Silicone Breast Implants Deemed Safe as FDA Seeks More Data

by:Keyuan     2020-06-28
Allergan Inc.
The United States believes that Johnson & Johnson silicone breast augmentation surgery is safe. S.
After reviewing the clinical studies and side effects reported during the five-year marketing period, the regulator.
The agency said today that the analysis by the Food and Drug Administration did not find a link between the implant and the disease of the cornea, reproductive problems, breast cancer or other new side effects.
Women with breast implants should follow a doctor for routine MRI scans, because the chances of complications increase over time, the FDA said.
Safety of silicone-
Gel implants have been controversial since the products were re-introduced for aesthetic rather than medical use.
According to the American Association of Plastic Surgeons, an estimated 389,000 women underwent breast implants last year to rebuild or increase breast size after surgery.
About half of the patients chose silicone instead of saline implants.
\"Our review of this information continues to support the safety and effectiveness of silicone breast implants,\" said Jeffrey Schulen, director of the FDA\'s equipment and Radiation Health Center, today in a conference call with reporters
\"The risks and complications, while often occurring, are well known.
\"According to FDA data, 20% of women undergo breast implants for aesthetic reasons, and 50% of women need to remove breast implants within 10 years due to complications.
The most common safety risks are hardening around the capsule and additional surgery.
Pain, scars, wrinkles and broken implants are also common.
The FDA reiterated its warning in January that as many as 60 out of 5 million to 10 million breast implants patients worldwide had a rare cancer, known as intersex large cell lymphoma.
The risk is \"very small,\" Shu said \".
Confidence in the breast
Given the potential complications and the long term lack, the safety of the implant \"is undoubtedly short-sighted and contradictory\"
People in Washington said the term data
Based on the consumer group, they oppose the decision to return the product to the market, in e-commercemail.
The FDA approved silicone implants for cosmetic surgery in November 2006, and 14 years later, the FDA only allowed women to perform breast reconstruction because of concerns about injuries caused by leakage.
These products have been on the market since 1976, before the FDA began to regulate the equipment.
Allergan produces Natrelle silicone breast implants and saline breast implants.
Irving, California
S. -based companies sold $0. 319 billion in breast beauty equipment last year, accounting for six.
6% of income.
New Brunswick\'s mentor Department, New Jersey
Fabrication of memory gel silicone implants based on J & J.
Johnson & Johnson did not disclose sales of these products in its annual report.
The FDA has asked Allergan and Mentor to work in six
Approved research on implant safety and performance as marketing conditions.
The agency said today that it plans to hold an advisory group meeting in the coming months to discuss how to make these types of research more effective.
\"Information collected during follow-up visits continues to be provided regarding the long term
Chris Orman, spokesman for Implants, said in an email: \"Security of implantation\"
Mailing statement
The FDA is working with these companies to encourage compliance with research regulations.
Allergan said about 60% of the study participants completed a questionnaire in the first year after surgery.
They get $20 per year questionnaire and $100 for three follow-up questionnaires
Visit with their surgeon during 10-year period.
\"Our research compliance rate continues to increase every quarter,\" Caroline Van Hove, a spokeswoman for Allergan, said in an email. mail.
\"All the past and present studies on silicone breast augmentation involve thousands of patients, and I think it is safe to say that breast augmentation is now the most widely studied device in any medical product today.
Allergan fell 90 cents, or 1 cent.
1% to $81.
The composite transaction price of the New York Stock Exchange is 4 p. m.
Shares of Johnson & Johnson fell 42 cents to $66. 07.
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