pose any side effects. She also said that previously those implants were made unavailable since those models were associated with increasing the risk of anaplastic large cell lymphoma caused due to silicone gel breast implants.
The FDA has also warned the company of serious action if the manufacturer fails to comply with the quality requirements of the FDA and amend the violations done by the breast implant company.
The warning letter to Ideal Implant Incorporation stated that the company should comply with the quality assurance rules and regulations and fulfill the requirements of ideal manufacturing procedures. It was also mentioned in the letter that the manufacturing company should report the surveillance events and safety risks and issues in the medical devices to the FDA under the regulation of Medical Device Reporting (MDR).
Considering this letter, Dr. Ashar said that the inspection of the company earlier this year revealed that the company is possibly violating the Federal Food, Drug, and Cosmetic Act. She also said that the surveillance system of the FDA ensures that the manufacturing companies are following the regulations of the FDA during all stages of the production of the product.
The inspectors revealed that the manufacturing company was unable to report the issues in the product to the FDA which could lead to serious consequences such as injury or death of the patient.
The Adverse Event Reporting program of the FDA deals with any breast implant-related issues reported by professionals as well as consumers of the product. The FDA takes action according to the reports to ensure safety and minimal risk associated with medical devices.