Advertisement

Bayer's response to Sunday Night Q&A

Full story: Bayer's response to Sunday Night Q&A

BAYER RESPONSE TO SUNDAY NIGHT:

Does your company still stand by its permanent sterilization product, Essure?

Bayer stands behind the benefit-risk profile of Essure and takes all adverse event reports seriously. We closely collaborate with health and regulatory authorities, including the FDA, as well as medical professionals, to exchange all relevant information concerning the use and the benefit-risk profile of our products.

Patient well-being is the top priority at Bayer and there is great sympathy for anyone who experiences an adverse event from a medicine or medical device, regardless of the cause.

As with any medical device, users may experience potential side-effects. It is important that women who have questions or who experience side-effects speak with their doctor.

How would you describe the benefits of ESSURE?

Essure is an effective non-surgical permanent contraceptive option[i],[ii],[iii] that is indicated for women who desire permanent sterilisation by bilateral occlusion of the fallopian tubes.[iv] Essure offers the only permanent birth control (female sterilisation) choice that does not require skin incision and can be performed in the physician's office without general anaesthesia where appropriate facilities are available.[v],[vi]

The Essure system is 99.6% effective in women who had successful placement of the coils in each fallopian tube, based on up to ten years of clinical data.[vii] Women must continue to use another form of birth control until they have the Essure confirmation test performed three months after the procedure and their healthcare provider tells them that they can rely on Essure for birth control.

With all benefits there are risks? Some women have complained of perforated organs, metal coils lodged in colons, chronic pain, exhaustion, brain fog - doesn't sound good does it? And one of most common is device migration, despite the fact that they are meant to stay permanently in the fallopian tubes. It's not a marketers dream list is it?

Patient well-being is the top priority at Bayer and there is great sympathy for anyone who experiences an adverse event from a medicine or medical device, regardless of the cause.

As with any medical device, users may experience potential side-effects. It is important that women who have questions or who experience side-effects speak with their doctor.

The 'Instructions for Use' information on Essure includes details on side-effects reported about the product.[v] All adverse event data received by Bayer is analysed and Bayer works closely with the regulatory bodies across the world to monitor the safety profile of its products and devices, including Essure.

'''Why do you believe so many women are voicing their concerns about their own experiences with Essure?
'''
We cannot speculate on why women are speaking out. What we can say is that patient well-being is the top priority at Bayer and there is great sympathy for anyone who experiences an adverse event from a medicine or medical device, regardless of the cause.

As with any medical device, users may experience potential side-effects. It is important that women who have questions or who experience side-effects speak with their doctor.

There have been more than 5000 complaints made to the FDA here in the US. And more than 16,000 Essure complaints to Bayer. With the growing number of complaints about the product, surely this is of concern to a company like Bayer?

We are always concerned to hear of anyone experiencing an adverse event from a medicine or medical device, regardless of the cause. All adverse event data received by Bayer is analysed and Bayer works closely with the regulatory bodies across the world to monitor the safety profile of its products and devices, including Essure.

Some of these women have been told by their doctors that "it's all in their head" - do you believe that?

We cannot comment on individual cases or speculate on conversations we have not been involved in. Bayer stands behind the benefit-risk profile of Essure and takes all adverse event reports seriously. The 'Instructions for Use' information on Essure includes details on side-effects reported about the product.[v] All adverse event data received by Bayer is analysed and Bayer works closely with the regulatory bodies across the world to monitor the safety profile of its products and devices, including Essure.

'''Do you believe testing for metal allergies, given that the device is made up of nickel and titanium, is an important part of the preparation prior to implanting Essure into a woman's body?
'''
The Essure 'Information for Use' provided to doctors, and the brochure provided to patients highlights the material that the product is made from and does warn of potential allergic reactions. If a woman has any questions about the product or the materials that it is made from, they should discuss this with their doctor.

Do you believe that there should have been more testing done on this device prior to it being taken to market?

There was more than a decade of research and development effort prior to Essure receiving the European CE Mark approval in February 2001[viii],[ix] and the US FDA approval in 2002.

In addition, there has been over a decade of real world experience[xi] since then. It was approved by the Therapeutic Goods Administration in Australia in 1999[xii] and has been included on the New Zealand MEDSAFE Device List since 2008.[xiii] Bayer complies with all regulatory requirements around the world and it is these authorities that make the decision as to whether there is sufficient clinical data to grant marketing authorisation.

Does it concern you that high profile figures like Erin Brockovich are getting behind an action group to have Essure investigated further?

Bayer stands behind the benefit-risk profile of Essure and takes all adverse event reports seriously. We closely collaborate with health and regulatory authorities, including the FDA, as well as medical professionals, to exchange all relevant information concerning the use and the benefit-risk profile of our products.

Do you think it would be wise for the company to withdraw the product, even temporarily until all the complaints have been investigated and assessed?

Bayer stands behind the benefit-risk profile of Essure and takes all adverse event reports seriously. We closely collaborate with health and regulatory authorities, including the FDA, as well as medical professionals, to exchange all relevant information concerning the use and the benefit-risk profile of our products.

Is it common for the clinical trials for approval of a device be conducted by the manufacturer - that seems like a conflict of interest?

All research for the registration of a medicine or medical device, including clinical trials, is funded by the manufacturer as no other party would be interested to invest in this. All trials are strictly regulated by Government and health authorities, as well as being governed by Ethics Committees. In addition, they are implemented by third parties and often overseen by independent research organisations or independent Steering Committees.

A Citizen Petition was filed on February 20, 2015 to the FDA on behalf of thousands of women do you welcome this petition and feel that the benefits of Essure will at the end of the day outweigh the complaints
Patients are at the centre of all that Bayer does. We support people's rights to express their views and to exercise their legal rights.